N/A
N=6,876
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Congestive Heart Failure · Left Ventricular Systolic Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01500759 ↗Enrolled (actual)
6,876
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Prevalence of SDB in Chronic HF Patients — 3190 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of SDB in Chronic HF Patients |
3190 | — |
| SECONDARY Left Ventricular Ejection Fraction |
33.6; 32.8 | — |
| SECONDARY Age |
65; 69 | — |
| SECONDARY Body Mass Index |
28.1; 28.9 | — |
| SECONDARY Male Gender |
2754; 2674 | — |
| SECONDARY NYHA Class ≥III |
2566; 2341 | — |
| SECONDARY Ischemic Etiology |
1961; 1742 | — |
| SECONDARY Atrial Fibrillation |
863; 1001 | — |
| SECONDARY Nocturnal Dyspnea |
672; 800 | — |
| SECONDARY Nocturia ≥3 Times/Night |
580; 660 | — |
| SECONDARY Apnoea-Hypopnea-Index |
6; 31 | — |
| SECONDARY Oxygen Desaturation Index |
8; 24 | — |
| SECONDARY Mean SpO2 |
93; 92 | — |
| SECONDARY Min SpO2 |
83; 80 | — |
| SECONDARY Medication ACE Inhibitors and/ARBs |
3269; 2812 | — |
| SECONDARY Beta-blocker |
3284; 2824 | — |
| SECONDARY Diuretics |
2805; 2617 | — |
| SECONDARY Digitalis |
717; 599 | — |
| SECONDARY Aldosterone Antagonists |
1808; 1454 | — |
| SECONDARY Male Gender as Predictor for SDB in Chronic HF |
2754; 2674 | — |
| SECONDARY Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF |
863; 1001 | — |
| SECONDARY Ischemic Etiology as Predictor for SDB in Chronic HF |
1961; 1742 | — |
| SECONDARY NYHA Class >= III as Predictor for SDB in Chronic HF |
2566; 2341 | — |
Summary
Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.
For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.
Eligibility Criteria
Inclusion Criteria
- Patients must be over 18
- Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines
- Left ventricular systolic dysfunction (LVEF ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks
- NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
- Patient is able to fully understand study information and signed informed consent
Exclusion Criteria
- Life expectancy < 1 year for diseases unrelated to chronic HF
- Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months
- CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months
- Transient ischemic attack (TIA) or Stroke within 3 months
- Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery
- Acute myocarditis/pericarditis within 6 months
- Current CPAP or bilevel therapy
Data sourced from ClinicalTrials.gov (NCT01500759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.