Heart Failure With Preserved Ejection Fraction (HFPEF)Phase 2REPRIEVEDNCT07560436
Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing Percutaneous coronary intervention in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Coronary Artery Disease, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF), Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2026to Aug 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- Age <18 years
- People without capacity to provide informed consent
- PCI contraindicated or not feasible on coronary angiography or screening CTCA
- Contraindication to clopidogrel/dual antiplatelet therapy
- Recent acute myocardial infarction or coronary revascularisation (within 90 days)
- Enrolment in another interventional study which may affect study outcomes
Show all 9Show fewer
- Severe chronic obstructive pulmonary disease (GOLD stage ≥3)
- Haemoglobin <=80 g/L
- Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' NHS Foundation Trust
London
Matthew Ryan, +442071881041, matthew.ryan@kcl.ac.uk
About this study
Official title: REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description
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.
Read more
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.
- Being tested
- Percutaneous coronary intervention, Placebo procedure
- Keywords
- HFpEF, Heart failure with preserved ejection fraction, REPRIEVED, REPRIEVED trial, Placebo PCI, CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Participants will receive percutaneous coronary intervention (PCI) as per current standard of care. Angioplasty and stenting will be attempted to all significant coronary stenoses as determined by the CT-FFR or FFR measurements. Contemporary best practice including the use of intracoronary imaging is mandated. The default approach will be to implant drug eluting stents, but drug coated balloon angioplasty is permitted in selected cases in accordance with the current evidence base and guidelines. Operators will achieve as much revascularisation as can safely be delivered in a timeframe which maintains blinding; if incomplete revascularisation is necessary, operators will target treatment to the most haemodynamically significant lesions subtending the largest territories. Staged procedures are not permitted.
Placebo procedureOther
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. Movements of the image intensifier, screen display and personnel will simulate a PCI procedure.
| Study group | Role | What they receive |
|---|---|---|
| PCI | Active comparator | Not described Receives: Procedure: Percutaneous coronary intervention |
| Placebo PCI | Placebo comparator | Participants will undergo a placebo stent procedure that involves placement of a catheter but no actual stent. Participants randomised to the placebo procedure will receive matching placebo clopidogrel capsules, to be taken for up to 6 months after the procedure. Receives: Other: Placebo procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured using KCCQ-OSS
Measured: At 6 months
Secondary outcomes (7)
All-cause death and hospitalisation for heart failure
Measured: At 6 months
Efficacy of blinding assessed using the blinding index
The blinding index is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.
Measured: At discharge from the procedure
Individual components of the KCCQ (including total symptom score and clinical summary score)
Measured: At 6 months
Health status measured using New York Heart Association (NYHA) functional class
Measured: At 6 months
NT-pro-BNP measured using blood test/assay
Measured: At 6 months
Difference in left ventricular ejection fraction (LVEF)
Measured: At 6 months
Difference in diastolic function (mitral E/e')
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start23 Mar 2026
- Primary completionNov 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560436
- Sponsor's protocol ID
- IRAS ID 330189
- Other IDs
- NIHR159715, 12843546
- Acronym
- REPRIEVED
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description
- ClinicalTrials.gov ID
- NCT07560436
- Acronym / sponsor ID
- REPRIEVED / IRAS ID 330189
- Keywords
- HFpEF, Heart failure with preserved ejection fraction, REPRIEVED, REPRIEVED trial, Placebo PCI, CAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 1 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI | Active comparator | Procedure: Percutaneous coronary intervention |
| Placebo PCI | Placebo comparator | Other: Placebo procedureParticipants will undergo a placebo stent procedure that involves placement of a catheter but no actual stent. Participants randomised to the placebo procedure will receive matching placebo clopidogrel capsules, to be taken for up to 6 months after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (9 listed)
- Age <18 years
- People without capacity to provide informed consent
- PCI contraindicated or not feasible on coronary angiography or screening CTCA
- Contraindication to clopidogrel/dual antiplatelet therapy
- Recent acute myocardial infarction or coronary revascularisation (within 90 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionParticipants will receive percutaneous coronary intervention (PCI) as per current standard of care. Angioplasty and stenting will be attempted to all significant coronary stenoses as determined by the CT-FFR or FFR measurements. Contemporary best practice including the use of intracoronary imaging is mandated. The default approach will be to implant drug eluting stents, but drug coated balloon angioplasty is permitted in selected cases in accordance with the current evidence base and guidelines. Operators will achieve as much revascularisation as can safely be delivered in a timeframe which maintains blinding; if incomplete revascularisation is necessary, operators will target treatment to the most haemodynamically significant lesions subtending the largest territories. Staged procedures are not permitted. | Procedure or surgery | PCI |
| Placebo procedureParticipant 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. Movements of the image intensifier, screen display and personnel will simulate a PCI procedure. | Other | Placebo PCI |
Primary outcome
Quality of life measured using KCCQ-OSS
Time frame: At 6 months
7 secondary outcomes
All-cause death and hospitalisation for heart failure
Time frame: At 6 months
Efficacy of blinding assessed using the blinding index
Time frame: At discharge from the procedure
Individual components of the KCCQ (including total symptom score and clinical summary score)
Time frame: At 6 months
Health status measured using New York Heart Association (NYHA) functional class
Time frame: At 6 months
NT-pro-BNP measured using blood test/assay
Time frame: At 6 months
Difference in left ventricular ejection fraction (LVEF)
Time frame: At 6 months
Difference in diastolic function (mitral E/e')
Time frame: At 6 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 1 May 2026.
- REPRIEVED trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Percutaneous coronary intervention in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Coronary Artery Disease, run by King's College London at 1 site in United Kingdom.
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 6 inclusion and 9 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 1 May 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of life measured using KCCQ-OSS (time frame: At 6 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 1 May 2026.