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SPYRAL HTN-ON MED undersøgelse

9. juni 2026 opdateret af: Medtronic Vascular

Global klinisk undersøgelse af renal denervering med det enkle Spyral™ Multi-electrode Renal Denervation System hos patienter med ukontrolleret hypertension på standard medicinsk terapi (SPYRAL HTN-ON MED)

Formålet med denne undersøgelse er at teste hypotesen om, at renal denervering sænker blodtrykket og er sikker, når den studeres i nærværelse af op til tre standard antihypertensive medicin.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Formålet med denne undersøgelse er at teste hypotesen om, at renal denervering er sikker og reducerer systolisk blodtryk (SBP) hos patienter med ukontrolleret hypertension på en, to eller tre standard antihypertensive medicin sammenlignet med en falsk kontrol i samme population. I denne undersøgelse er "ukontrolleret hypertension" defineret som et systolisk blodtryk på kontoret (SBP) ≥ 150 mmHg og <180 mmHg, et kontordiastolisk blodtryk (DBP) ≥90 mmHg og en 24-timers ambulant blodtryksovervågning (ABPM) gennemsnitlig SBP ≥140 mmHg til <170 mmHg, som alle er målt ved screeningsbesøg. De opnåede data vil blive brugt til at bekræfte effekten af ​​renal denervering på forhøjet blodtryk hos patienter på 1, 2 eller 3 antihypertensive medicin.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

337

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Kogarah, Australien
        • St. George Hospital
      • Perth, Australien
        • Royal Perth
    • Victoria
      • Melbourne, Victoria, Australien, 3004
        • Alfred Hospital
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Heath
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
  • Det Forenede Kongerige
      • Bournemouth, Det Forenede Kongerige
        • Royal Bournemouth Hospital
      • Cardiff, Det Forenede Kongerige
        • Cardiff and Vale University Health Board - University Hospital of Wales
      • Exeter, Det Forenede Kongerige, EX2 5DW
        • Royal Devon & Exeter NHS Foundation Trust
      • London, Det Forenede Kongerige, W12 0HS
        • Imperial College Healthcare NHS Trust
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35801
        • Heart Center Research, LLC
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford Hospital and Clinics
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale New Haven Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20422
        • Washington DC VA Medical Center
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Baptist Medical Center Jacksonville
      • Jacksonville, Florida, Forenede Stater, 32216
        • Memorial Hospital Jacksonville
      • Tallahassee, Florida, Forenede Stater, 32308
        • Tallahassee Research Institute
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Heart Institute
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Iowa Heart Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University Of Kentucky
    • Michigan
      • Pontiac, Michigan, Forenede Stater, 48341
        • St Joseph Mercy Oakland
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Minneapolis Heart Institute Foundation
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39401
        • Hattiesburg Clinic
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Cardiology Associates Research LLC
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Barnes-Jewish Hospital
    • New Jersey
      • Livingston, New Jersey, Forenede Stater, 07039
        • Saint Barnabas Medical Center
    • New York
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University Hospital
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Medical Center
      • New York, New York, Forenede Stater, 10021
        • Weill Cornell Medical College/The New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University Hospital
    • Pennsylvania
      • Harrisburg, Pennsylvania, Forenede Stater, 17011
        • PinnacleHealth Cardiovascular Institute
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of the University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • The Miriam Hospital
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Centennial Medical Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75226
        • Baylor Heart & Vascular Hospital
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Aurora St. Luke's Medical Center
  • Frankrig
      • Toulouse, Frankrig
        • Clinique Pasteur
  • Grækenland
      • Athens, Grækenland, 11527
        • Hippokration General Hospital of Athens
      • Thessaloniki, Grækenland, 54621
        • University General Hospital of Thessaloniki (AHEPA)
  • Irland
      • Galway, Irland
        • Galway University Hospital
  • Japan
      • Osaka, Japan
        • Saiseikai Nakatsu Hospital
    • Hyōgo
      • Takarazuka, Hyōgo, Japan
        • Higashi Takarazuka Satoh Hospital
    • Okamoto
      • Kamakura, Okamoto, Japan
        • Shonan Kamakura General Hospital
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Chiyoda City, Tokyo, Japan, 101-8643
        • Mitsui Memorial Hospital
  • Tyskland
      • Bad Krozingen, Tyskland, 79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
      • Erlangen, Tyskland, 91054
        • Universitatsklinikum Erlangen
      • Homburg, Tyskland, 66421
        • Universitatsklinikum des Saarlandes
      • Leipzig, Tyskland, 04289
        • Herzzentrum Leipzig, Universitätsklinik
      • Lübeck, Tyskland, 23560
        • Sana Kliniken Lübeck
  • Østrig
      • Wels, Østrig, 4600
        • Klinikum Wels-Grieskirchen

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Individet har kontorsystolisk blodtryk (SBP) ≥ 150 mmHg og
  • Individet har 24-timers ambulatorisk blodtryksovervågning (ABPM) gennemsnitligt SBP ≥ 140 mmHg og < 170 mmHg.

Ekskluderingskriterier:

  • Individet mangler passende nyrearterieanatomi.
  • Individet har estimeret glomerulær filtrationshastighed (eGFR) på
  • Individet har type 1 diabetes mellitus eller dårligt kontrolleret type 2 diabetes mellitus.
  • Individet har en eller flere episoder med ortostatisk hypotension.
  • Individuel kræver kronisk iltstøtte eller mekanisk ventilation ud over natlig åndedrætsstøtte til søvnapnø.
  • Individet har primær pulmonal hypertension.
  • Personen er gravid, ammer eller planlægger at blive gravid.
  • Individet har hyppige intermitterende eller kroniske smerter, der resulterer i behandling med ikke-steroide antiinflammatoriske lægemidler (NSAID'er) i to eller flere dage om ugen i løbet af måneden før indskrivning
  • Individet har stabil eller ustabil angina inden for 3 måneder efter tilmelding, myokardieinfarkt inden for 3 måneder efter tilmelding; hjertesvigt, cerebrovaskulær ulykke eller forbigående iskæmisk anfald eller atrieflimren til enhver tid.
  • Individuel arbejder nathold.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Renal denervering
Renal angiografi og renal denervation (Symplicity Spyral™ multi-elektrode renal denervation system)
Enhed: Simplicity Spyral™ multi-elektrode renal denervering system
Efter en renal angiografi i henhold til standardprocedurer forbliver forsøgspersonerne blinde og behandles straks med den renale denerveringsprocedure efter randomisering.
Andre navne:
  • Renal angiografi
  • Renal denervering
Sham-komparator: Sham procedure
Renal angiografi
Procedure: Sham procedure
Efter en renal angiografi i henhold til standardprocedurer forbliver forsøgspersonerne blinde og forbliver på kateteriseringslaboratoriet i mindst 20 minutter før fjernelse af introducerskeden.
Andre navne:
  • Renal angiografi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i systolisk blodtryk målt ved 24-timers ambulatorisk blodtryksovervågning (ABPM)
Tidsramme: Fra baseline til 6 måneder efter proceduren
Baseline justeret ændring (ved hjælp af analyse af kovarians) i systolisk blodtryk (SBP) fra baseline (screeningsbesøg 2) til 6 måneder efter proceduren målt ved 24-timers ambulant blodtryksmonitorering (ABPM).
Fra baseline til 6 måneder efter proceduren
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Tidsramme: From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)
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)
From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Brug af antihypertensiv medicin og ændringer til 6 måneder
Tidsramme: Fra baseline til 6 måneder efter proceduren
Antal medicin fra baseline (screeningsbesøg 2) til 6 måneder efter proceduren
Fra baseline til 6 måneder efter proceduren
Antihypertensiv medicin byrde til 6 måneder
Tidsramme: Fra baseline til 6 måneder efter proceduren

Baseret på den ordinerede medicin, der blev rapporteret, blev medicinbyrden beregnet ved hjælp af Medicinindeks 2-score, som er et sammensat indeks baseret på doserne af antihypertensiv medicin ganget med antallet af ordineret medicin; alle klasser (ACE/ARB, calciumkanalblokkere osv.) blev betragtet som ækvivalente i styrke. Højere score indikerer højere doser, der er ordineret over standarddosis.

Minimumværdi 0; Ingen maksimumværdi
Fra baseline til 6 måneder efter proceduren
Medicinændringer
Tidsramme: Baseline til 6 måneder efter proceduren
Patienter, der havde medicinændringer baseret på medicinindeks 2 lægemiddeltestdata. Medicinindeks 2-score er et sammensat indeks baseret på doserne af antihypertensiv medicin ganget med antallet af ordineret medicin; alle klasser (ACE/ARB, calciumkanalblokkere osv.) blev betragtet som ækvivalente i styrke.
Baseline til 6 måneder efter proceduren
Forekomst af opnåelse af målkontorets systolisk blodtryk
Tidsramme: Fra baseline til 6 måneder efter proceduren
Forekomst af opnåelse af systolisk blodtryk (SBP <140 mmHg) 6 måneder efter proceduren.
Fra baseline til 6 måneder efter proceduren
Change in Office Systolic Blood Pressure to 6-months
Tidsramme: From baseline to 6 months post-procedure
Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure
From baseline to 6 months post-procedure
Change in Systolic Blood Pressure as Measured by 24-hour ABPM 12 Months
Tidsramme: From Baseline to 12 months post procedure
Change in systolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
From Baseline to 12 months post procedure
Change in Systolic Blood Pressure as Measured by 24-hour ABPM 24-months
Tidsramme: From baseline to 24 months post-procedure
Change in systolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
From baseline to 24 months post-procedure
Change in Systolic Blood Pressure as Measured by 24-hour ABPM 36-months
Tidsramme: From baseline to 36 months post-procedure
Change in systolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
From baseline to 36 months post-procedure
Change in Office Systolic Blood Pressure to 12-months
Tidsramme: From Baseline to 12 months post procedure
Change in office systolic blood pressure from baseline (screening visit 2) to 12 months.
From Baseline to 12 months post procedure
Change in Office Systolic Blood Pressure to 24-months
Tidsramme: From baseline to 24 months post-procedure
Change in office systolic blood pressure from baseline (screening visit 2) to 24 months.
From baseline to 24 months post-procedure
Change in Office Systolic Blood Pressure to 36-months
Tidsramme: From baseline to 36 months post-procedure
Change in office systolic blood pressure from baseline (screening visit 2) to 36 months.
From baseline to 36 months post-procedure
Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 12-months
Tidsramme: From Baseline to 12 months post procedure
Change in diastolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
From Baseline to 12 months post procedure
Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 24-months
Tidsramme: From baseline to 24 months post-procedure
Change in diastolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
From baseline to 24 months post-procedure
Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 36-months
Tidsramme: From baseline to 36 months post-procedure
Change in diastolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
From baseline to 36 months post-procedure
Change in Office Diastolic Blood Pressure 12 Months
Tidsramme: From baseline to 12 months post-procedure
Change in office diastolic blood pressure from baseline (screening visit 2) to 12 months.
From baseline to 12 months post-procedure
Change in Office Diastolic Blood Pressure 24 Months
Tidsramme: From baseline to 24 months post-procedure
Change in office diastolic blood pressure from baseline (screening visit 2) to 24 months.
From baseline to 24 months post-procedure
Change in Office Diastolic Blood Pressure 36 Months
Tidsramme: From baseline to 36 months post-procedure
Change in office diastolic blood pressure from baseline (screening visit 2) to 36 months.
From baseline to 36 months post-procedure
Number of Participants Achieving Target Office Systolic Blood Pressure 12 Months
Tidsramme: From baseline to 12 months post-procedure
Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
From baseline to 12 months post-procedure
Number of Participants Achieving Target Office Systolic Blood Pressure 24 Months
Tidsramme: From baseline to 24 months post-procedure
Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg).
From baseline to 24 months post-procedure
Number of Participants Achieving Target Office Systolic Blood Pressure. 36 Months
Tidsramme: From baseline to 36 months post-procedure
Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
From baseline to 36 months post-procedure
Number of Participants With All Cause Mortality
Tidsramme: From Baseline to 36-months post procedure
From Baseline to 36-months post procedure
Number of Participants With End-Stage Renal Disease (ESRD)
Tidsramme: From Baseline to 36-months post-procedure

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:

  • Volume management refractory to diuretics
  • Hyperkalemia unmanageable by diet and diuretics
  • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
  • Symptoms of uremia, nausea, vomiting
From Baseline to 36-months post-procedure
Number of Participants With Significant Embolic Event Resulting in End-organ Damage
Tidsramme: From Baseline to 36 months post-procedure
From Baseline to 36 months post-procedure
Number of Participants With Renal Artery Perforation Requiring Intervention
Tidsramme: From Baseline to 36 month post-procedure
Renal artery perforation requiring intervention
From Baseline to 36 month post-procedure
Number of Participants With Renal Artery Dissection Requiring Intervention
Tidsramme: From Baseline to 36 months post-procedure
Number of Participants with Renal artery dissection requiring intervention
From Baseline to 36 months post-procedure
Number of Participants With Vascular Complications
Tidsramme: From Baseline to 36 months post-procedure
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).
From Baseline to 36 months post-procedure
Number of Participants With Hospitalization for Hypertensive Crisis Not Related to Confirmed Non-adherence With Medications and/or the Protocol.
Tidsramme: From Baseline to 36 months post-procedure
From Baseline to 36 months post-procedure
Number of Participants With New Renal Artery Stenosis > 70%, Confirmed by Angiography and as Determined by the Angiographic Core Laboratory
Tidsramme: From Baseline to 36 months post-procedure
From Baseline to 36 months post-procedure
Number of Participants With ≥ 40% Decline in eGFR
Tidsramme: From baseline to 36 months post-procedure
From baseline to 36 months post-procedure
Number of Participants With Increase in Serum Creatinine >50% From Screening Visit 2 (Baseline)
Tidsramme: From baseline to 36 months post-procedure
From baseline to 36 months post-procedure
Number of Participants With New Myocardial Infarct
Tidsramme: From baseline to 36 months post-procedure
From baseline to 36 months post-procedure
Number of Participants With New Stroke
Tidsramme: From baseline to 36 months post-procedure
From baseline to 36 months post-procedure
Number of Participants With Renal Artery Re-intervention
Tidsramme: From baseline to 36 months post-procedure
From baseline to 36 months post-procedure
Number of Participants With Major Bleeding According to TIMI Definition
Tidsramme: From baseline to 36 months post-procedure
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
From baseline to 36 months post-procedure
Change in Diastolic Blood Pressure as Measured by 24-hour (ABPM) 6-months
Tidsramme: From baseline to 6 months post-procedure
Change in diastolic blood pressure from baseline (screening visit 2) to 6 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
From baseline to 6 months post-procedure
Change in Office Diastolic Blood Pressure to 6-months
Tidsramme: From baseline to 6 months post-procedure
Change in office diastolic blood pressure from baseline (screening visit 2) to 6 months post-procedure
From baseline to 6 months post-procedure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antihypertensive Medication Burden to 36-months
Tidsramme: From baseline to 36 months post-procedure

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
Antihypertensive Medication Burden to 24-months
Tidsramme: From baseline to 24 months post-procedure

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
Antihypertensive Medication Burden to 12-Months
Tidsramme: From Baseline to 12 months post-procedure

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medtronic Vascular

Efterforskere

  • Ledende efterforsker: Raymond Townsend, MD, University of Pennsylvania
  • Ledende efterforsker: David Kandzari, MD, Piedmont Hospital
  • Ledende efterforsker: Michael Böhm, MD, Universitätskliniken des Saarlandes
  • Ledende efterforsker: Kazuomi Kario, MD, Jichi Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juli 2015

Primær færdiggørelse (Faktiske)

18. august 2022

Studieafslutning (Faktiske)

14. august 2025

Datoer for studieregistrering

Først indsendt

28. april 2015

Først indsendt, der opfyldte QC-kriterier

6. maj 2015

Først opslået (Anslået)

12. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SPYRAL HTN-ON MED

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjerte-kar-sygdomme

Kliniske forsøg med Simplicity Spyral™ multi-elektrode renal denervering system

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Burundi

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner