CClinicalTrials.gg
RecruitingNCT03775577Updated Mar 9, 2026

Exercise Intolerance in Heart Failure

An observational study in Heart Failure With Normal Ejection Fraction, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Johns Hopkins University · Observational

From the registry’s dates

  • Started Apr 2017; still recruiting 9 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed description

This research is being done to better understand why patients with heart failure have difficulty exercising and performing some activities of daily living. Heart muscle and skeletal muscle (in the legs and arms) depend on normal metabolism (the conversion of foods to chemical fuel) to function properly. Investigators will measure metabolites in the heart and leg muscles, including the levels of high energy phosphates and lipids (fats) using magnetic resonance (MR) techniques. High-energy phosphates serve as a source of energy, which is used by the heart and skeletal muscle for contraction. Magnetic resonance uses magnetic fields to measure the levels of these substances.

02

Conditions studied

  • Heart Failure With Normal Ejection Fraction

Keywords

  • Heart Failure with Preserved Ejection Fraction
  • HFpEF
03

In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

People with and without heart failure will be enrolled.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Skeletal muscle mitochondrial function

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

    Time frame: Baseline

  2. Skeletal muscle energetic decline during exercise

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

    Time frame: Baseline

  3. Cardiac muscle energetics

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

    Time frame: Baseline

Secondary outcomes

  1. Six minute walk test

    Six minute walk distance (m)

    Time frame: Six months

  2. Cardiopulmonary exercise testing (CPET)

    Peak whole-body oxygen consumption rate during exercise

    Time frame: Six months

  3. Clinical heart failure outcome as assessed by number of hospitalizations

    Time frame: Two years

  4. Clinical heart failure outcome as assessed by time to cardiovascular death

    Time frame: Two years

  5. Clinical heart failure outcome as assessed by overall mortality

    Time frame: Two years

07

Study locations

1 of 1 sites recruiting
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03775577
Lead sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Dec 14, 2018
Start date
Apr 1, 2017
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Mar 9, 2026

Study contacts

Matthew Kauffman
Contact
mkauffm7@jhmi.edu
443-287-3475
Tricia Steinberg, RN, MSN
Contact
asteinb3@jhmi.edu
443-287-3469
Robert G Weiss, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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