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Heart biopsy study aims to unlock secrets of heart failure

NCT ID NCT06517186

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 heart tissue from 180 people with a type of heart failure called HFpEF. Researchers take tiny samples of heart muscle during a routine procedure to find changes in the tissue. The goal is to learn what causes this condition so better treatments can be developed.

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.

Participants

About 180 people

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

Started

Nov 2024

Expected to finish

Dec 2026

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.

Who is studied

Adults over 30 years of age.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * HFpEF criteria 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability) 3. Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following: 1. Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrial fibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center. 2. Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels \[using the thresholds listed above\], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography). 3. Previously documented elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP/cardiac output ratio ≥2 mmHg/L/min for upright exercise). 4. Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5). Suspected HFpEF criteria 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability) 3. Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following: 1. Does not meet BNP or NT-proBNP criteria for HFpEF (above) 2. No prior HF hospitalization meeting HF criteria (above) 3. No previous hemodynamic catheterization documentation of HF (as above) Exclusion Criteria: * 1\. Inadequate echo or fluoroscopic images. 2\. Neck anatomy unfavorable for jugular venous cannulation 3\. Therapy with direct oral anticoagulants without cessation for a period (age, renal function, and agent specific) deemed adequate to normalize coagulation according to local clinical guidelines. 4\. Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB 5\. Platelet count \< 50,000/ml 6\. Active bleeding or coagulation disorder 7\. Infection or fever 8\. Endocarditis 9\. Pregnancy 10\. Intracardiac thrombus 11\. RV Aneurysm 12\. Clinically significant tricuspid, pulmonary or aortic valve stenosis 13\. Tricuspid or pulmonary mechanical valve prosthesis 14\. Left bundle branch block

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Mass General Brigham

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Wake Forest University

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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