Biomarkers for Left Ventricular Reverse Remodeling in Heart Failure (REVERT-HF) (NCT07701876) | Clinical Trial Compass
RecruitingNot Applicable
Biomarkers for Left Ventricular Reverse Remodeling in Heart Failure (REVERT-HF)
China1,740 participantsStarted 2025-11-01
Plain-language summary
Heart failure is a serious condition where the heart cannot pump blood effectively. Some patients with severe heart failure (known as heart failure with reduced ejection fraction, or HFrEF) can experience significant improvement in their heart function after receiving guideline-directed medical therapy. This phenomenon is called heart failure with improved ejection fraction (HFimpEF). However, it is not fully understood why some patients improve while others do not.
This study aims to explore the molecular mechanisms behind this improvement by collecting blood samples and clinical data from patients with HFrEF in China. Participants will be followed for 12 months, and their heart function will be assessed at multiple time points. By analyzing blood biomarkers and imaging data, researchers hope to identify predictors of heart function improvement and develop a model to help personalize treatment for heart failure patients.
This is an observational study, meaning participants will receive their usual medical care and no experimental treatments or medications will be given. The study involves regular clinical visits and blood draws as part of routine care.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 and ≤ 90 years at the time of signing informed consent.
. Diagnosed with symptomatic chronic heart failure with reduced ejection fraction (NYHA class II-IV) and has been on stable, optimized guideline-directed medical therapy and/or device therapy for at least 4 weeks.
. Left ventricular ejection fraction ≤ 40% assessed by echocardiography or cardiac MRI within 1 month prior to enrollment.
. For patients who have undergone coronary revascularization (PCI or CABG), valve repair/replacement, cardiac resynchronization therapy (CRT), or other treatments that may improve LVEF (e.g., initiation of beta-blockers), LVEF must be reassessed at least 1 month after the intervention before enrollment.
. If multiple LVEF measurements are available, the most recent one will be used for eligibility determination.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to 12 Months
. NT-proBNP level measured at enrollment meeting at least one of the following criteria:
. For LVEF 36%-40%: NT-proBNP ≥ 2500 pg/mL (sinus rhythm) or ≥ 5000 pg/mL (atrial fibrillation).
. For LVEF 31%-35%: NT-proBNP ≥ 1000 pg/mL (sinus rhythm) or ≥ 2000 pg/mL (atrial fibrillation).
Exclusion criteria
. Poor treatment adherence that may lead to worsening heart failure symptoms and signs due to non-compliance with prescribed medication.
. Systolic blood pressure \< 90 mmHg at enrollment or symptomatic hypotension within the past 24 hours.
. Myocardial infarction (defined by elevated cardiac enzymes with ischemic symptoms or new ischemic ECG changes), unstable angina, stroke, or transient ischemic attack (TIA) within 90 days prior to enrollment.
. Coronary revascularization (PCI/CABG) or valve repair/replacement within 1 month prior to enrollment, or planned to undergo such procedures after enrollment.
. CRT implantation within 1 month prior to enrollment, or planned CRT implantation during the study period.
. Prior heart transplantation or ventricular assist device (VAD) implantation, or planned VAD implantation during the study period.
. History of specific cardiomyopathies, including restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (including but not limited to amyloidosis), familial or genetic cardiomyopathy, or arrhythmogenic right ventricular cardiomyopathy.
. Complex congenital heart disease or severe uncorrected primary valvular heart disease.