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Breathing Support for Heart Failure

N/A
Recruiting
Led By Bryce N Balmain, Ph.D.
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
Elevated biomarkers (NT-proBNP >300 ng/dl) or HF hospitalization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3 or 4
Awards & highlights

Study Summary

This trial will study if obesity makes it harder to breathe & exercise for those with heart failure & pulmonary issues.

Who is the study for?
This trial is for adults over 55 with heart failure, specifically HFpEF, and obesity but not extremely overweight (BMI <50 kg/m2). Participants should have symptoms of heart failure, preserved ejection fraction (>0.50), diastolic dysfunction evidence, elevated NT-proBNP levels or a history of hospitalization due to heart failure. Healthy volunteers can also join. Exclusions include severe lung or valve disease, advanced kidney disease (CKD 4+), uncontrolled atrial fibrillation, PDE5 inhibitor use, and mobility issues.Check my eligibility
What is being tested?
The study aims to see if breathing limitations affect shortness of breath during exercise and peak exercise ability in patients with HFpEF and obesity by using two different gas mixtures: regular room air versus a helium-oxygen mixture (HeO2).See study design
What are the potential side effects?
Since the interventions involve inhaling different gas mixtures rather than drugs, side effects may be minimal but could potentially include discomfort from wearing a mask or feelings of lightheadedness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am experiencing symptoms of heart failure.
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I have high heart failure markers or was hospitalized for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3 or 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3 or 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in DOE during HeO2 breathing (Objective 2)
Change in peak exercise capacity during HeO2 breathing (Objective 2)
O2 cost of breathing (Objective 1)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Room air gas mixture, then HeO2 gas mixtureExperimental Treatment2 Interventions
Participant will be randomized to each intervention on separate days (Study visit 3 and 4) in this cross-over trial. Participants that receive Room air first will then receive the HeO2 mixture. At least 24 hours will separate each visit.
Group II: HeO2 gas mixture, then Room air gas mixtureExperimental Treatment2 Interventions
Participant will be randomized to each intervention on separate days (Study visit 3 and 4) in this cross-over trial. Participants that receive HeO2 first will then receive the room air gas mixture. At least 24 hours will separate each visit.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,657 Total Patients Enrolled
23 Trials studying Obesity
5,381 Patients Enrolled for Obesity
Bryce N Balmain, Ph.D.Principal InvestigatorUT Southwestern Medical Center
Tony G Babb, Ph.D.Principal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
168 Total Patients Enrolled
2 Trials studying Obesity
168 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research available to adults over 25 years of age?

"This trial is recruiting patients aged 55 years or older, with the upper age limit being 90 years."

Answered by AI

Is there currently availability for individuals to partake in this clinical investigation?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical research project, which was initially announced on July 1st 2023, is currently searching for participants. 78 individuals need to be signed up from a single hospital site."

Answered by AI

What is the enrollment capacity of this trial?

"Affirmative. Clinicaltrials.gov states that this medical trial, which went public on July 1st 2023, is actively recruiting patients for its research study. 78 participants are needed from a single location to take part in the experiment."

Answered by AI

Is it likely that I could partake in this research project?

"This research is recruiting 78 individuals aged between 55 and 90 who are dealing with obesity. In order to be eligible, patients must present symptoms of heart failure, an ejection fraction that surpasses 0.50, elevated NT-proBNP (above 300 ng/dl) or a history of hospitalization related to HF; meanwhile healthy volunteers need also meet the criteria for diastolic dysfunction."

Answered by AI

Who else is applying?

What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF
Bryce Balmain 2023. "Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05723679.
~52 spots leftby Dec 2025
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