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Exercise Training for Heart Failure

N/A

Recruiting

Led By Daniel H Katz, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 18-89 years of age

Patients must carry a diagnosis of heart failure with ejection fraction < 40%

Must not have

Taking Any drugs used to treat diabetes mellitus or to lower blood glucose

Taking Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline vs week 12 proteomic profile

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate how exercise affects molecules in people with heart failure, to see if it can be mimicked with medicine. The goal is to develop an "exercise-in-a-pill" medicine to help people with heart failure.

Who is the study for?

This trial is for adults aged 18-89 with heart failure where the heart's pumping power is reduced (ejection fraction <40%). Participants must be willing to undergo cardiac rehabilitation and not be pregnant, planning pregnancy, or have given birth in the last year. They should not be on certain medications that could affect the study results or have had recent psychiatric hospitalizations.

What is being tested?

The study aims to understand how a 12-week cardiac rehabilitation exercise program affects protein levels in blood samples of heart failure patients. By comparing these changes to those whose rehab is delayed, researchers hope to identify potential targets for 'exercise-in-a-pill' treatments.

What are the potential side effects?

Cardiac rehabilitation generally has minimal side effects but may include muscle soreness, fatigue, and shortness of breath during exercise. The risk of more serious events like heart-related complications exists but is low.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 89 years old.

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My heart's pumping ability is less than 40%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication for diabetes or to lower my blood sugar.

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I am not taking any drugs to specifically increase muscle size.

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My kidneys are not working well (GFR <60).

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I haven't had treatment for autoimmune disorders in the last 6 months.

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I drink more than 7 (women)/14 (men) drinks weekly or have a history of binge drinking.

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I am taking growth hormone or similar treatments.

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I am currently taking monoclonal antibodies.

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I am currently taking medication to help me lose weight.

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I am currently taking narcotics or drugs that act like them.

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I understand and can follow the study's requirements.

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I have diabetes, as indicated by my medication or blood sugar levels.

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I am currently taking steroids or hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline vs week 12 proteomic profile

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline vs week 12 proteomic profile

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs week 12 proteomic profile for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Proteomic Profile: Acute

Change in Proteomic Profile: Chronic

Secondary study objectives

Proteomic predictors of Cardiopulmonary fitness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active arm: Acute exercise + 12 weeks Cardiac RehabilitationExperimental Treatment2 Interventions

This arm includes two-thirds of enrollees and focuses on both acute and chronic effects of exercise. Qualifying participants with heart failure randomized to this arm will undergo a 40 minute bout of moderate intensity exercise on a date prior to beginning in cardiac rehabilitation. Blood samples will be collected before and after the acute bout at 10, 30, and 210 minutes after exercise. Participants will 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 a second bout of acute exercise and blood sampling identical to the first. Finally, 12 weeks after completion of cardiac rehab, patients will return for another single blood sample.

Group II: Control arm: No exerciseActive Control1 Intervention

This arm includes one-third of enrollees and serves as control. Qualifying participants with heart failure randomized to this arm will begine with a 40 minute period of rest on a date prior to beginning in cardiac rehabilitation. Blood samples will be collected before and after the the 40 minute period at 10, 30, and 210 minutes after exercise. Participants will then defer cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks of this control intervention period. The participants will return after the 12 weeks of control intervention for an actual bout of acute exercise and blood sampling identical to those completed by the active arm. They will then enter cardiac rehabilitation as per standard of care. Finally, 12 weeks after completion of cardiac rehab, patients will return for another single blood sample.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acute exercise

2014

N/A

~150

Cardiac rehabilitation

2006

Completed Phase 3

~910