Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT05008432
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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Notify Me18 year–99 year
All sexes
Observational
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be monitored with a WatchPAT device for home based diagnosis of OSA (for patients hospitalized with HFpEF, the sleep test may be performed in the hospital or at home).
Time frame: 6 months
Quality of life will be assessed by Kansas City Cardiomyopathy Questionnaire (Scale 0-100)
Time frame: 6 months
Average daily accelerometry units by wearable accelerometers (scale -1000 to 10000 units)
Time frame: 6 months
Hours of activity per day by wearable accelerometers (number of hours of activity per day range 0-12 hours)
Mayo Clinic
Other
Sleep Apnea in Heart Failure With Preserved Ejection Fraction - Exercise Capacity and Impact of Positive Airway Pressure Therapy
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