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Exercise Training for Heart Failure
N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Signs and symptoms of heart failure
signs and symptoms of heart failure
Must not have
CKD 4 or higher
Age < 60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether different types of exercise training programs can improve exercise tolerance for people with heart failure and preserved ejection fraction.
Who is the study for?
This trial is for people over 60 with heart failure who still have a decent amount of blood pumped from their heart each beat (ejection fraction > 0.50) and signs of poor relaxation of the heart muscle. They shouldn't be extremely overweight, taking certain drugs for erectile dysfunction, have severe valve disease or lung problems, very poor kidney function, or an inability to undergo MRI scans.
What is being tested?
The study aims to understand why patients with HFpEF get tired easily during exercise and feel shortness of breath. It will test if specific types of exercise programs can help improve their ability to exercise without getting as tired or breathless.
What are the potential side effects?
Since this trial involves exercise training programs, potential side effects may include muscle soreness, fatigue, joint pain or discomfort during physical activity. The risks are generally low but depend on individual health status.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am experiencing signs of heart failure.
Select...
I show signs or symptoms of heart failure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is severely reduced.
Select...
I am younger than 60 years old.
Select...
I have a serious heart valve problem.
Select...
I am currently taking medication for erectile dysfunction.
Select...
I have severe chronic obstructive pulmonary disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aerobic fitness
Secondary study objectives
Cardiac fibrosis
Cardiopulmonary hemodynamics
Leg blood flow
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Peripheral HFpEF whole body exerciseExperimental Treatment1 Intervention
HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to whole body cycle training.
Group II: Peripheral HFpEF isolated single leg exerciseExperimental Treatment1 Intervention
HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to isolated single leg training.
Group III: Central HFpEF whole body exerciseExperimental Treatment1 Intervention
HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to whole body cycle training.
Group IV: Central HFpEF isolated single leg exerciseExperimental Treatment1 Intervention
HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to isolated single leg training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise training
2019
Completed Phase 1
~1110
Find a Location
Who is running the clinical trial?
The University of Texas at ArlingtonOTHER
44 Previous Clinical Trials
4,765 Total Patients Enrolled
1 Trials studying Heart Failure
12 Patients Enrolled for Heart Failure
University of Texas-ArlingtonUNKNOWN
4 Previous Clinical Trials
650 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,089 Total Patients Enrolled
26 Trials studying Heart Failure
13,652 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping function is too high.There is clear evidence of problems with how the heart relaxes between beats.Your body mass index (BMI) is higher than 50.There is clear proof of problems with how your heart relaxes between beats.My kidney function is severely reduced.Your heart's ejection fraction is greater than 50%.I am younger than 60 years old.I am experiencing signs of heart failure.I have a serious heart valve problem.I am currently taking medication for erectile dysfunction.You cannot have an MRI for medical reasons.I have severe chronic obstructive pulmonary disease.I show signs or symptoms of heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Peripheral HFpEF isolated single leg exercise
- Group 2: Central HFpEF isolated single leg exercise
- Group 3: Central HFpEF whole body exercise
- Group 4: Peripheral HFpEF whole body exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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