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New treatment option for Heart Failure With Preserved Ejection Fraction (HFPEF)
Official title Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT07560436
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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: i. Invasively measured left ventricular end diastolic...
You likely can't join if
- 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 treatment study which may affect study outcomes
See the full eligibility criteria
- 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: i. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or...
- 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 treatment study which may affect study outcomes
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.