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Studio clinico ELEVATE-HFpEF (ELEVATE-HFpEF)

1 novembre 2026 aggiornato da: Medtronic Cardiac Rhythm and Heart Failure

Studio randomizzato sulla frequenza di stimolazione cardiaca ELEVATE per il trattamento personalizzato dell'insufficienza cardiaca con frazione di eiezione preservata (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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

700

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: Personalized cardiac pacing

Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 luglio 2025

Completamento primario (Stimato)

1 agosto 2028

Completamento dello studio (Stimato)

1 febbraio 2029

Date di iscrizione allo studio

Primo inviato

14 ottobre 2024

Primo inviato che soddisfa i criteri di controllo qualità

5 novembre 2024

Primo Inserito (Effettivo)

7 novembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 novembre 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MDT23039

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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