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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
Be willing to participate in cardiac rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs week 12 proteomic profile
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am willing to join a heart health program.
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My heart's pumping ability is less than 40%.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Proteomic Profile: Acute
Change in Proteomic Profile: Chronic
Secondary outcome measures
Proteomic predictors of Cardiopulmonary fitness

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
~130
Cardiac rehabilitation
2006
Completed Phase 3
~860

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER
320 Previous Clinical Trials
4,932,398 Total Patients Enrolled
30 Trials studying Heart Failure
137,539 Patients Enrolled for Heart Failure
Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,269 Total Patients Enrolled
16 Trials studying Heart Failure
56,096 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,667 Total Patients Enrolled
204 Trials studying Heart Failure
677,186 Patients Enrolled for Heart Failure

Media Library

Cardiac rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05696652 — N/A
Heart Failure Research Study Groups: Control arm: No exercise, Active arm: Acute exercise + 12 weeks Cardiac Rehabilitation
Heart Failure Clinical Trial 2023: Cardiac rehabilitation Highlights & Side Effects. Trial Name: NCT05696652 — N/A
Cardiac rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696652 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals of a certain age have access to participate in this research?

"As stated by the eligibility requirements, participants in this medical trial must be aged between 18 and 89 years old."

Answered by AI

Are there any open enrollment opportunities for this clinical trial at present?

"According to the clinicaltrials.gov resource, this medical investigation is not currently enlisting patients. Despite initially being posted on October 1st 2023 and last updated on January 13th 2023, there are still 697 other trials actively recruiting individuals at present."

Answered by AI

Would I qualify to participate in this research endeavor?

"This investigation is recruiting 90 volunteers aged 18-89 with a diagnosis of heart failure and ejection fraction below 40%. To be eligible, they must not have been pregnant/lactating in the past year nor plan to become pregnant within the next four months. A pregnancy test will also be conducted for women of childbearing age on DXA scan day. Additionally, participants must provide informed consent and take part in cardiac rehabilitation."

Answered by AI
~60 spots leftby Mar 2027