Heart Function in Patients Assessed for Sleep Apnoea

Completed

• Conditions: Obstructive Sleep Apnea; Heart Failure; Heart Failure With Preserved Ejection Fraction; Sleep Disordered Breathing; Heart Failure With Normal Ejection Fraction; Central Sleep Apnea

• Registration Number: NCT03226652
• Lead Sponsor: Imperial College London

Brief Summary

This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).

Detailed Description

Patients with sleep disordered breathing (SDB) and those with heart failure with preserved ejection fraction (HFpEF) share similar characteristics. Increasing age, hypertension, obesity, diabetes mellitus and atrial fibrillation are well recognised links in both groups. It also known that SDB is common in patients with heart failure, both with reduced and preserved ejection fraction. It is therefore hypothesised that among patients being referred for SDB assessment, we can identify a group with unrecognised HFpEF.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study Start: 2017-07-24
• Study First Posted: 2017-07-24
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Results First Submitted: 2021-01-21
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Results First Posted: 2021-02-17
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Aged ≥40 years and referred for respiratory polygraphy

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Exclusion Criteria

• Previous diagnosis of Heart Failure
• Treated sleep disordered breathing

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB)	Baseline	The diagnosis of HFpEF was established using criteria set out in the European Society for Cardiology (ESC) guidelines based on clinical symptoms and/or signs, biomarker analysis (NT-proBNP) and evidence of structural cardiac remodeling or diastolic dysfunction on transthoracic echocardiography.

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom