Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-90
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
age < 55 years
BMI > 50 kg/m2
Atrial fibrillation with poorly controlled heart rate
phosphodiesterase type 5 (PDE5) inhibitor use
Trial design
Design model
Crossover
Treatments tested in this trial
HeO2 gas mixture
Other interventionLow-density helium-oxygen gas mixture (HeO2: 21% O2 and 79% He). Participant will be breathing this gas mixture.
Room air gas mixture
Other interventionNormal room air
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: HeO2 gas mixture, then Room air gas mixtureExperimental treatment 2 interventions
Group B: Room air gas mixture, then HeO2 gas mixtureExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
O2 cost of breathing (Objective 1)
O2 cost of breathing measured during eucapnic voluntary hyperventilation, and calculated using oxygen uptake and ventilation variables.
Time frame
Day 22
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.
Time frame
Day 3 or 43
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).
Time frame
Day 3 or 4Sponsors and contacts
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Source ClinicalTrials.gov