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Stents plus drugs vs. drugs alone: which is better for heart failure?

NCT ID NCT07349979

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two approaches for people with heart failure and narrowed heart arteries: a stent procedure plus guideline-directed medications versus medications alone. About 1,150 participants will be followed for at least two years to see which group has fewer major heart problems like heart attacks, hospitalizations, or death. The goal is to find out if adding a stent improves outcomes beyond what medications can achieve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
heart stent procedure (percutaneous coronary intervention) plus standard heart failure medications
What this could lead to
If it works, this could show that combining stents with medications is better than medications alone for preventing heart attacks, hospitalizations, and death in people with heart failure.
What could go wrong
This trial hasn't started yet, so results are years away. The procedure carries risks like bleeding or vessel damage, and the benefit over medications alone may be small or absent.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,154 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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. Age ≥18 years at screening. 2. Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization. 3. Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg/mL. 4. Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (\>80%) of PCI success, or 3) a visually estimated DS of \<90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist. 5. On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site. 6. The subject, or their legal guardian, has a clear understanding of the trial's design and procedures, provide written informed consent, and is able to comply with all follow-up procedures. Exclusion Criteria: 1. Class III or IV angina requiring revascularization. 2. Any unplanned hospitalization within 30 days. 3. Any PCI within 12 months. 4. Any prior CABG. 5. Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate) 6. Non-cardiac life expectancy \<1 year at screening (e.g., malignancy, advanced liver disease). 7. Coronary anatomy requiring surgical revascularization by local heart team determination. 8. Coronary anatomy unsuitable for PCI. 9. HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM). 10. Severe stenosis or regurgitation of any heart valve. 11. Contraindication to dual antiplatelet therapy or iodinated contrast. 12. Pregnancy, lactation, or women of childbearing potential not using effective contraception. A negative urine pregnancy test is required within 7 days prior to randomization for women of childbearing potential. 13. Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol. 14. Any other circumstances that the investigator deems inappropriate for participation, including but not limited to conditions that may jeopardize patient safety, confound data interpretation, or patients unlikely to comply with study procedures.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu, 210006, China

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