Heart FailureREVERT-HFNCT07701876
Biomarkers for Left Ventricular Reverse Remodeling in Heart Failure (REVERT-HF)
An observational study of Heart Failure and Heart Failure and Reduced Ejection Fraction, run by Ruijin Hospital Luwan Branch at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Heart Failure and Reduced Ejection Fraction
- How many people
- 1,740 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Aug 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- NT-proBNP level measured at enrollment meeting at least one of the following criteria:
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- 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).
- For LVEF ≤ 30%: NT-proBNP ≥ 600 pg/mL (sinus rhythm) or ≥ 1200 pg/mL (atrial fibrillation).
- For patients rehospitalized for heart failure (LVEF ≤ 40% with heart failure hospitalization within the past 12 months): NT-proBNP ≥ 600 pg/mL (sinus rhythm) or ≥ 1200 pg/mL (atrial fibrillation).
- Receiving standard HFrEF medical therapy, unless contraindicated or intolerant, and stable for at least 4 weeks (excluding diuretic dose adjustments). The regimen should include, if applicable: ACE inhibitor, ARB, or sacubitril/valsartan (ARNI) + beta-blocker + mineralocorticoid receptor antagonist (MRA) + SGLT2 inhibitor. Other agents such as vericiguat may be used with documentation.
- Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m² (CKD-EPI) at enrollment.
- Willing and able to provide signed informed consent and comply with the requirements of the protocol.
Who cannot join
- 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.
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- 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.
- Symptomatic bradycardia or second/third-degree atrioventricular block without a pacemaker.
- Life expectancy < 1 year due to non-cardiovascular causes (including but not limited to malignant tumors).
- Active malignancy or history of malignancy diagnosed within 2 years prior to screening, except for: (a) adequately treated basal cell carcinoma of the skin; (b) carcinoma in situ of the cervix; (c) low-risk prostate cancer (defined as PSA < 10 ng/mL, Gleason score ≤ 6, and clinical stage T1c or T2a prior to treatment).
- Alternative or concomitant diagnoses that could explain the participant's heart failure symptoms and signs (e.g., severe anemia, hypothyroidism, nephrotic syndrome).
- Primary pulmonary hypertension, chronic pulmonary embolism, or severe pulmonary disease (including COPD requiring home oxygen or frequent hospitalizations, or COPD exacerbation requiring invasive mechanical ventilation within 12 months prior to enrollment).
- Hepatic impairment: total bilirubin ≥ 1.5 × upper limit of normal (ULN), or ALT/AST ≥ 3 × ULN (patients with Gilbert's syndrome and unconjugated hyperbilirubinemia with total bilirubin ≥ 1.5 × ULN but without other evidence of hepatic impairment may be enrolled).
- Known blood-borne infectious diseases.
- Severe or unstable kidney disease: eGFR < 20 mL/min/1.73 m² (CKD-EPI) at randomization, rapidly deteriorating renal function, or requiring renal replacement therapy.
- Systolic blood pressure ≥ 160 mmHg (if on < 3 antihypertensive agents) or ≥ 180 mmHg (regardless of treatment) at enrollment.
- Hemoglobin level < 9 g/dL.
- Major surgery (as judged by the investigator) within 90 days prior to enrollment, or planned major elective surgery within 90 days after screening.
- Paroxysmal or permanent atrial fibrillation excluded only if:
- Requiring cardioversion (e.g., electrical cardioversion, atrial fibrillation ablation, or antiarrhythmic therapy) within ≤ 3 months prior to screening.
- Heart rate not adequately controlled with anticoagulation therapy for at least 3 months prior to screening.
- Participation in another clinical trial and use of an investigational drug within 1 month prior to enrollment.
- Any other clinically significant disease, malignancy, active infection, condition, or disorder that, in the opinion of the investigator or medical monitor, may pose a safety risk to the participant or interfere with the evaluation, procedures, or completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Jiayu Bu, +86 13661583416, 2582313099@qq.com
About this study
Official title: A Cohort Study of Advanced Heart Failure Based on Molecular Typing and Imaging Markers
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.
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFimpEF | Not described | |
| Persistent HFrEF | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to 12 Months
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Nov 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,740 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital Luwan Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bu Jiayu, Ruijin Hospital Luwan Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701876
- Sponsor's protocol ID
- 202540150
- Acronym
- REVERT-HF
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Advanced Heart Failure Based on Molecular Typing and Imaging Markers
- ClinicalTrials.gov ID
- NCT07701876
- Acronym / sponsor ID
- REVERT-HF / 202540150
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,740 participants (estimated)
- Lead sponsor
- Ruijin Hospital Luwan BranchUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFimpEF | – | – |
| Persistent HFrEF | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (13 listed)
- 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.
- NT-proBNP level measured at enrollment meeting at least one of the following criteria:
- Receiving standard HFrEF medical therapy, unless contraindicated or intolerant, and stable for at least 4 weeks (excluding diuretic dose adjustments). The regimen should include, if applicable: ACE inhibitor, ARB, or sacubitril/valsartan (ARNI) + beta-blocker + mineralocorticoid receptor antagonist (MRA) + SGLT2 inhibitor. Other agents such as vericiguat may be used with documentation.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to 12 Months
Time frame: Baseline and 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure and Reduced Ejection Fraction, run by Ruijin Hospital Luwan Branch at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to 12 Months (time frame: Baseline and 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.