Health Trials

ELEVATE-HFpEF Clinical Study

ConditionHeart Failure With Preserved Ejection Fraction (HFpEF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMedtronic Cardiac Rhythm and Heart Failure

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 40 years

Documented EF ≥50% within the preceding 12 months

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

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

Disqualifiers

Improved or recovered EF (i.e., prior LVEF<50%)

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))

Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)

Average heart rate <50 bpm or symptomatic bradycardia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized cardiac pacing

    Device

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

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Personalized Pacing Therapy (Treatment Group)Experimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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.

Time frame
Follow-up duration for endpoint analysis is 12-months.
2

Primary Safety Objective: Percentage of patients with major complications related to the system or procedure.

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.

Time frame
12-months post pacemaker implant attempt.

Secondary outcomes

1

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.

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.

Time frame
Follow-up duration for endpoint analysis is 12-months.
2

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.

NT-proBNP will be collected at baseline and 12-months. The change in NT-proBNP will be compared between treatment and control groups.

Time frame
Follow-up duration for endpoint analysis is 12-months.
3

Secondary Objective #3: Compare AF burden as measured by the device between randomized treatment groups.

AF burden (percentage of time in atrial fibrillation) is collected by the pacemaker system. AF burden will be compared between treatment and control groups.

Time frame
Follow-up duration for endpoint analysis is 12-months.
4

Secondary Objective #4: Compare the change in 6-minute walk distance from baseline to 12-months between randomized treatment groups.

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.

Time frame
Follow-up duration for endpoint analysis is 12-months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Cardiac Rhythm and Heart Failure

Lead sponsor

Source ClinicalTrials.gov
Apply now