RECRUITING

Exercise Intolerance in Heart Failure

Conditions

Heart Failure With Normal Ejection Fraction Heart Failure with Preserved Ejection Fraction HFpEF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Exercise Intolerance in Heart Failure: the Role of Altered Cardiac and Skeletal Muscle Energetics

Quick Facts

Study Start:2017-04-01

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03775577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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

Inclusion Criteria

Exclusion 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).

* 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

Contacts and Locations

Study Contact

Matthew Kauffman

CONTACT

443-287-3475

mkauffm7@jhmi.edu

Tricia Steinberg, RN, MSN

CONTACT

443-287-3469

asteinb3@jhmi.edu

Principal Investigator

Robert G Weiss, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Robert G Weiss, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-04-01

Study Completion Date2025-03

Study Record Updates

Study Start Date2017-04-01

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

Heart Failure with Preserved Ejection Fraction
HFpEF

Additional Relevant MeSH Terms

Heart Failure With Normal Ejection Fraction