Sleep Apnea in Heart Failure With Preserved Ejection Fraction

Heart Failure Clinical Trial

Official title:

Sleep Apnea in Heart Failure With Preserved Ejection Fraction - Exercise Capacity and Impact of Positive Airway Pressure Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008432
• Other study ID #: 21-002139
• Status: Recruiting
• Start date: October 7, 2021
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Colleen M Irlbeck
• Phone: 507-266-6879
• Email: Irlbeck.Colleen[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Heart Failure
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Home sleep apnea testing
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).

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Itamar-Medical, Israel, Sleep Number Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the impact of intervention with CPAP therapy on quality of life as assessed by Kansas City Cardiomyopathy Questionnaire scores (Scale 0-100) in patients with Obstructive Sleep Apnea at Baseline	Quality of life will be assessed by Kansas City Cardiomyopathy Questionnaire (Scale 0-100)	6 months
Secondary	Determine the impact of intervention with CPAP therapy on average daily accelerometry units (scale -1000 to 10000 units) by wearable accelerometers in patients with Obstructive Sleep Apnea at Baseline	Average daily accelerometry units by wearable accelerometers (scale -1000 to 10000 units)	6 months
Secondary	Determine the impact of intervention with CPAP therapy on hours active per day (number of hours of activity per day range 0-12 hours) by wearable accelerometers in patients with Obstructive Sleep Apnea at Baseline	Hours of activity per day by wearable accelerometers (number of hours of activity per day range 0-12 hours)	6 months

External Links

•   Mayo Clinic Clinical Trials