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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: Home sleep apnea testing

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients with preserved ejection fraction.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HFpEF Patients Diagnosed with Obstructive Sleep Apnea; Right heart cath patients who are diagnosed with HFpEF will undergo a home sleep apnea test (for patients hospitalized with HFpEF, the initial home sleep test will be performed in hospital overnight)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Itamar-Medical, Israel; Sleep Number Corporation
• Investigators: Principal Investigator: Yogesh Reddy, M.B.B.S., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Heart Failure; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 21-002139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No