- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02439775
SPYRAL HTN-ON MED-studie
Global klinisk studie av njurdenervering med Symplicity Spyral™ Multi-electrode Renal Denervation System hos patienter med okontrollerad hypertoni på standardmedicinsk terapi (SPYRAL HTN-ON MED)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Kogarah, Australien
- St. George Hospital
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Perth, Australien
- Royal Perth
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Victoria
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Melbourne, Victoria, Australien, 3004
- Alfred Hospital
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Toulouse, Frankrike
- Clinique Pasteur
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Alabama
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Huntsville, Alabama, Förenta staterna, 35801
- Heart Center Research, LLC
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California
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Stanford, California, Förenta staterna, 94305
- Stanford Hospital and Clinics
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06520
- Yale New Haven Hospital
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20422
- Washington DC VA Medical Center
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Florida
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Jacksonville, Florida, Förenta staterna, 32207
- Baptist Medical Center Jacksonville
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Jacksonville, Florida, Förenta staterna, 32216
- Memorial Hospital Jacksonville
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Tallahassee, Florida, Förenta staterna, 32308
- Tallahassee Research Institute
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Georgia
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Atlanta, Georgia, Förenta staterna, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Förenta staterna, 30309
- Piedmont Heart Institute
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Iowa
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West Des Moines, Iowa, Förenta staterna, 50266
- Iowa Heart Center
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536
- University of Kentucky
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Michigan
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Pontiac, Michigan, Förenta staterna, 48341
- St Joseph Mercy Oakland
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Southfield, Michigan, Förenta staterna, 48075
- Providence Hospital
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55407
- Minneapolis Heart Institute Foundation
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Mississippi
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Hattiesburg, Mississippi, Förenta staterna, 39401
- Hattiesburg Clinic
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Tupelo, Mississippi, Förenta staterna, 38801
- Cardiology Associates Research LLC
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Missouri
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St Louis, Missouri, Förenta staterna, 63110
- Barnes-Jewish Hospital
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New Jersey
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Livingston, New Jersey, Förenta staterna, 07039
- Saint Barnabas Medical Center
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New York
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Manhasset, New York, Förenta staterna, 11030
- North Shore University Hospital
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New York, New York, Förenta staterna, 10029
- Mount Sinai Medical Center
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New York, New York, Förenta staterna, 10021
- Weill Cornell Medical College/The New York Presbyterian Hospital
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health & Science University Hospital
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Pennsylvania
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Harrisburg, Pennsylvania, Förenta staterna, 17011
- PinnacleHealth Cardiovascular Institute
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Hospital of the University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02906
- The Miriam Hospital
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South Carolina
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Anderson, South Carolina, Förenta staterna, 29621
- AnMed Health
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Centennial Medical Center
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Texas
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Dallas, Texas, Förenta staterna, 75226
- Baylor Heart & Vascular Hospital
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West Virginia
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Charleston, West Virginia, Förenta staterna, 25304
- Charleston Area Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53215
- Aurora St. Luke's Medical Center
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Athens, Grekland, 11527
- Hippokration General Hospital of Athens
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Thessaloniki, Grekland, 54621
- University General Hospital of Thessaloniki (AHEPA)
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Galway, Irland
- Galway University Hospital
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Osaka, Japan
- Saiseikai Nakatsu Hospital
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Hyōgo
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Takarazuka, Hyōgo, Japan
- Higashi Takarazuka Satoh Hospital
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Okamoto
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Kamakura, Okamoto, Japan
- Shonan Kamakura General Hospital
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Tochigi
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Shimotsuke, Tochigi, Japan, 329-0498
- Jichi Medical University Hospital
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Tokyo
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Chiyoda City, Tokyo, Japan, 101-8643
- Mitsui Memorial Hospital
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Ontario
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Hamilton, Ontario, Kanada
- Hamilton Heath
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Toronto, Ontario, Kanada
- St. Michael's Hospital
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Bournemouth, Storbritannien
- Royal Bournemouth Hospital
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Cardiff, Storbritannien
- Cardiff and Vale University Health Board - University Hospital of Wales
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Exeter, Storbritannien, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
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London, Storbritannien, W12 0HS
- Imperial College Healthcare NHS Trust
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Bad Krozingen, Tyskland, 79189
- Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
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Erlangen, Tyskland, 91054
- Universitätsklinikum Erlangen
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Homburg, Tyskland, 66421
- Universitatsklinikum des Saarlandes
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Leipzig, Tyskland, 04289
- Herzzentrum Leipzig, Universitätsklinik
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Lübeck, Tyskland, 23560
- Sana Kliniken Lubeck
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Wels, Österrike, 4600
- Klinikum Wels-Grieskirchen
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Individen har kontorssystoliskt blodtryck (SBP) ≥ 150 mmHg och
- Individen har 24-timmars ambulatorisk blodtrycksövervakning (ABPM) genomsnittligt SBP ≥ 140 mmHg och < 170 mmHg.
Exklusions kriterier:
- Individen saknar lämplig njurartäranatomi.
- Individen har uppskattad glomerulär filtrationshastighet (eGFR) på
- En person har typ 1 diabetes mellitus eller dåligt kontrollerad typ 2 diabetes mellitus.
- Individen har en eller flera episoder av ortostatisk hypotoni.
- Individen behöver kroniskt syrgasstöd eller mekanisk ventilation annat än nattligt andningsstöd för sömnapné.
- Individen har primär pulmonell hypertoni.
- Individen är gravid, ammar eller planerar att bli gravid.
- Individen har ofta intermittent eller kronisk smärta som resulterar i behandling med icke-steroida antiinflammatoriska läkemedel (NSAID) under två eller fler dagar per vecka under månaden före inskrivningen
- Individen har stabil eller instabil angina inom 3 månader efter inskrivning, hjärtinfarkt inom 3 månader efter inskrivning; hjärtsvikt, cerebrovaskulär olycka eller övergående ischemisk attack eller förmaksflimmer när som helst.
- Enskild arbetar nattskift.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Njurdenervering
Renal angiografi och renal denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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Efter en renal angiografi enligt standardprocedurer förblir försökspersonerna blinda och behandlas omedelbart med njurdenerveringsprocedur efter randomisering.
Andra namn:
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Sham Comparator: Skumprocedur
Renal angiografi
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Efter en njurangiografi enligt standardprocedurer förblir försökspersonerna blinda och stannar kvar på kateteriseringslaboratoriets bord i minst 20 minuter innan introducerslidan tas bort.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Förändring i systoliskt blodtryck mätt med 24-timmars ambulatorisk blodtrycksövervakning (ABPM)
Tidsram: Från baslinjen till 6 månader efter ingreppet
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Baslinjejusterad förändring (med analys av kovarians) i systoliskt blodtryck (SBP) från baslinje (kontrollbesök 2) till 6 månader efter proceduren mätt med 24-timmars ambulatorisk blodtrycksövervakning (ABPM).
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Från baslinjen till 6 månader efter ingreppet
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Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Tidsram: From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)
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The Primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as composite of the following events: All-cause mortality, End stage renal Disease (ESRD), Significant embolic event resulting in end-organ damage, Renal artery perforation requiring intervention, Renal artery dissection requiring intervention, Vascular complications, Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core laboratory, through one-month post-randomization (6-months for new renal artery stenosis)
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From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Användning av antihypertensiva läkemedel och förändringar till 6 månader
Tidsram: Från baslinjen till 6 månader efter ingreppet
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Antal mediciner från baslinjen (kontrollbesök 2) till 6 månader efter proceduren
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Från baslinjen till 6 månader efter ingreppet
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Antihypertensiv medicin börda till 6 månader
Tidsram: Från baslinjen till 6 månader efter proceduren
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Baserat på de ordinerade medicinerna som rapporterades, beräknades läkemedelsbördan med hjälp av Läkemedelsindex 2-poäng som är ett sammansatt index baserat på doserna av antihypertensiva läkemedel multiplicerat med antalet ordinerade läkemedel; alla klasser (ACE/ARB, kalciumkanalblockerare, etc.) ansågs likvärdiga i styrka. Högre poäng indikerar högre doser som ordineras över standarddosen. Minsta värde 0; Inget maxvärde |
Från baslinjen till 6 månader efter proceduren
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Läkemedelsförändringar
Tidsram: Baslinje till 6 månader efter proceduren
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Patienter som hade läkemedelsförändringar baserat på läkemedelstestdata för läkemedelsindex 2.
Läkemedelsindex 2-poäng är ett sammansatt index baserat på doserna av blodtryckssänkande läkemedel multiplicerat med antalet ordinerade läkemedel; alla klasser (ACE/ARB, kalciumkanalblockerare, etc.) ansågs likvärdiga i styrka.
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Baslinje till 6 månader efter proceduren
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Förekomst av att uppnå målkontorssystoliskt blodtryck
Tidsram: Från baslinjen till 6 månader efter ingreppet
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Förekomst av uppnående av systoliskt blodtryck (SBP<140 mmHg) 6 månader efter ingreppet.
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Från baslinjen till 6 månader efter ingreppet
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Change in Office Systolic Blood Pressure to 6-months
Tidsram: From baseline to 6 months post-procedure
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Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure
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From baseline to 6 months post-procedure
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Change in Systolic Blood Pressure as Measured by 24-hour ABPM 12 Months
Tidsram: From Baseline to 12 months post procedure
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Change in systolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
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From Baseline to 12 months post procedure
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Change in Systolic Blood Pressure as Measured by 24-hour ABPM 24-months
Tidsram: From baseline to 24 months post-procedure
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Change in systolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 24 months post-procedure
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Change in Systolic Blood Pressure as Measured by 24-hour ABPM 36-months
Tidsram: From baseline to 36 months post-procedure
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Change in systolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 36 months post-procedure
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Change in Office Systolic Blood Pressure to 12-months
Tidsram: From Baseline to 12 months post procedure
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Change in office systolic blood pressure from baseline (screening visit 2) to 12 months.
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From Baseline to 12 months post procedure
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Change in Office Systolic Blood Pressure to 24-months
Tidsram: From baseline to 24 months post-procedure
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Change in office systolic blood pressure from baseline (screening visit 2) to 24 months.
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From baseline to 24 months post-procedure
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Change in Office Systolic Blood Pressure to 36-months
Tidsram: From baseline to 36 months post-procedure
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Change in office systolic blood pressure from baseline (screening visit 2) to 36 months.
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From baseline to 36 months post-procedure
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Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 12-months
Tidsram: From Baseline to 12 months post procedure
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Change in diastolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From Baseline to 12 months post procedure
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Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 24-months
Tidsram: From baseline to 24 months post-procedure
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Change in diastolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 24 months post-procedure
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Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 36-months
Tidsram: From baseline to 36 months post-procedure
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Change in diastolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 36 months post-procedure
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Change in Office Diastolic Blood Pressure 12 Months
Tidsram: From baseline to 12 months post-procedure
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Change in office diastolic blood pressure from baseline (screening visit 2) to 12 months.
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From baseline to 12 months post-procedure
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Change in Office Diastolic Blood Pressure 24 Months
Tidsram: From baseline to 24 months post-procedure
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Change in office diastolic blood pressure from baseline (screening visit 2) to 24 months.
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From baseline to 24 months post-procedure
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Change in Office Diastolic Blood Pressure 36 Months
Tidsram: From baseline to 36 months post-procedure
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Change in office diastolic blood pressure from baseline (screening visit 2) to 36 months.
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From baseline to 36 months post-procedure
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Number of Participants Achieving Target Office Systolic Blood Pressure 12 Months
Tidsram: From baseline to 12 months post-procedure
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Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
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From baseline to 12 months post-procedure
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Number of Participants Achieving Target Office Systolic Blood Pressure 24 Months
Tidsram: From baseline to 24 months post-procedure
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Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg).
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From baseline to 24 months post-procedure
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Number of Participants Achieving Target Office Systolic Blood Pressure. 36 Months
Tidsram: From baseline to 36 months post-procedure
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Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
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From baseline to 36 months post-procedure
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Number of Participants With All Cause Mortality
Tidsram: From Baseline to 36-months post procedure
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From Baseline to 36-months post procedure
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Number of Participants With End-Stage Renal Disease (ESRD)
Tidsram: From Baseline to 36-months post-procedure
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End-stage Renal Disease (ESRD) - defined as two or more eGFR measurements <15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:
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From Baseline to 36-months post-procedure
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Number of Participants With Significant Embolic Event Resulting in End-organ Damage
Tidsram: From Baseline to 36 months post-procedure
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From Baseline to 36 months post-procedure
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Number of Participants With Renal Artery Perforation Requiring Intervention
Tidsram: From Baseline to 36 month post-procedure
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Renal artery perforation requiring intervention
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From Baseline to 36 month post-procedure
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Number of Participants With Renal Artery Dissection Requiring Intervention
Tidsram: From Baseline to 36 months post-procedure
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Number of Participants with Renal artery dissection requiring intervention
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From Baseline to 36 months post-procedure
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Number of Participants With Vascular Complications
Tidsram: From Baseline to 36 months post-procedure
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Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).
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From Baseline to 36 months post-procedure
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Number of Participants With Hospitalization for Hypertensive Crisis Not Related to Confirmed Non-adherence With Medications and/or the Protocol.
Tidsram: From Baseline to 36 months post-procedure
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From Baseline to 36 months post-procedure
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Number of Participants With New Renal Artery Stenosis > 70%, Confirmed by Angiography and as Determined by the Angiographic Core Laboratory
Tidsram: From Baseline to 36 months post-procedure
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From Baseline to 36 months post-procedure
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Number of Participants With ≥ 40% Decline in eGFR
Tidsram: From baseline to 36 months post-procedure
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From baseline to 36 months post-procedure
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Number of Participants With Increase in Serum Creatinine >50% From Screening Visit 2 (Baseline)
Tidsram: From baseline to 36 months post-procedure
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From baseline to 36 months post-procedure
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Number of Participants With New Myocardial Infarct
Tidsram: From baseline to 36 months post-procedure
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From baseline to 36 months post-procedure
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Number of Participants With New Stroke
Tidsram: From baseline to 36 months post-procedure
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From baseline to 36 months post-procedure
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Number of Participants With Renal Artery Re-intervention
Tidsram: From baseline to 36 months post-procedure
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From baseline to 36 months post-procedure
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Number of Participants With Major Bleeding According to TIMI Definition
Tidsram: From baseline to 36 months post-procedure
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Major bleeding according to TIMI definition (i.e.
intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure
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From baseline to 36 months post-procedure
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Change in Diastolic Blood Pressure as Measured by 24-hour (ABPM) 6-months
Tidsram: From baseline to 6 months post-procedure
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Change in diastolic blood pressure from baseline (screening visit 2) to 6 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 6 months post-procedure
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Change in Office Diastolic Blood Pressure to 6-months
Tidsram: From baseline to 6 months post-procedure
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Change in office diastolic blood pressure from baseline (screening visit 2) to 6 months post-procedure
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From baseline to 6 months post-procedure
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Antihypertensive Medication Burden to 36-months
Tidsram: From baseline to 36 months post-procedure
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Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison) |
From baseline to 36 months post-procedure
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Antihypertensive Medication Burden to 24-months
Tidsram: From baseline to 24 months post-procedure
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Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison) |
From baseline to 24 months post-procedure
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Antihypertensive Medication Burden to 12-Months
Tidsram: From Baseline to 12 months post-procedure
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Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison) |
From Baseline to 12 months post-procedure
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Raymond Townsend, MD, University of Pennsylvania
- Huvudutredare: David Kandzari, MD, Piedmont Hospital
- Huvudutredare: Michael Böhm, MD, Universitätskliniken des Saarlandes
- Huvudutredare: Kazuomi Kario, MD, Jichi Medical University
Publikationer och användbara länkar
Allmänna publikationer
- Mahfoud F, Kandzari DE, Kario K, Townsend RR, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Dimitriadis K, Choi JW, East C, D'Souza R, Sharp ASP, Ewen S, Walton A, Hopper I, Brar S, McKenna P, Fahy M, Bohm M. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. 2022 Apr 9;399(10333):1401-1410. doi: 10.1016/S0140-6736(22)00455-X. Epub 2022 Apr 4.
- Kandzari DE, Hickey GL, Pocock SJ, Weber MA, Bohm M, Cohen SA, Fahy M, Lamberti G, Mahfoud F. Prioritised endpoints for device-based hypertension trials: the win ratio methodology. EuroIntervention. 2021 Apr 2;16(18):e1496-e1502. doi: 10.4244/EIJ-D-20-01090.
- Kario K, Weber MA, Bohm M, Townsend RR, Mahfoud F, Schmieder RE, Tsioufis K, Cohen SA, Fahy M, Kandzari DE. Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial. Clin Res Cardiol. 2021 May;110(5):725-731. doi: 10.1007/s00392-020-01718-6. Epub 2020 Aug 1.
- Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
- Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.
- Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.
- Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Liu M, DeBruin V, Brar S, Bohm M. Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Epub 2025 May 20.
- Townsend RR, Ferdinand KC, Kandzari DE, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, David S, Steigerwalt S, Walton A, Hopper I, Bertolet B, Sharif F, Fengler K, Fahy M, Hettrick DA, Brar S, Bohm M. Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED. Hypertension. 2024 May;81(5):1095-1105. doi: 10.1161/HYPERTENSIONAHA.123.22251. Epub 2024 Feb 5.
- Kandzari DE, Townsend RR, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, Konstantinidis D, Choi J, East C, Lauder L, Cohen DL, Kobayashi T, Schmid A, Lee DP, Ma A, Weil J, Agdirlioglu T, Schlaich MP, Shetty S, Devireddy CM, Lea J, Aoki J, Sharp ASP, Anderson R, Fahy M, DeBruin V, Brar S, Bohm M; SPYRAL HTN-ON MED Investigators. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823. doi: 10.1016/j.jacc.2023.08.045.
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- SPYRAL HTN-ON MED
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