Clinical trial Recruiting at 1 site Interventional Ages 55 to 90

Improving breathing and exercise capacity in heart failure patients with obesity

Official title: Targeting Breathing Limitations to Improve Functional Outcomes in Heart Failure With Preserved Ejection Fraction (HFpEF)

Run by University of Texas Southwestern Medical Center · NCT05723679 · Data updated 2026-11-12

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

Study typeInterventional
Ages55 Years to 90 Years
SexAll
Enrollment78 (estimated)
SponsorUniversity of Texas Southwestern Medical Center
Academic / other
Locations1 site (Dallas, Texas)
StatusRecruiting
StartedJuly 1, 2023
Main results expectedJune 30, 2028
Study endsJune 30, 2029
Registry record updatedMay 7, 2026
Trial IDNCT05723679 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • UT Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.