Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05723679
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • HeO2 gas mixture — OTHER
    Low-density helium-oxygen gas mixture (HeO2: 21% O2 and 79% He). Participant will be breathing this gas mixture.
  • Room air gas mixture — OTHER
    Normal room air

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: HeO2 gas mixture, then Room air gas mixture
    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.
  • Experimental: Room air gas mixture, then HeO2 gas mixture
    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.

Primary Outcome Measure

O2 cost of breathing (Objective 1) [ Time Frame: Day 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Raksa B Moran, RN
[email protected]
2143456574
Jessica N Alcala, RN
[email protected]
2143456574

Find similar trials in Dallas, TX

By condition
Heart failureObesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
UT Southwestern Medical Center· Dallas, TX

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