Identifying Markers of Exercise Training in Heart Failure

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Acute exercise — BEHAVIORAL
  40 minute moderate intensity exercise bout on a treadmill. This is similar to a single session of cardiac rehabilitation.
• Cardiac rehabilitation — BEHAVIORAL
  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.

Study Details

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 Dates

Start date

Mar 20, 2024

Status verified

Feb 2026

Primary completion

May 26, 2028

Completion

Apr 1, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

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.

Primary Outcome Measure

Change in Proteomic Profile: Chronic [ Time Frame: Baseline vs week 12 proteomic profile ]

Locations (1)

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