Status:
ACTIVE_NOT_RECRUITING
Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
The Pittsburgh Foundation
Conditions:
Aging
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
In a randomized controlled trial, to study the utility of inspiratory muscle training (IMT) to improve functional outcomes in adults aged ≥70 years with heart failure (HF) who have been referred to pa...
Detailed Description
Heart failure (both HF with reduced ejection fraction \[HFrEF\] and HF with preserved ejection fraction \[HFpEF\]) are on the rise in our aging population. Exercise intolerance is a leading detriment ...
Eligibility Criteria
Inclusion
- Patients with Advanced Heart Failure (HFrEF or HFpEF), with NYHA class II, III, or IV despite a minimum of
- 6 weeks of treatment
- Age \>70 years
- Male and Female
- Optimal therapy according to AHA/ACC and HFSA HF guidelines
Exclusion
- Patients living in an institutional setting (e.g., skilled nursing home) during the intended period of this study.
- Major cardiovascular event or procedure within the prior 6 weeks.
- HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction). If valve replacement has been performed, the participant may not be enrolled for 12 months after this procedure.
- Dementia
- Severe COPD (FEV1\<50%), PVD, and/or Anemia
- End-stage malignancy
- Severe valvular heart disease
- Psychiatric hospitalization within the last 3 months
- Chronic ETOH or drug dependency.
- We will exclude all of the following special populations:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
June 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06576297
Start Date
June 30 2024
End Date
February 28 2026
Last Update
July 4 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213