Health TrialsbyHealthPanel

Exercise Intolerance in Heart Failure

ConditionHeart Failure With Normal Ejection Fraction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial population

People with and without heart failure will be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

130 Participants
are grouped into 4 trial groups
Group A: HFpEF
Group B: HFrEF
Group C: Hypertensive Subjects
Group D: Healthy Subjects

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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