Exercise Intolerance in Heart Failure

NCT03775577 | Recruiting

• 2 other identifiers: IRB00129787R01HL061912
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

Heart Failure with Preserved Ejection Fraction; HFpEF

Outcome Measures

Primary Outcomes (3)

• Skeletal muscle mitochondrial function

  Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)

  Baseline

• Skeletal muscle energetic decline during exercise

  Creatine phosphate rate of decline (umol/g/min) during plantar flexion exercise measured by 31P MRS

  Baseline

• Cardiac muscle energetics

  Cardiac muscle phosphocreatine (PCr)/ adenosine triphosphate (ATP) and creatine kinase(CK) flux (umol/g/s) measured by 31P MRS

  Baseline

Secondary Outcomes (5)

• Six minute walk test

  Six months

• Cardiopulmonary exercise testing (CPET)

  Six months

• Clinical heart failure outcome as assessed by number of hospitalizations

  Two years

• Clinical heart failure outcome as assessed by time to cardiovascular death

  Two years

• Clinical heart failure outcome as assessed by overall mortality

  Two years

Study Arms (4)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with and without heart failure will be enrolled.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Specimens

Study Officials

• Robert G Weiss, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Kauffman

CONTACT

443-287-3475; mkauffm7@jhmi.edu

Tricia Steinberg, RN, MSN

CONTACT

443-287-3469; asteinb3@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: December 14, 2018
• Study Start: April 1, 2017
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)