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ELEVATE-HFpEF klinisk undersøgelse (ELEVATE-HFpEF)

1. november 2026 opdateret af: Medtronic Cardiac Rhythm and Heart Failure

Randomiseret forsøg med ELEVATED cardiac pacing rate til personlig behandling af hjertesvigt med bevaret ejektionsfraktion (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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

700

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Personalized cardiac pacing

Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

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)

9. juli 2025

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

14. oktober 2024

Først indsendt, der opfyldte QC-kriterier

5. november 2024

Først opslået (Faktiske)

7. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MDT23039

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

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 .

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