Recruiting

Observational StudyIdentifying Markers of Exercise Training in Heart Failure

Sponsor:

Stanford University

Code:

NCT05696652

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acute exercise

Cardiac rehabilitation

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT05696652

Start date

Mar 20, 2024

Status verified date

Feb, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

May 26, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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)
Diabetes (self-report and screening), which includes: i) treatment with any insulin or ii) A1c >=8.0 (screening). (verbal/chart)
Chronic renal insufficiency (screening): estimated glomerular filtration rate <30 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation. (verbal/chart)
Individuals receiving any active treatment for autoimmune disorders (including monoclonal antibodies) within the last 6 months. (verbal/chart)
Alcohol consumption: i) more than 7 drinks per week for women and more than 14 drinks per week for men; ii) history of binge drinking. (verbal/chart)
Any individual engaging in night shift work in the last 6 months.
Hospitalization for any psychiatric condition within one year (verbal/chart)
Any musculoskeletal or ligamentous injury, amputation or congenital neurological defect that, in the opinion of the team clinician, would negatively impact or mitigate participation in and completion of the protocol. (verbal/chart)
Mental incapacity and/or cognitive impairment on the part of the participant that would inhibit adequate understanding of or cooperation with the study protocol
Other (clinician judgment)

Genetic metabolic disorders that could affect metabolomic results (e.g., phenylketonuria)
Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, metabolic, or other conditions that, in the opinion of the local clinician, would preclude participation and successful completion of the protocol
Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol
Medication exclusions (chart review)

Androgenic anabolic steroids, antiestrogens, antiandrogens
Growth hormone, insulin like growth factor, growth hormone releasing hormone
Insulin of any type used regularly
Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise induced muscle hypertrophy
Psychiatric

Chronic use of medium- or long-acting sedatives and hypnotics, including all benzodiazepines; short-acting non-benzodiazepine sedative-hypnotics are allowed
Two or more drugs for depression
Mood stabilizers
Antiepileptic drugs
Stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs
Anti-psychotic drugs
Narcotics and narcotic receptor agonists
Chronic systemic antimicrobials (antibiotic, antiviral, antifungal, antiparasite, etc) for any reason
High-potency topical steroids if ≥10% of surface area using rule of 9s
Continuous/chronic use of antibiotics or other anti-infectives for treatment or prevention
Monoclonal antibodies
Anti-rejection medications/immune suppressants
Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active arm: Acute exercise

This arm includes two-thirds of enrollees and focuses on acute effects of exercise. Qualifying participants with heart failure randomized to this arm will undergo a 40 minute bout of moderate intensity exercise. Blood samples will be collected before and after the acute bout at 10, 30, and 210 minutes after exercise.

no intervention: Control arm: No exercise (Acute Comparison)

This arm includes one-third of enrollees and serves as control. Qualifying participants with heart failure randomized to this arm will begin with a 40 minute period of rest. Blood samples will be collected before and after the the 40 minute period at 10, 30, and 210 minutes after the start.

experimental: Active Arm: 12 weeks Cardiac Rehabilitation

This arm includes two-thirds of enrollees for the training intervention and focuses on chronic effects of exercise. Participants have a baseline blood sample and then go to cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks. The participants will return after the 12 weeks of cardiac rehabilitation for another single blood sample.

no intervention: Control: No Exercise (Training)

Participants receive baseline fasting blood sample and then defer cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks of this control intervention period. 12 weeks after enrollment, patients will return for another single blood sample.

Interventions

Acute exercise

40 minute moderate intensity exercise bout on a treadmill. This is similar to a single session of cardiac rehabilitation.

Cardiac rehabilitation

12 week program of standard clinical cardiac rehabilitation for patients with symptomatic heart failure. Patients undergo 3-times weekly sessions of monitored exercise for 12 weeks. This is the same cardiac rehabilitation patients would get as part of clinical care.

Primary outcome measure

Change in Proteomic Profile: Chronic [ Time Frame: Baseline vs week 12 proteomic profile ]
Change in Proteomic Profile: Acute [ Time Frame: Acute bout vs control; Baseline vs week 12 proteomic profile of acute exercise ]

Central Contacts and Locations

Locations

Stanford Health Care

Recruiting

Stanford, California, United States, 94305

Contacts

Mia Levanto

650-498-5673 motrx-hf-shc@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-13.