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Exercise Training for Heart Failure
N/A
Recruiting
Led By Bryan J Taylor, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
NYHA functional class I-IIIb
Be older than 18 years old
Must not have
Musculoskeletal or other conditions that would limit exercise participation
Comorbidities such as obesity (BMI >36), uncontrolled systemic hypertension, type 2 diabetes, and COPD (FEV1 <50%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.
Who is the study for?
This trial is for heart failure patients with reduced heart function (LVEF < 40%) who've been stable for over 3 months and can exercise on a bike or treadmill. It's not for those in the most severe stage of heart failure, pregnant women, individuals with certain other health issues like severe obesity or uncontrolled diabetes, or conditions that limit exercise.
What is being tested?
The study is testing if regular exercise can improve how well the heart works, overall health, and life quality in people with pulmonary hypertension due to heart failure. Participants will follow an exercise program using bikes or treadmills.
What are the potential side effects?
Exercise training may lead to general discomforts such as muscle soreness, fatigue, shortness of breath during activity, and increased risk of falls or injuries related to physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition allows me to perform daily activities with slight to moderate limitations.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition that limits my ability to exercise.
Select...
I have conditions like severe obesity, uncontrolled high blood pressure, type 2 diabetes, or severe COPD.
Select...
I have been diagnosed with heart failure that affects how my heart fills.
Select...
I have severe heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximal oxygen uptake (VO2max) measured in mL/kg/min
Secondary study objectives
Left ventricular contractile function measured as % fractional area change (LV FAC).
Mean pulmonary arterial pressure (mPAP) measured in mmHg
Pulmonary vascular resistance (PVR) measured in dynes
+2 moreAwards & 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: Exercise TrainingExperimental Treatment1 Intervention
Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida.
Group II: Control GroupsActive Control1 Intervention
Two sets of exercise testing while continuing with standard medical care in between.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,135 Total Patients Enrolled
Florida Heart Research InstituteOTHER
2 Previous Clinical Trials
180 Total Patients Enrolled
Bryan J Taylor, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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