Heart Stents for Heart Failure with Preserved Ejection Fraction
Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction
Recruiting
Phase 2Interventional Study
Heart Failure With Preserved Ejection Fraction (HFPEF)Coronary Artery Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
King's College London · Other
Who this trial is looking for
This trial is looking for people with heart failure and narrowed heart arteries. Participants will receive either a heart stent or a placebo procedure that feels the same but does not include a stent.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with heart failure with preserved ejection fraction (HFpEF)
I have symptoms of heart failure as defined by the New York Heart Association
I have a left ventricular ejection fraction of 50% or higher
I have an NT-pro-BNP level over 125 pg/ml in sinus rhythm
I have at least one sign of left ventricular diastolic dysfunction
You may not be able to join if
I am under 18 years old
I cannot provide informed consent
Having a stent is not possible for me
I have a contraindication to taking clopidogrel or dual antiplatelet therapy
I have had a heart attack or coronary surgery in the last 90 days
I have severe chronic obstructive pulmonary disease
My hemoglobin level is 80 g/L or lower
I have another heart condition causing my symptoms
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Status
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 \> …
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)
Contacts
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