Heart Failure Clinical Trial

Sleep Apnea in Heart Failure With Preserved Ejection Fraction

Summary

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.

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Full Description

This is a prospective non-randomized observational study which will recruit patients with gold standard HFpEF defined by exercise catheterization or following HF hospitalization. The prevalence of OSA will be determined in all HFpEF patients at baseline using home sleep apnea testing and all patients will complete the Mayo Sleep Questionnaire. Patients with known OSA at baseline will also be included only for the baseline assessment to accurately estimate prevalence of OSA in gold standard diagnosed HFpEF. The subset of initially recruited patients with HFpEF who have newly diagnosed OSA will be offered and initiated on CPAP therapy to treat their underlying OSA. Repeat evaluation after 3 months of CPAP therapy for end point assessment with remote accelerometry (2 weeks prior to study completion), ESS and KCCQ, which will all be identical to baseline measurements.

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Eligibility Criteria

Inclusion Criteria:

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)

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

Study is for people with:

Heart Failure

Estimated Enrollment:

60

Study ID:

NCT05008432

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic Rochester
Rochester Minnesota, 55905, United States More Info
Colleen M Irlbeck
Contact
507-266-6879
[email protected]
Yogesh N Reddy, MBBS
Principal Investigator

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Study is for people with:

Heart Failure

Estimated Enrollment:

60

Study ID:

NCT05008432

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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