Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT03775577

Conditions

Heart Failure With Normal Ejection Fraction

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The investigators are studying whether metabolic abnormalities in cardiac and skeletal muscle in patients with heart failure with preserved ejection fraction (HFpEF) are associated with debilitating exercise intolerance.

Conditions

Heart Failure With Normal Ejection Fraction

Study ID

NCT03775577

Start date

Apr 1, 2017

Status verified date

Mar, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients of either gender who are greater than 21 years of age (no upper age limit),
  • Permission of patient's clinical attending physician,
  • Previous clinical diagnosis of HF with current New York Heart Association (NYHA) Class II-III symptoms for at least 1 month,
  • Left ventricular ejection fraction (EF) >50% by echocardiography, MRI, CT or x-ray or nuclear ventriculography within prior 12 months,
  • Stable medical therapy for at least 30 days (no addition or removal or major (>100%) dose change of Renin-Angiotensin-Aldosterone System (RAAS) antagonists, beta-blockers, or calcium channel blockers for hypertension).

Exclusion Criteria:

  • Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent,
  • Contraindications to MRI such as implanted metallic objects (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles,
  • Significant valvular abnormalities,
  • Pregnant women (women of childbearing potential will undergo blood or urine pregnancy testing),
  • History of clinical CAD or significant epicardial coronary disease (>50% stenosis) in major coronary artery by x-ray or CT angiography unless (a) the patient underwent prior successful revascularization with percutaneous coronary angioplasty within the prior three years and (b) there are no residual lesions of >50% on the most recent coronary angiographic study.
  • History of infiltrative cardiomyopathy or constrictive pericarditis,
  • Cor pulmonale,
  • Significant pulmonary disease,
  • Estimated glomerular filtration rate (eGFR) <20ml/min,
  • Any condition other than HF which could limit the ability to perform a 6MW or cardiopulmonary exercise test (CPET) test (e.g., critical peripheral vascular disease, significant orthopedic or neurological conditions),
  • Any diseases other than HF which are likely to significantly alter the patient's global perception of status or quality of life over a period of 6 months.
  • Significant peripheral vascular disease

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

HFpEF

Participants with Heart Failure with Preserved Ejection Fraction

HFrEF

Participants with Heart Failure with Reduced Ejection Fraction

Hypertensive Subjects

Participants with Hypertension

Healthy Subjects

Participants without heart failure and without commodities

Primary outcome measure

  • Skeletal muscle mitochondrial function [ Time Frame: Baseline ]
  • Skeletal muscle energetic decline during exercise [ Time Frame: Baseline ]
  • Cardiac muscle energetics [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Matthew Kauffman

443-287-3475mkauffm7@jhmi.edu

Tricia Steinberg, RN, MSN

443-287-3469asteinb3@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Tricia Steinberg, MSN

443-287-3469asteinb3@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • Heart Failure with Preserved Ejection Fraction
  • HFpEF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-09.