What this study is
The overall purpose of this study is to investigate whether pulmonary limitations that increase the oxygen (O2) cost of breathing impact dyspnea on exertion (DOE) and peak exercise capacity in patients with HFpEF and obesity. As per investigator's hypothesis, obesity is likely a significant contributor to DOE and exercise intolerance in patients with HFpEF.
What's being tested
- HeO2 gas mixture
Intervention · OTHER
Low-density helium-oxygen gas mixture (HeO2: 21% O2 and 79% He). Participant will be breathing this gas mixture.
- Room air gas mixture
Intervention · OTHER
Normal room air
Study details
- Official title
- Targeting Breathing Limitations to Improve Functional Outcomes in Heart Failure With Preserved Ejection Fraction (HFpEF)
- Sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Heart Failure With Preserved Ejection Fraction · Obesity
- Enrolling
- 78 people
- Starts
- 2023-07-01
- Est. completion
- 2029-06-30
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years – 90 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUT Southwestern Medical Center
Dallas, Texas, United States
- Raksa B Moran, RN · Contact2143456574raksamoran@texashealth.org
- Jessica N Alcala, RN · Contact2143456574jessicaalcala@texashealth.org
Recruiting
Study team
Sponsor
University of Texas Southwestern Medical Center
Study ID STU-2022-1174
Principal investigator
Tony G Babb, Ph.D.
University of Texas Southwestern Medical Center
Principal investigator
Bryce N Balmain, Ph.D.
University of Texas Southwestern Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.