Clinical trial

Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF

Recruiting now · Not applicable · 1 countries · Registry ID NCT05723679

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to 90 Years

SexAll

Healthy volunteersAccepted

ConditionHeart Failure With Preserved Ejection Fraction, Obesity

Full registry criteria

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.

Treatments and study arms

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

Primary outcomes

O2 cost of breathing (Objective 1)Day 2

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

Change in DOE during HeO2 breathing (Objective 2)Day 3 or 4

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.

Change in peak exercise capacity during HeO2 breathing (Objective 2)Day 3 or 4

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).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UT Southwestern Medical Center🇺🇸 Dallas, Texas, United States

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Raksa B Moran, RNContact

Email · Call 2143456574

Jessica N Alcala, RNContact

Email · Call 2143456574