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ELEVATE-HFpEF 임상 연구 (ELEVATE-HFpEF)

2026년 11월 1일 업데이트: Medtronic Cardiac Rhythm and Heart Failure

박출률 보존을 이용한 심부전의 맞춤형 치료를 위한 향상된 심장 조율 속도의 무작위 시험(ELEVATE-HFpEF)

ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group).

Subjects will complete 2-month, 6-month, and 12-month visits where data will be collected. At the 12-month visit, the second group (control group) will also be programmed to their personalized cardiac pacing rate. Subjects will complete 14-month, 18-month, and 24-month visits where data will be collected. Following the 24-month visit, additional long-term follow-up visits will occur annually until study completion. The estimated study duration is approximately 4.5 years representing an estimated 24-month enrollment period and 18-month follow-up period.

연구 유형

중재적

등록 (추정된)

700

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 노르웨이
      • Oslo, 노르웨이, 0372
        • 모병
        • Oslo Universitetssykehus-Rikshospitalet
  • 독일
      • Lübeck, 독일, 23538
        • 모병
        • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
  • 말레이시아
      • Kota Samarahan, 말레이시아, 94300
        • 모병
        • Sarawak Heart Centre
      • Kuala Lumpur, 말레이시아, 50400
        • 모병
        • Institut Jantung Negara - National Heart Institute
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • 모병
        • Banner - University Medical Center Phoenix
    • California
      • Palo Alto, California, 미국, 94304
        • 모병
        • Stanford University
      • San Francisco, California, 미국, 94107
        • 모병
        • Sutter Health Hospital
    • Connecticut
      • Hartford, Connecticut, 미국, 06106
        • 모병
        • Hartford Hospital
    • Florida
      • Panama City, Florida, 미국, 32405
        • 모병
        • Cardiovascular Institute of Northwest Florida
    • Georgia
      • Atlanta, Georgia, 미국, 30308
        • 모병
        • Emory University
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • 모병
        • The University of Chicago Medical Center
    • Iowa
      • Des Moines, Iowa, 미국, 50266
        • 빼는
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • 모병
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, 미국, 40295
        • 모병
        • Norton Healthcare
    • Louisiana
      • Houma, Louisiana, 미국, 70360
        • 빼는
        • Cardiovascular Institute of the South
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • 모병
        • Tufts Medical Center
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • 모병
        • M Health Fairview University of Minnesota Medical Center - East Bank
    • Missouri
      • Kansas City, Missouri, 미국, 64111
        • 모병
        • Saint Lukes Mid America Heart Institute
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87106
        • 모병
        • Presbyterian Heart Group
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • 모병
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • 모병
        • The Ohio State University Wexner Medical Center
      • Columbus, Ohio, 미국, 43219
        • 모병
        • Mount Carmel East
    • Pennsylvania
      • Lancaster, Pennsylvania, 미국, 17602
        • 모병
        • Lancaster General Hospital
      • Wynnewood, Pennsylvania, 미국, 19096
        • 모병
        • Lankenau Institute for Medical Research
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • 모병
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • Saint Thomas Research Institute
    • Texas
      • Dallas, Texas, 미국, 75216
        • 모병
        • Dallas VA Medical Center
      • Fort Worth, Texas, 미국, 76104
        • 모병
        • Texas Health Research & Education Institute
      • Plano, Texas, 미국, 75093
        • 모병
        • Baylor Research Institute
    • Vermont
      • Burlington, Vermont, 미국, 05401
        • 모병
        • The University of Vermont Medical Center
    • Virginia
      • Falls Church, Virginia, 미국, 22042
        • 모병
        • Inova Fairfax Hospital
    • Washington
      • Tacoma, Washington, 미국, 98405
        • 모병
        • Saint Joseph Medical Center (Tacoma WA)
    • West Virginia
      • Charleston, West Virginia, 미국, 25304
        • 모병
        • Charleston Area Medical Center (CAMC) Memorial Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
        • 모병
        • Froedtert Hospital
  • 벨기에
      • Edegem, 벨기에, 2650
        • 모병
        • Universitair Ziekenhuis Antwerpen
  • 스위스
      • Geneva, 스위스, 1205
        • 모병
        • Hôpitaux Universitaires de Genève
  • 슬로베니아
      • Ljubljana, 슬로베니아, 1000
        • 모병
        • University Medical Centre Ljubljana
  • 영국
      • Leeds, 영국, LS1 3EX
        • 모병
        • The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
      • London, 영국, SE1 7EH
        • 모병
        • Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital
      • Manchester, 영국, M13 9WL
        • 모병
        • Manchester University NHS Foundation Trust - Manchester Royal Infirmary
  • 오스트리아
      • Linz, 오스트리아, 4010
        • 모병
        • Ordensklinikum Linz GmbH / Elisabethinen
  • 일본
    • Chiba
      • Chiba, Chiba, 일본, 260-8677
        • 모병
        • Chiba University Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, 일본, 802-8555
        • 모병
        • Kokura Memorial Hospital
    • Osaka
      • Suita, Osaka, 일본, 564-8565
        • 모병
        • National Cerebral and Cardiovascular Center
  • 체코
      • Prague, 체코, 100 34
        • 모병
        • Fakultni nemocnice Královské Vinohrady
  • 캐나다
      • Calgary, 캐나다, T2N 2T9
        • 모병
        • University of Calgary
      • Vancouver, 캐나다, V6Z 1Y6
        • 모병
        • Saint Pauls Hospital
  • 프랑스
      • Besançon, 프랑스, 25030
        • 모병
        • Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
      • Clermont-Ferrand, 프랑스, 63003
        • 모병
        • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
      • Nantes, 프랑스, 44093
        • 모병
        • Hôpital Guillaume et René Laënnec - CHU de Nantes
      • Toulouse, 프랑스, 50032
        • 모병
        • CHU Toulouse - Hôpital Rangueil
  • 호주
    • Queensland
      • Chermside, Queensland, 호주, 4032
        • 모병
        • The Prince Charles Hospital
    • Victoria
      • Melbourne, Victoria, 호주, 3004
        • 모병
        • The Alfred Hospital
  • 홍콩
      • Hong Kong, 홍콩
        • 모병
        • Prince of Wales Hospital
      • Hong Kong, 홍콩
        • 모병
        • Queen Elizabeth Hospital (Hong Kong)

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age ≥ 40 years

  2. Documented EF ≥50% within the preceding 12 months

  3. HFpEF defined as:

    1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR

    2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:

      • Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure

      • Elevated NT-proBNP in the last year defined as >400 pg/m for patients with no AF or paroxysmal AF, or >900 pg/ml for patients with ≥persistent AF

      • Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)

      • Echo criteria defined by ≥2 of:

        • LV wall thickness ≥ 12 mm
        • LV mass index (BSA indexed LVH): sex at birth male >115 g/m2, sex at birth female >95 g/m2
        • Relative wall thickness ≥0.42
        • E/e' ≥15 in sinus rhythm (or > 11 in the setting of atrial fibrillation) OR septal <7 cm/s or lateral e' <10cm/s
        • Tricuspid regurgitation (TR) velocity >2.8 m/s
        • Left atrial (LA) enlargement, defined by LA volume index >34 ml/m2

  4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days

  5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)

  6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).

Exclusion Criteria:

  1. Improved or recovered EF (i.e., prior LVEF<50%)
  2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))
  3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
  4. Average heart rate <50 bpm or symptomatic bradycardia
  5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.
  6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
  7. Severe obesity defined as BMI >45.
  8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate <50 bpm or evidence of ventricular pauses exceeding 6 seconds
  9. Planned AF ablation
  10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
  11. Hypertrophic cardiomyopathies
  12. Uncontrolled hypertension as defined by BP >160/100 mmHg on two measurements ≥15 minutes apart
  13. End Stage Renal Disease (CKD 4 or greater)
  14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
  15. Significant primary pulmonary disease on home oxygen
  16. Known contraindication for a pacemaker implant
  17. Advanced co-morbidity with life expectancy < 1 year
  18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.
  19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Personalized Pacing Therapy (Treatment Group)

The treatment group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide dual chamber pacing at a personalized cardiac pacing rate determined by patient height and baseline LVEF percentage.
장치: Personalized cardiac pacing

Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
간섭 없음: Control Group

The control group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide ventricular pacing at a non-personalized rate. This is considered limited or backup pacing.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary Efficacy Objective: Hierarchical composite endpoint of cardiovascular mortality, urgent HF events, HF events requiring an oral diuretic intensification (ODI), change in KCCQ, change in six-minute walk test distance, and change in NT-proBNP.
기간: Follow-up duration for endpoint analysis is 12-months.

Cardiovascular mortality, urgent heart failure events, and ODI heart failure events will be collected as they occur. The Kansas City Cardiomyopathy Questionnaire (KCCQ); (range of score is 0 to 100), 6-minute walk test (distance in meters), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) (picograms per milliliter, pg/mL) will be collected at Baseline and the 12-months visit. Treatment and control groups will be compared using a win ratio.
Follow-up duration for endpoint analysis is 12-months.
Primary Safety Objective: Percentage of patients with major complications related to the system or procedure.
기간: 12-months post pacemaker implant attempt.

Adverse events will be collected as they occur. Adverse events will be adjudicated for their relationship to the implant procedure and system. Severity of adverse events related to the procedure or system will be reviewed to determine if they are major complications. Major complications are defined as complications related to the system or procedure that result in one or more of the following: death, hospitalization, prolonged hospitalization by at least 48 hours, additional surgical intervention, system modification (e.g., reposition, replacement, or explant), and/or permanent loss of device function due to mechanical or electrical dysfunction of the device. The percentage of patients undergoing a pacemaker implant attempt who experience a major complication related to the system or procedure at 12 months.
12-months post pacemaker implant attempt.

2차 결과 측정

결과 측정
측정값 설명
기간
Secondary Objective #1: Compare changes in HF-related health status as measured by the KCCQ-CSS from baseline to 12-months between randomized treatment groups.
기간: Follow-up duration for endpoint analysis is 12-months.

KCCQ will be collected at baseline and 12-months and the clinical summary score (CSS) will be computed with a range of 0 to 100, 100 being the best score. The change in KCCQ-CCS will be compared between the treatment and control groups.
Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #2: Compare the change in NT-proBNP from baseline to 12-months between randomized groups by comparing NT-proBNP measured at baseline and 12-months.
기간: Follow-up duration for endpoint analysis is 12-months.

NT-proBNP will be collected at baseline and 12-months. The change in NT-proBNP will be compared between treatment and control groups.
Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #3: Compare AF burden as measured by the device between randomized treatment groups.
기간: Follow-up duration for endpoint analysis is 12-months.

AF burden (percentage of time in atrial fibrillation) is collected by the pacemaker system. AF burden will be compared between treatment and control groups.
Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #4: Compare the change in 6-minute walk distance from baseline to 12-months between randomized treatment groups.
기간: Follow-up duration for endpoint analysis is 12-months.

The 6-minute walk test will be performed at baseline and 12-months. The change in walk test distance (in meters) from baseline to 12-months will be compared between the treatment and control groups.
Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #5: Compare device measured physical activity between randomized treatment groups during the 12-month follow-up period.
기간: Follow-up duration for endpoint analysis is 12-months.

Physical activity (hours per day) is collected by the pacemaker system. The average physical activity during the 12-month follow-up period will be compared between the treatment and control group.
Follow-up duration for endpoint analysis is 12-months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Medtronic Cardiac Rhythm and Heart Failure

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 9일

기본 완료 (추정된)

2028년 8월 1일

연구 완료 (추정된)

2029년 2월 1일

연구 등록 날짜

최초 제출

2024년 10월 14일

QC 기준을 충족하는 최초 제출

2024년 11월 5일

처음 게시됨 (실제)

2024년 11월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 1일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MDT23039

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다