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 range

55 Years – 90 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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