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NCT03226652 Clinical Trial

Heart Function in Patients Assessed for Sleep Apnoea

Heart Failure Clinical Trial

Official title:
Heart Function in Patients Assessed for Sleep Disordered Breathing (SDB)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03226652
Other study ID # 17IC3980
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 24, 2017
Est. completion date April 1, 2019

Study information
Verified date February 2021
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Aged =40 years and referred for respiratory polygraphy Exclusion Criteria: - Previous diagnosis of Heart Failure - Treated sleep disordered breathing

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Brompton Hospital London

Sponsors (2)
Lead Sponsor Collaborator
Imperial College London Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB) 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. Baseline
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