Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
NCT ID: NCT06517186
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2024-11-08
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HFpEF
Participants with HFpEF
No interventions assigned to this group
Non-HFpEF
Participants without HFpEF
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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
30 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Massachusetts General Hospital
OTHER
Brigham and Women's Hospital
OTHER
Mayo Clinic
OTHER
Wake Forest University Health Sciences
OTHER
University of Pennsylvania
OTHER
Northwestern University
OTHER
Responsible Party
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Sanjiv Shah
Stone Endowed Professor of Medicine, Director of Research, Bluhm Cardiovascular Institute, Principal Investigator, HeartShare Data Translation Center
Principal Investigators
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Sanjiv Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Margaret Redfield, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mass General Brigham
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Ben Nelson
Role: primary
Tiffany Sharkoski
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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24-000688
Identifier Type: -
Identifier Source: org_study_id
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