Heart Function in Patients Assessed for Sleep Apnoea

NCT03226652 | Completed Results

• 1 other identifier: 17IC3980
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with clinically suspected sleep disordered breathing (SDB)

Patients referred for Sleep disordered breathing assessment.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred from primary and secondary care for SDB assessment.

You may qualify if:

• Aged ≥40 years and referred for respiratory polygraphy

You may not qualify if:

• Previous diagnosis of Heart Failure
• Treated sleep disordered breathing

Sponsors & Collaborators

• Imperial College London: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Heart Failure

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Professor M Cowie
• Organization: Imperial College London

m.cowie@imperial.ac.uk

+44 (0)207 3518856

Study Officials

• Martin R Cowie, MD MSc

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: July 24, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)