- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02439775
SPYRAL HTN-ON MED 연구
표준 의학 요법(SPYRAL HTN-ON MED)에서 조절되지 않는 고혈압 환자를 대상으로 Symplicity Spyral™ 다중 전극 신장 신경 차단 시스템을 사용한 신장 신경 차단에 대한 글로벌 임상 연구
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Athens, 그리스, 11527
- Hippokration General Hospital of Athens
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Thessaloniki, 그리스, 54621
- University General Hospital of Thessaloniki (AHEPA)
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Bad Krozingen, 독일, 79189
- Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
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Erlangen, 독일, 91054
- Universitätsklinikum Erlangen
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Homburg, 독일, 66421
- Universitatsklinikum des Saarlandes
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Leipzig, 독일, 04289
- Herzzentrum Leipzig, Universitätsklinik
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Lübeck, 독일, 23560
- Sana Kliniken Lübeck
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Alabama
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Huntsville, Alabama, 미국, 35801
- Heart Center Research, LLC
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California
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Stanford, California, 미국, 94305
- Stanford Hospital and Clinics
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale New Haven Hospital
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20422
- Washington DC VA Medical Center
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Florida
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Jacksonville, Florida, 미국, 32207
- Baptist Medical Center Jacksonville
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Jacksonville, Florida, 미국, 32216
- Memorial Hospital Jacksonville
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Tallahassee, Florida, 미국, 32308
- Tallahassee Research Institute
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, 미국, 30309
- Piedmont Heart Institute
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Iowa
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West Des Moines, Iowa, 미국, 50266
- Iowa Heart Center
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Kentucky
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Lexington, Kentucky, 미국, 40536
- University of Kentucky
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Michigan
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Pontiac, Michigan, 미국, 48341
- St Joseph Mercy Oakland
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Southfield, Michigan, 미국, 48075
- Providence Hospital
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Minnesota
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Minneapolis, Minnesota, 미국, 55407
- Minneapolis Heart Institute Foundation
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Mississippi
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Hattiesburg, Mississippi, 미국, 39401
- Hattiesburg Clinic
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Tupelo, Mississippi, 미국, 38801
- Cardiology Associates Research LLC
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Missouri
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St Louis, Missouri, 미국, 63110
- Barnes-Jewish Hospital
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New Jersey
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Livingston, New Jersey, 미국, 07039
- Saint Barnabas Medical Center
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New York
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Manhasset, New York, 미국, 11030
- North Shore University Hospital
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New York, New York, 미국, 10029
- Mount Sinai Medical Center
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New York, New York, 미국, 10021
- Weill Cornell Medical College/The New York Presbyterian Hospital
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health & Science University Hospital
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Pennsylvania
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Harrisburg, Pennsylvania, 미국, 17011
- PinnacleHealth Cardiovascular Institute
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Philadelphia, Pennsylvania, 미국, 19104
- Hospital of the University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- The Miriam Hospital
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South Carolina
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Anderson, South Carolina, 미국, 29621
- AnMed Health
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Tennessee
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Nashville, Tennessee, 미국, 37203
- Centennial Medical Center
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Texas
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Dallas, Texas, 미국, 75226
- Baylor Heart & Vascular Hospital
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West Virginia
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Charleston, West Virginia, 미국, 25304
- Charleston Area Medical Center
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53215
- Aurora St. Luke's Medical Center
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Galway, 아일랜드
- Galway University Hospital
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Bournemouth, 영국
- Royal Bournemouth Hospital
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Cardiff, 영국
- Cardiff and Vale University Health Board - University Hospital of Wales
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Exeter, 영국, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
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London, 영국, W12 0HS
- Imperial College Healthcare NHS Trust
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Wels, 오스트리아, 4600
- Klinikum Wels-Grieskirchen
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Osaka, 일본
- Saiseikai Nakatsu Hospital
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Hyōgo
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Takarazuka, Hyōgo, 일본
- Higashi Takarazuka Satoh Hospital
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Okamoto
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Kamakura, Okamoto, 일본
- Shonan Kamakura General Hospital
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Tochigi
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Shimotsuke, Tochigi, 일본, 329-0498
- Jichi Medical University Hospital
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Tokyo
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Chiyoda City, Tokyo, 일본, 101-8643
- Mitsui Memorial Hospital
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Ontario
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Hamilton, Ontario, 캐나다
- Hamilton Heath
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Toronto, Ontario, 캐나다
- St. Michael's Hospital
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Toulouse, 프랑스
- Clinique Pasteur
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Kogarah, 호주
- St. George Hospital
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Perth, 호주
- Royal Perth
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Victoria
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Melbourne, Victoria, 호주, 3004
- Alfred Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 개인의 진료실 수축기 혈압(SBP) ≥ 150 mmHg 및
- 개인의 24시간 활동성 혈압 모니터링(ABPM) 평균 SBP ≥ 140 mmHg 및 < 170 mmHg.
제외 기준:
- 개인은 적절한 신장 동맥 해부학이 부족합니다.
- 개인의 예상 사구체 여과율(eGFR)은 다음과 같습니다.
- 개인은 1형 진성 당뇨병 또는 잘 조절되지 않는 2형 진성 당뇨병이 있습니다.
- 개인은 하나 이상의 기립성 저혈압 에피소드가 있습니다.
- 개인은 수면 무호흡증에 대한 야간 호흡 지원 이외의 만성 산소 지원 또는 기계 환기가 필요합니다.
- 개인은 원발성 폐 고혈압이 있습니다.
- 개인이 임신 중이거나 수유 중이거나 임신을 계획 중입니다.
- 개인이 등록 전 한 달 동안 일주일에 2일 이상 비스테로이드성 항염증제(NSAID) 치료를 받는 빈번한 간헐적 또는 만성 통증이 있습니다.
- 개인이 등록 3개월 이내에 안정형 또는 불안정형 협심증, 등록 3개월 이내에 심근 경색증을 앓는 경우; 심부전, 뇌혈관 사고 또는 일과성 허혈성 발작 또는 심방 세동.
- 개인은 야간 근무를 합니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 신장 탈신경
신장 혈관 조영술 및 신장 신경제거(Symplicity Spyral™ 다중 전극 신장 신경제거 시스템)
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표준 절차에 따른 신장 혈관 조영술 후, 피험자는 맹검 상태로 유지되고 무작위 배정 후 즉시 신장 신경 차단 절차로 치료됩니다.
다른 이름들:
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가짜 비교기: 가짜 절차
신장 혈관 조영술
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표준 절차에 따른 신장 혈관 조영술 후 피험자는 눈이 멀고 유도관 제거 전 최소 20분 동안 카테터 삽입 실험실 테이블에 남아 있습니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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24시간 활동 혈압 모니터링(ABPM)으로 측정한 수축기 혈압의 변화
기간: 기준선부터 시술 후 6개월까지
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기준선(2차 선별검사 방문)부터 시술 후 6개월까지 24시간 활동 혈압 모니터링(ABPM)으로 측정한 수축기 혈압(SBP)의 기준선 조정된 변화(공분산 분석 사용).
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기준선부터 시술 후 6개월까지
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Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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고혈압약 복용 및 6개월 단위 변경
기간: 기준선부터 시술 후 6개월까지
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기준선(스크리닝 방문 2)부터 시술 후 6개월까지의 약물 수
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기준선부터 시술 후 6개월까지
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6개월까지 항고혈압제 복용 부담
기간: 기준선부터 시술 후 6개월까지
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보고된 처방 약물을 기반으로 항고혈압제 복용량에 처방된 약물 수를 곱한 복합 지수인 Medication Index 2 점수를 사용하여 약물 부담을 계산했습니다. 모든 계열(ACE/ARB, 칼슘 채널 차단제 등)은 효능이 동등한 것으로 간주되었습니다. 점수가 높을수록 표준 복용량보다 더 높은 복용량이 처방된다는 것을 의미합니다. 최소값 0; 최대값 없음 |
기준선부터 시술 후 6개월까지
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약물 변경
기간: 시술 후 6개월까지의 기준선
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Medication Index 2 약물 검사 데이터를 기반으로 약물 변경이 있었던 환자.
약물 지수 2 점수는 항고혈압제 복용량에 처방된 약물 수를 곱한 복합 지수입니다. 모든 계열(ACE/ARB, 칼슘 채널 차단제 등)은 효능이 동등한 것으로 간주되었습니다.
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시술 후 6개월까지의 기준선
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목표 사무실 수축기 혈압 달성 발생률
기간: 기준선부터 시술 후 6개월까지
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시술 후 6개월에 목표 진료실 수축기 혈압(SBP<140mmHg)에 도달한 빈도.
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기준선부터 시술 후 6개월까지
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Change in Office Systolic Blood Pressure to 6-months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
From baseline to 6 months post-procedure
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Antihypertensive Medication Burden to 36-months
기간: 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
기간: 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
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Antihypertensive Medication Burden to 12-Months
기간: 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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Raymond Townsend, MD, University of Pennsylvania
- 수석 연구원: David Kandzari, MD, Piedmont Hospital
- 수석 연구원: Michael Böhm, MD, Universitätskliniken des Saarlandes
- 수석 연구원: Kazuomi Kario, MD, Jichi Medical University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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최초 제출
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연구 기록 업데이트
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심혈관 질환에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국