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New treatment option for Heart Failure With Preserved Ejection Fraction (HFpEF)
Official title ELEVATE-HFpEF Clinical Study
ClinicalTrials.gov ID: NCT06678841
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Age ≥ 40 years
- Documented EF ≥50% within the preceding 12 months
- HFpEF defined as:
- Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months...
- Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
You likely can't join if
- 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...
- Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
- Average heart rate \<50 bpm or symptomatic bradycardia
- Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to...
- Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
See the full eligibility criteria
- Age ≥ 40 years
- Documented EF ≥50% within the preceding 12 months
- HFpEF defined as:
- 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
- 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...
- 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
- Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
- 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...
- Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).
- 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...
- Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
- Average heart rate \<50 bpm or symptomatic bradycardia
- 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.
- Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
- Severe obesity defined as BMI \>45.
- Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds
- Planned AF ablation
- Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
- Hypertrophic cardiomyopathies
- Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
- End Stage Renal Disease (CKD 4 or greater)
- More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
- Significant primary pulmonary disease on home oxygen
- Known contraindication for a pacemaker implant
- Advanced co-morbidity with life expectancy \< 1 year
- 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...
- Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Hartford, Connecticut, United States
- Panama City, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Houma, Louisiana, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Lancaster, Pennsylvania, United States
- Wynnewood, Pennsylvania, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
+ 24 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; San Francisco, California, United States; Hartford, Connecticut, United States; Panama City, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.