RECRUITING

Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05723679

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * signs and symptoms of heart failure
  2. * an ejection fraction \> 0.50;
  3. * objective evidence of diastolic dysfunction. elevated biomarkers (NT-proBNP \>300 ng/dl) or HF hospitalization
  4. * healthy volunteers
  1. * age \< 55 years
  2. * BMI \> 50 kg/m2
  3. * Atrial fibrillation with poorly controlled heart rate
  4. * phosphodiesterase type 5 (PDE5) inhibitor use
  5. * severe valvular disease
  6. * severe Chronic obstructive pulmonary disease (COPD)
  7. * Chronic kidney disease (CKD) 4 or higher
  8. * any restriction of ambulation and mobility.

Contacts and Locations

Study Contact

Raksa B Moran, RN
CONTACT
214-345-6574
raksamoran@texashealth.org
Jessica N Alcala, RN
CONTACT
214-345-6574
jessicaalcala@texashealth.org

Principal Investigator

Tony G Babb, Ph.D.
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Bryce N Balmain, Ph.D.
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Tony G Babb, Ph.D., PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center
  • Bryce N Balmain, Ph.D., PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • exertional dyspnea
  • exercise intolerance
  • HFpEF
  • breathing limitations
  • cardiopulmonary physiology

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction
  • Obesity