Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous coronary intervention
Procedure/SurgeryParticipants 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 procedure
Other interventionParticipant 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.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: PCIActive comparator 1 intervention
Group B: Placebo PCIPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of life measured using KCCQ-OSS
Time frame
At 6 monthsSecondary outcomes
1
All-cause death and hospitalisation for heart failure
Time frame
At 6 months2
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.
Time frame
At discharge from the procedure3
Individual components of the KCCQ (including total symptom score and clinical summary score)
Time frame
At 6 months4
Health status measured using New York Heart Association (NYHA) functional class
Time frame
At 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov