Sleep Apnea in Heart Failure With Preserved Ejection Fraction

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05008432
• Collaborator: Itamar-Medical, Israel (Industry), Sleep Number Corporation (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 23.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Obstructive Sleep Apnea	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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sleep Apnea in Heart Failure With Preserved Ejection Fraction - Exercise Capacity and Impact of Positive Airway Pressure Therapy
• Actual Study Start Date: Oct 7, 2021
• Anticipated Primary Completion Date: Jul 25, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	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 initial home sleep test will be performed in hospital overnight).

Outcome Measures

Primary Outcome Measures

1. 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 [6 months]

   Quality of life will be assessed by Kansas City Cardiomyopathy Questionnaire (Scale 0-100)

Secondary Outcome Measures

1. 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 [6 months]

   Average daily accelerometry units by wearable accelerometers (scale -1000 to 10000 units)

2. 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 [6 months]

   Hours of activity per day by wearable accelerometers (number of hours of activity per day range 0-12 hours)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Itamar-Medical, Israel
• Sleep Number Corporation

Investigators

• Principal Investigator: Yogesh Reddy, M.B.B.S., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Yogesh N. V. Reddy, M.B.B.S., Assistant Professor of Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05008432
• Other Study ID Numbers: 21-002139
• First Posted: Aug 17, 2021
• Last Update Posted: Apr 8, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Heart Failure

Study Results

No Results Posted as of Apr 8, 2022