Biomarkers for Left Ventricular Reverse Remodeling in Heart Failure (REVERT-HF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorRuijin Hospital Luwan Branch
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
This study will enroll adult patients (≥18 to ≤90 years of age) with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), defined as NYHA class II-IV and left ventricular ejection fraction ≤40% within 1 month prior to enrollment. Participants must be on stable, optimized guideline-directed medical therapy for at least 4 weeks and meet specified NT-proBNP thresholds. Patients will be recruited from the cardiology departments and outpatient clinics of participating heart failure centers across China. Individuals with poor adherence, severe comorbidities, or other conditions that may interfere with study procedures or pose safety risks will be excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,740 Participants
are grouped into 2 trial groupsGroup A: HFimpEF
Group B: Persistent HFrEF
Trial outcomes
Primary outcomes
1
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to 12 Months
Time frame
Baseline and 12 MonthsSponsors and contacts
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Source ClinicalTrials.gov