NCT05723679

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
38mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jul 2023Jun 2029

First Submitted

Initial submission to the registry

January 27, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

January 27, 2023

Last Update Submit

May 1, 2026

Conditions

Heart Failure With Preserved Ejection FractionObesity

Keywords

exertional dyspneaexercise intoleranceHFpEFbreathing limitationscardiopulmonary physiology

Outcome Measures

Primary Outcomes (3)

  • O2 cost of breathing (Objective 1)

    O2 cost of breathing measured during eucapnic voluntary hyperventilation, and calculated using oxygen uptake and ventilation variables.

    Day 2

  • Change in DOE during HeO2 breathing (Objective 2)

    Dyspnea on Exertion (DOE) will be assessed via ratings of perceived breathlessness (RPB) using a 0-10 Borg Scale, and will be compared with that measured during room air breathing.

    Day 3 or 4

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

    Peak exercise capacity will be assessed by measuring peak oxygen uptake (in L/min, measured via a breath-by-breath metabolic measurement system), peak power output recorded from a cycle ergometer (Watts), and/or total exercise duration (minutes).

    Day 3 or 4

Study Arms (2)

HeO2 gas mixture, then Room air gas mixture

EXPERIMENTAL

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.

Other: HeO2 gas mixtureOther: Room air gas mixture

Room air gas mixture, then HeO2 gas mixture

EXPERIMENTAL

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.

Other: HeO2 gas mixtureOther: Room air gas mixture

Interventions

HeO2 gas mixtureOTHER

Low-density helium-oxygen gas mixture (HeO2: 21% O2 and 79% He). Participant will be breathing this gas mixture.

HeO2 gas mixture, then Room air gas mixtureRoom air gas mixture, then HeO2 gas mixture
Room air gas mixtureOTHER

Normal room air

HeO2 gas mixture, then Room air gas mixtureRoom air gas mixture, then HeO2 gas mixture

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tony G Babb, Ph.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

  • Bryce N Balmain, Ph.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raksa B Moran, RN

CONTACT

214-345-6574raksamoran@texashealth.org

Jessica N Alcala, RN

CONTACT

214-345-6574jessicaalcala@texashealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The order of the room air and HeO2 tests will be randomized and the subjects will not be told what gas mixture they will be breathing.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Mechanistic Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 13, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)