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Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF

Targeting Breathing Limitations to Improve Functional Outcomes in Heart Failure With Preserved Ejection Fraction (HFpEF)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 90 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Clinical screening tests including cardiopulmonary exercise testing (CPET), pulmonary function testing, and dual-energy x-ray absorptiometry (DEXA) scans will be performed on all subjects."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether breathing that uses more oxygen makes people more short of breath during activity and limits exercise. It focuses on people with obesity and HFpEF, a type of heart failure where the heart pumps well but has trouble relaxing and filling. Healthy volunteers may also join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Signs and symptoms of heart failure.
  • The heart pumps out more than 50% of its blood with each beat.
  • Tests show the heart has trouble relaxing and filling, a heart strain blood marker (NT-proBNP) is above 300 ng/dl, or a past hospital stay for heart failure.
  • Healthy volunteers are also listed as eligible.

Who can't join

  • Younger than 55.
  • Body mass index (BMI), a measure of weight compared with height, above 50.
  • Atrial fibrillation, an uneven heartbeat, with a poorly controlled heart rate.
  • Use of a medicine called a PDE5 inhibitor.
  • Severe heart valve disease.
  • Severe COPD, a long-term lung disease that makes breathing hard.
  • Stage 4 or higher chronic kidney disease, meaning severe loss of kidney function.
  • Any limits on walking or moving around.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

TX