Heart Failure With Normal Ejection FractionNCT03775577
Exercise Intolerance in Heart Failure
An observational study of Heart Failure With Normal Ejection Fraction, run by Johns Hopkins University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with and without heart failure will be enrolled.
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tricia Steinberg, MSN, 443-287-3469, asteinb3@jhmi.edu
About this study
Official title: Exercise Intolerance in Heart Failure: the Role of Altered Cardiac and Skeletal Muscle Energetics
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.
- Keywords
- Heart Failure with Preserved Ejection Fraction, HFpEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle mitochondrial function
Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)
Measured: Baseline
Skeletal muscle energetic decline during exercise
Creatine phosphate rate of decline (umol/g/min) during plantar flexion exercise measured by 31P MRS
Measured: Baseline
Cardiac muscle energetics
Cardiac muscle phosphocreatine (PCr)/ adenosine triphosphate (ATP) and creatine kinase(CK) flux (umol/g/s) measured by 31P MRS
Measured: Baseline
Secondary outcomes (5)
Six minute walk test
Six minute walk distance (m)
Measured: Six months
Cardiopulmonary exercise testing (CPET)
Peak whole-body oxygen consumption rate during exercise
Measured: Six months
Clinical heart failure outcome as assessed by number of hospitalizations
Measured: Two years
Clinical heart failure outcome as assessed by time to cardiovascular death
Measured: Two years
Clinical heart failure outcome as assessed by overall mortality
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start1 Apr 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Normal Ejection FractionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Robert G Weiss, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775577
- Sponsor's protocol ID
- IRB00129787
- Other IDs
- R01HL061912
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2018
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intolerance in Heart Failure: the Role of Altered Cardiac and Skeletal Muscle Energetics
- ClinicalTrials.gov ID
- NCT03775577
- Acronym / sponsor ID
- IRB00129787
- Keywords
- Heart Failure with Preserved Ejection Fraction, HFpEF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with and without heart failure will be enrolled.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skeletal muscle mitochondrial function
Time frame: Baseline
Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)
Skeletal muscle energetic decline during exercise
Time frame: Baseline
Creatine phosphate rate of decline (umol/g/min) during plantar flexion exercise measured by 31P MRS
Cardiac muscle energetics
Time frame: Baseline
Cardiac muscle phosphocreatine (PCr)/ adenosine triphosphate (ATP) and creatine kinase(CK) flux (umol/g/s) measured by 31P MRS
5 secondary outcomes
Six minute walk test
Time frame: Six months
Cardiopulmonary exercise testing (CPET)
Time frame: Six months
Clinical heart failure outcome as assessed by number of hospitalizations
Time frame: Two years
Clinical heart failure outcome as assessed by time to cardiovascular death
Time frame: Two years
Clinical heart failure outcome as assessed by overall mortality
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert G Weiss, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Normal Ejection Fraction, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Kauffman (443-287-3475, mkauffm7@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle mitochondrial function (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.