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Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry (SchlaHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01500759
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
ResMed

Tracking Information
First Submitted Date December 23, 2011
First Posted Date December 28, 2011
Last Update Posted Date August 5, 2015
Study Start Date November 2007
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01500759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Official Title Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
Brief 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.

Detailed Description

Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure.

Sleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure.

Objective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF.

For this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate.

Cardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Weeks
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients with Chronic Heart Failure with LVEF ≤ 45% and NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 24 months.
Condition
  • Congestive Heart Failure
  • Left Ventricular Systolic Dysfunction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 4, 2015)
10775
Original Estimated Enrollment
 (submitted: December 23, 2011)
10000
Actual Study Completion Date May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01500759
Other Study ID Numbers 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ResMed
Study Sponsor ResMed
Collaborators Not Provided
Investigators
Principal Investigator: Erland Erdmann, Prof Klinikum der Universität zu Köln
Principal Investigator: Helmut Teschler, Prof Ruhrlandklinik Essen
Study Director: Holger Woehrle, MD ResMed
PRS Account ResMed
Verification Date August 2015