NCT05008432Completed
Sleep Apnea in Heart Failure With Preserved Ejection Fraction
Sleep Apnea in Heart Failure With Preserved Ejection Fraction - Exercise Capacity and Impact of Positive Airway Pressure Therapy
Source: ClinicalTrials.gov · Last updated 28 Aug 2024
Brief summary (registry, in English)
This is a prospective interventional study to better understand i) the prevalence of Obstructive Sleep Apnea (OSA) in Heart Failure with preserved Ejection Fraction (HFpEF), ii) its hemodynamic correlates, and iii) the impact of intervention with Continuous Positive Airway Pressure (CPAP) on quality of life.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 48 (actual)
- First submitted
- 15 Jul 2021
- Start date
- 7 Oct 2021
- Primary completion date
- 24 Jul 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Heart failure
- NCT number
- NCT05008432
What you commit to
- Study type: Observational
- Participants enrolled: 48
- From 7 Oct 2021 to the primary completion date, 24 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Complex congenital heart disease
- Other valve disease requiring surgical intervention
- Terminal illness (other than HF) with expected survival of less than 1 year
Lab values
- Ejection fraction \<40%
Other
- Obstructive hypertrophic cardiomyopathy
- Constrictive pericarditis or tamponade
- Active myocarditis
- Inability to comply with planned study procedures
- Pregnancy or breastfeeding mothers
Who the study is looking for
- Age ≥ 18 years
- Diagnosis of HFpEF by catheterization with resting PCWP\>15 mmHg or exercise PCWP\>25 mmHg or hospitalization with HFpEF
- Ambulatory (not wheelchair/scooter dependent)
- If no known diagnosis of OSA, must not be pacemaker dependent 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 (3 hour washout period)
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.