Improving breathing and exercise capacity in heart failure patients with obesity
Targeting Breathing Limitations to Improve Functional Outcomes in Heart Failure With Preserved Ejection Fraction (HFpEF)
NA · University of Texas Southwestern Medical Center · NCT05723679
This study is testing if breathing a special helium-oxygen gas mixture can help people with heart failure and obesity breathe better and exercise more easily.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05723679 on ClinicalTrials.gov |
What this trial studies
This study investigates how pulmonary limitations affect exertional dyspnea and exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF) and obesity. It includes clinical screening tests such as cardiopulmonary exercise testing and pulmonary function testing to assess the interaction between HFpEF and obesity. The study will also conduct a randomized, placebo-controlled trial to evaluate the effects of breathing a helium-oxygen gas mixture on reducing obesity-related breathing constraints. The goal is to determine if this intervention can improve functional outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults with signs and symptoms of heart failure, an ejection fraction greater than 0.50, and evidence of diastolic dysfunction.
Not a fit: Patients under 55 years of age, those with a BMI over 50 kg/m2, or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved breathing and exercise capacity for patients suffering from HFpEF and obesity.
How similar studies have performed: While there have been studies on HFpEF and obesity, the specific approach of using a helium-oxygen gas mixture is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * signs and symptoms of heart failure * an ejection fraction \> 0.50; * objective evidence of diastolic dysfunction. elevated biomarkers (NT-proBNP \>300 ng/dl) or HF hospitalization * healthy volunteers Exclusion Criteria: * age \< 55 years * BMI \> 50 kg/m2 * Atrial fibrillation with poorly controlled heart rate * phosphodiesterase type 5 (PDE5) inhibitor use * severe valvular disease * severe Chronic obstructive pulmonary disease (COPD) * Chronic kidney disease (CKD) 4 or higher * any restriction of ambulation and mobility.
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Tony G Babb, Ph.D. — University of Texas Southwestern Medical Center
- Study coordinator: Raksa B Moran, RN
- Email: raksamoran@texashealth.org
- Phone: 214-345-6574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Preserved Ejection Fraction, Obesity, exertional dyspnea, exercise intolerance, HFpEF, breathing limitations, cardiopulmonary physiology