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Heart stent study aims to ease stiff heart symptoms

NCT ID NCT07560436

Symptom relief Sponsor: King's College London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether placing stents in blocked heart arteries can improve quality of life for people with heart failure with preserved ejection fraction (HFpEF), a condition where the heart muscle is stiff. About 350 participants will be randomly assigned to receive either a real stent or a placebo procedure, and neither they nor their doctors will know which they got. The main goal is to see if stents lead to better daily living and fewer symptoms over 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

coronary artery disorder diastolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Heart failure with preserved ejection fraction (hfpef)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guy's & St Thomas' NHS Foundation Trust

    RECRUITING

    London, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.