NCT07560436 Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction
| NCT ID | NCT07560436 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | King's College London |
| Condition | Heart Failure With Preserved Ejection Fraction (HFPEF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 350 participants in total. It began in 2026-03-23 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly. People living with HFpEF also often have coronary artery disease, where the blood vessels that supply the heart are narrowed or blocked. It is not yet know whether opening these arteries with stents improves symptoms or quality of life with HFpEF. REPRIEVED is a randomised clinical trial that aims to find out if heart stents can improve quality of life for people living with heart failure with preserved ejection fraction (HFpEF) and coronary artery disease. Researchers will compare two groups of people; those who have a stent procedure to those who have a placebo procedure. The placebo procedure feels the same as a stent procedure but does not include a stent. 350 people with HFpEF and coronary artery disease will be asked to take part. Participants will be monitored over a period of 6 months to see if and how quality of life changes. Before the procedure, participants will be asked to complete a short health questionnaire, have a blood test, undergo an electrocardiogram (heart tracing) and scans of their heart. On the day of the procedure, the participant will come to the hospital for an angiogram and will be randomly allocated to have either treatment with a stent or the placebo procedure without a stent. Participants will not know whether they have received heart stents. This helps researchers know that any improvements in their quality of life are not just related to how they feel about the stenting treatment. Participants will then be contacted by a member of the research team at 3 months and 6 months after their procedure. At 3 months, participants will complete a short health questionnaire either by phone or during a hospital visit. At 6 months, participants will attend the hospital to complete a short health questionnaire, have blood tests, a scan of the heart (echocardiogram) and an electrocardiogram (heart tracing) to measure any changes in the heart. Participants will be told whether they received the stent procedure or the placebo procedure.
Eligibility Criteria
Inclusion Criteria: 1\. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as: 1. Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and 2. Left ventricular ejection fraction ≥ 50% and 3. NT-pro-BNP \> 125 pg/ml in sinus rhythm or \> 365 pg/ml in atrial fibrillation and 4. One or more of the following objective signs of left ventricular diastolic dysfunction: i. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) ii. Estimated pulmonary artery systolic pressure \> 35mmHg or tricuspid regurgitation velocity \> 2.8 m/s on echocardiography iii. Left atrial volume index \> 34ml/m2 in patient in sinus rhythm or left atrial volume index \> 40ml/m2 in atrial fibrillation iv. Relative left ventricular wall thickness \> 0.42 v. Left ventricular mass index ≥ 95 g/m2 in females or ≥ 115 g/m2 in males vi. Mitral E/E' ratio \> 9 Exclusion Criteria: 1. Age \<18 years 2. People without capacity to provide informed consent 3. PCI contraindicated or not feasible on coronary angiography or screening CTCA 4. Contraindication to clopidogrel/dual antiplatelet therapy 5. Recent acute myocardial infarction or coronary revascularisation (within 90 days) 6. Enrolment in another interventional study which may affect study outcomes 7. Severe chronic obstructive pulmonary disease (GOLD stage ≥3) 8. Haemoglobin \<=80 g/L 9. Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)
Frequently Asked Questions
Who can join the NCT07560436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Preserved Ejection Fraction (HFPEF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07560436 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07560436 currently recruiting?
Yes, NCT07560436 is actively recruiting participants. Visit ClinicalTrials.gov or contact King's College London to inquire about joining.
Where is the NCT07560436 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07560436 clinical trial?
NCT07560436 is sponsored by King's College London. The trial plans to enroll 350 participants.
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