Sleep Apnea in Heart Failure With Preserved Ejection Fraction

Last updated: August 27, 2024
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Sleep Apnea Syndromes

Treatment

Home sleep apnea testing

Clinical Study ID

NCT05008432
21-002139
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Diagnosis of HFpEF by catheterization with resting PCWP>15 mmHg or exercise PCWP>25mmHg or hospitalization with HFpEF

  • Ambulatory (not wheelchair/scooter dependent)

  • If no known diagnosis of OSA, must not be pacemaker dependent with either atrialpacing or VVI without sinus rhythm

  • If no known diagnosis of OSA, must be able to temporarily hold nitrates or alphachannel blockers for home WatchPAT testing (3 hour washout period)

Exclusion

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 Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Home sleep apnea testing
Phase:
Study Start date:
October 07, 2021
Estimated Completion Date:
July 24, 2024

Study 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.

Connect with a study center

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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