A Study to Evaluate Exercise Capacity and Positive Airway Pressure Impact on Sleep Apnea in Heart Failure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-002139
NCT ID: NCT05008432
About this study
The purpose of this study is to determine the prevalence of Obstructive Sleep Apnea (OSA) in HFpEF, and its clinical and hemodynamic correlates, and to determine the impact of intervention with CPAP therapy on exercise capacity and quality of life in HFpEF patients with OSA.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years.
- Diagnosis of HFpEF by catheterization with resting PCWP > 15 mmHg or exercise PCWP > 25 mmHg.
- If no known diagnosis of OSA, must not be pacemaker dependent with with either atrial pacing or VVI without sinus rhythm.
- If no known diagnosis of OSA, must be able to temporarily hold nitrates or alpha channel blockers for home WatchPAT testing.
Exclusion Criteria:
- Ejection fraction < 40%.
- Obstructive hypertrophic cardiomyopathy.
- Constrictive pericarditis or tamponade.
- Active myocarditis.
- Complex congenital heart disease.
- Other valve disease requiring surgical intervention.
- Terminal illness (other than HF) with expected survival of less than 1 year.
- Inability to comply with planned study procedures.
- Pregnancy or breastfeeding mothers.
Eligibility last updated 5/9/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yogesh Reddy, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available