Trial Outcomes & Findings for Heart Function in Patients Assessed for Sleep Apnoea (NCT NCT03226652)

NCT ID: NCT03226652

Last Updated: 2021-02-17

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 101 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-02-17

Participant Flow

Participant milestones

Measure	Patients With Clinically Suspected Sleep Disordered Breathing (SDB) Patients with clinically suspected SDB investigated with respiratory polygraphy.
Overall Study STARTED	101
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients With Clinically Suspected Sleep Disordered Breathing (SDB) n=101 Participants Patients with clinically suspected SDB investigated with respiratory polygraphy.
Age, Continuous	60.0 years STANDARD_DEVIATION 10.1 • n=101 Participants
Sex: Female, Male Female	42 Participants n=101 Participants
Sex: Female, Male Male	59 Participants n=101 Participants
Region of Enrollment United Kingdom	101 participants n=101 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With Clinically Suspected Sleep Disordered Breathing (SDB) n=101 Participants Patients with clinically suspected SDB investigated with respiratory polygraphy.
Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB)	7 Participants

Adverse Events

Patients With Clinically Suspected Sleep Disordered Breathing (SDB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor M Cowie

Imperial College London

Phone: +44 (0)207 3518856

Email: m.cowie@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place