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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Massachusetts General Hospital | OTHER |
| Brigham and Women's Hospital | OTHER |
| Mayo Clinic |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFpEF | Participants with HFpEF | ||
| Non-HFpEF | Participants without HFpEF |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF) | Up to 5 years |
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Inclusion Criteria:
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:
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:
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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Adults over 30 years of age.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Alagna | Contact | 312-695-6765 | heartsharestudy@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sanjiv Shah, MD | Northwestern University | Principal Investigator |
| Margaret Redfield, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2024 | Jun 24, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Wake Forest University Health Sciences | OTHER |
| University of Pennsylvania | OTHER |
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Cardiac tissue
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Mass General Brigham | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Wake Forest University | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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