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Exercise Intolerance in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775577
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University

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.

Condition or disease
Heart Failure With Normal Ejection Fraction

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exercise Intolerance in Heart Failure: the Role of Altered Cardiac and Skeletal Muscle Energetics
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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 Measures :
  1. Skeletal muscle mitochondrial function [ Time Frame: Baseline ]
    Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Six minute walk test [ Time Frame: Six months ]
    Six minute walk distance (m)

  2. Cardiopulmonary exercise testing (CPET) [ Time Frame: Six months ]
    Peak whole-body oxygen consumption rate during exercise

  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 ]

Biospecimen Retention:   Samples With DNA
Blood Specimens


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People with and without heart failure will be enrolled.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775577


Contacts
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Contact: Matthew Kauffman 443-287-3475 mkauffm7@jhmi.edu
Contact: Tricia Steinberg, RN, MSN 443-287-3469 asteinb3@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tricia Steinberg, MSN    443-287-3469    asteinb3@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Robert G Weiss, MD Johns Hopkins University
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Responsible Party: Robert G. Weiss, Study Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03775577    
Other Study ID Numbers: IRB00129787
R01HL061912 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert G. Weiss, Johns Hopkins University:
Heart Failure with Preserved Ejection Fraction
HFpEF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases