Central Sleep Apnea, Heart Failure, Heart Failure With Normal Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Obstructive Sleep Apnea, Sleep Disordered Breathing
Conditions
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.
Interventions
None listed
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥40 years and referred for respiratory polygraphy
Exclusion criteria
* Previous diagnosis of Heart Failure * Treated sleep disordered breathing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Clinically Suspected Sleep Disordered Breathing (SDB) Patients with clinically suspected SDB investigated with respiratory polygraphy. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Patients With Clinically Suspected Sleep Disordered Breathing (SDB) | — |
|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 10.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 101 participants | — |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 59 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Clinically Suspected Sleep Disordered Breathing (SDB) | Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB) | 7 Participants |