Exercise Training for Diastolic Heart Failure
(TEXPEF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether remote exercise training can enhance exercise capacity and muscle health in individuals with heart failure with preserved ejection fraction (HFpEF) or those at risk for it. Participants will engage in various exercise and lifestyle programs, including moderate-intensity continuous training (MCT) and resistance training, to determine the most effective approach. The goal is to discover better methods to reduce breathlessness and fatigue in people with HFpEF. This trial suits individuals diagnosed with HFpEF or at risk due to factors like diabetes, high blood pressure, or obesity. As a Phase 2/3 trial, the research measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in HFpEF care.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that there should be no active changes in heart failure therapies two weeks before the baseline visit, which might imply that you should maintain your current medication regimen.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that moderate-intensity continuous training (MCT) is generally safe for people with heart failure with preserved ejection fraction (HFpEF). Studies have found that MCT can improve heart function without major safety concerns, with very few reports of serious side effects, making it a well-tolerated option for many participants.
For resistance training, research suggests it is also safe for people with HFpEF. One study found that combining resistance exercises with endurance exercises improved participants' exercise ability and quality of life. Participants did not report significant adverse events, indicating it is well-tolerated.
Both exercise methods, MCT and resistance training, have shown promising safety records in previous studies. They are generally well-tolerated, with minimal serious side effects reported, making them promising options for those considering joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for diastolic heart failure because they integrate physical exercise with supportive coaching and, in some cases, weight management. Unlike traditional treatments that often rely heavily on medications like diuretics or blood pressure drugs, these approaches focus on moderate-intensity continuous training (MCT) and resistance training, which are delivered through personalized exercise videos. This method also includes virtual coaching to enhance adherence and motivation. The addition of pharmacological weight loss in some arms could further benefit patients by addressing obesity, a common contributor to heart failure. This holistic approach could potentially improve heart function and overall quality of life for patients.
What evidence suggests that this trial's treatments could be effective for heart failure with preserved ejection fraction?
Research has shown that exercise can significantly enhance exercise capacity and quality of life for individuals with heart failure with preserved ejection fraction (HFpEF). Studies have found that regular moderate-intensity exercise improves physical well-being and exercise capacity, even if it doesn't significantly alter heart function. In this trial, participants may be assigned to a treatment arm involving moderate-intensity continuous training (MCT) alone or combined with resistance training. Strength training also enhances exercise ability and quality of life; one study demonstrated a substantial improvement in heart and lung fitness. Combining these exercises might offer additional benefits. These findings suggest that exercise is a promising approach to managing HFpEF symptoms.13678
Are You a Good Fit for This Trial?
Adults with heart failure with preserved ejection fraction (HFpEF) or at risk for it, who experience exercise intolerance, can join this study. It's not clear what specific conditions exclude someone from participating.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I: Home-based Exercise Training
Participants undergo three months of home-based moderate-intensity continuous training (MCT) using tailored exercise videos and have weekly virtual meetings with a coach.
Detraining
Participants have a 3-month period of no intervention to assess the effects of detraining.
Phase II: Extended Training Strategies
Participants are randomized to one of four extended training strategies for 3 months: MCT alone, MCT plus resistance training, MCT plus weight loss, or MCT plus resistance training and weight loss.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Moderate-intensity continuous training (MCT)
- Resistance training
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor