RecruitingNot Applicable

Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF

United States78 participantsStarted 2023-07-01

Plain-language summary

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 participate

Age range55 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

O2 cost of breathing (Objective 1)

Timeframe: Day 2

Change in DOE during HeO2 breathing (Objective 2)

Timeframe: Day 3 or 4

Change in peak exercise capacity during HeO2 breathing (Objective 2)

Timeframe: Day 3 or 4

Trial details

NCT IDNCT05723679

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Raksa B Moran, RN

214-345-6574 raksamoran@texashealth.org

View on ClinicalTrials.gov More Heart Failure With Preserved Ejection Fraction trials