Heart FailureNCT06517186
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Northwestern University at 6 sites in United States.
Trial summary
The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Heart Failure With Preserved Ejection Fraction
- How many people
- 180 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Nov 2024to Dec 2027
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults over 30 years of age.
Who may be able to join
- HFpEF criteria
- Age ≥30 years.
- Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
- Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:
- 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.
- 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).
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- 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).
- Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5).
- Suspected HFpEF criteria
- Age ≥30 years.
- Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
- Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:
- Does not meet BNP or NT-proBNP criteria for HFpEF (above)
- No prior HF hospitalization meeting HF criteria (above)
- No previous hemodynamic catheterization documentation of HF (as above)
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Matt Kauffman, mkkauffman@jhmi.edu
Kavita Sharma, MD
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02114
Diane Cocca-Spofford, 617-726-8228, dcoccaspofford@mgh.harvard.edu
Greg Lewis, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Laura Alagna, 312-695-6765, laura.alagna@northwestern.edu
Sadiya Khan, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Tiffany Sharkoski, 215-615-2354
Julio Chirinos, MD, PhD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Brendon Urena, 507-538-8305, urena.brendon@mayo.edu
Margaret Redfield, MD
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27157
Ben Nelson, 336-716-6789
Dalane Kitzman, MD
About this study
Official title: Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study
The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF | Participants with HFpEF | |
| Non-HFpEF | Participants without HFpEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start8 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital, Brigham and Women's Hospital, Mayo Clinic, Wake Forest University Health Sciences, University of Pennsylvania
- Responsible party
- Principal investigator, Sanjiv Shah, Northwestern University
- Investigators
- Sanjiv Shah, MD, Principal investigator, Northwestern UniversityMargaret Redfield, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517186
- Sponsor's protocol ID
- 24-000688
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study
- ClinicalTrials.gov ID
- NCT06517186
- Acronym / sponsor ID
- 24-000688
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital, Brigham and Women's Hospital, Mayo Clinic, Wake Forest University Health Sciences, University of Pennsylvania
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | –Participants with HFpEF |
| Non-HFpEF | – | –Participants without HFpEF |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 30 years of age.
Key inclusion criteria (15 listed)
- HFpEF criteria
- Suspected HFpEF criteria
- Age ≥30 years.
- Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
- Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjiv Shah, MD principal investigator
Northwestern University
Margaret Redfield, MD principal investigator
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Northwestern University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Alagna (312-695-6765, heartsharestudy@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.