Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF
Recruiting · NCT05723679 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
HeO2 gas mixtureRoom air gas mixture
What this trial is about
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.
Who can take part
Age range
55 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- UT Southwestern Medical Center - Dallas, Texas, United States