Identifying Markers of Exercise Training in Heart Failure

Recruiting now · Not applicable

Conditions studied: Heart Failure

In brief

The heart failure syndrome that occurs when the heart is too sick to properly do its job. One of the main symptoms is difficulty with exercise. One way to improve symptoms is to start patients in a 12 week exercise program called cardiac rehabilitation. Cardiac rehabilitation been shown to improve symptoms for heart failure patients. However, the investigators do not know exactly what exercise does to the molecules that make up the human body. If the investigators could answer this question, the investigators might find a whole new way to treat the symptoms of heart failure. Therefore the investigators want to know what molecules might be responsible for the benefits of exercise. The plan for this study is to measure the levels of thousands of proteins in blood samples which come from people with heart failure and see how those levels change after 12 weeks of cardiac rehabilitation, compared to the protein levels in patients whose cardiac rehabilitation is delayed until after the study period. If the investigators know the proteins that change with exercise, the investigators can then look to see if targeting these proteins with medicines can mimic the benefits of exercise. The long term goal of our work is to identify "exercise-in-a-pill" medicines that will help people with heart failure.

Key facts

Study ID: NCT05696652
Run by: Stanford University
People needed: 90
Starts: 2024-03-20
Expected to finish: 2029-04-01
Last updated by the study team: 2026-02-13

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18-89
Patients must carry a diagnosis of heart failure with ejection fraction < 40%
Be willing to participate in cardiac rehabilitation, and not already done so in the last year
Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Must be able to exercise on a treadmill

You may not qualify if…

Inability to complete CPET or participate in CR (verbal/chart)
Syncope during CPET within the last 6 mos, sustained VT on CPET, hemodynamically significant arrhythmia during CPET (verbal/chart)
BMI >= 38 (verbal/chart)
History of a bleeding disorder or clotting abnormality (verbal/chart)
Clinical diagnosis of severe Chronic Obstructive Pulmonary Disease (COPD) (verbal/chart)
History of malignancy not considered in remission (verbal/chart)
Cirrhosis (verbal/chart)
Thyroid disease (verbal/chart)
Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory within the last 1 year
Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for ≥3 months prior to retesting
Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment
Cancer (verbal/chart)
History of cancer treatment (other than non-melanoma skin cancer) and not "cancer-free" for at least 2 years
Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months
Chronic active or latent infection (verbal/chart)
Active or latent infections requiring chronic antibiotic or anti-viral treatment
Chronic active infection whether on chronic antimicrobials or not
Human Immunodeficiency Virus
Active hepatitis B or C undergoing antiviral therapy
Individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded
Tobacco (verbal/chart)
Current smokers: any tobacco or e-cigarette/e-nicotine products
Former smokers: Stopped smoking <6 months at time of screening
Not be pregnant or lactating in the last 12 months, or planning to become pregnant for the next 4 months. Not be post-partum during the last 12 months. (verbal/chart)
Metabolic bone disease (self-report): History of non-traumatic fracture from a standing height or less. Current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen. (verbal/chart)

Where it is running

Stanford Health Care — Stanford, California, United States (enrolling)

Full record on ClinicalTrials.gov

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