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Looking for participantsPhase2

Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction

Sponsor: King's College London

NCT ID: NCT07560436

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Percutaneous coronary intervention (procedure), Placebo procedure (other)
How long the study runs
Study runs about 41 months (dates as stated)
About the drug or intervention
Percutaneous coronary intervention — procedure: Participants will receive percutaneous coronary intervention (PCI) as per current standard of care. · Placebo procedure — other: Participant will undergo a placebo PCI procedure that involves placement of a thin tube to image the blood vessel but does not involve placement of an actual stent.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
350
Started
2026-03-23
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure with preserved ejection fraction (hfpef)
  • • Phase2 - 350 participants
  • • HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure with preserved ejection fraction (hfpef)

Where?

  • • London - Guy's & St Thomas' NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Heart Failure With Preserved Ejection Fraction (HFPEF)Coronary Artery Disease

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓1\. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as:
  • ✓Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and
  • ✓Left ventricular ejection fraction ≥ 50% and
  • ✓NT-pro-BNP \> 125 pg/ml in sinus rhythm or \> 365 pg/ml in atrial fibrillation and
  • ✓One or more of the following objective signs of left ventricular diastolic dysfunction:

Who cannot take part

  • ✗Age \<18 years
  • ✗People without capacity to provide agreement to take part
  • ✗PCI not safe to use or not feasible on coronary angiography or screening CTCA
  • ✗safety concern to clopidogrel/dual antiplatelet therapy
  • ✗Recent acute myocardial infarction or coronary revascularisation (within 90 days)
See the full 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)

Where Is This Study? (1 UK site)

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Recruiting
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Data sourced from ClinicalTrials.gov · Last verified: 2026-04