Sleep Apnea in Heart Failure With Preserved Ejection Fraction

NCT05008432 | Completed

• 1 other identifier: 21-002139
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (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

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

  6 months

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

Home sleep apnea testing DIAGNOSTIC_TEST

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).

HFpEF Patients Diagnosed with Obstructive Sleep Apnea

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients with preserved ejection fraction.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Itamar-Medical, Israel: collaborator
• Sleep Number Corporation: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Heart Failure; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yogesh Reddy, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 17, 2021
• Study Start: October 7, 2021
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (1)