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SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register

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: NCT02301689
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
ResMed

Tracking Information
First Submitted Date September 17, 2014
First Posted Date November 26, 2014
Last Update Posted Date November 3, 2016
Study Start Date May 2014
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2014)
Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5) [ Time Frame: 5 years ]
Assess the changes in prevalence of SDB in HF from baseline to 5 years
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02301689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 23, 2014)
  • Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment [ Time Frame: 5 years ]
    Assess changes in sleep disordered breathing when exposed to treatment from baseline to 5 years
  • Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment [ Time Frame: 5 years ]
    Assess changes in SDB when the patient is treated with heart failure therapy
  • Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours [ Time Frame: 5 years ]
    Assess adherence rates to treatment
  • Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing [ Time Frame: 5 years ]
    Assess survival rates of HF patients who are treated for sleep disordered breathing
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register
Official Title SchlaHF-XF- Register. Sleep Disordered Breathing in Heart Failure Register
Brief Summary

The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions:

How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment adherence of patients treated? Does SBD and its treatment affect the survival of heart failure patients?

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population is patients with Heart failure (HF). HF is defined as a symptom complex of shortness of breath and rapid fatigability on the basis of cardiac disease (World Health Organisation).
Condition Heart Failure (HF)
Intervention Not Provided
Study Groups/Cohorts Heart Failure patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 2, 2016)
4749
Original Estimated Enrollment
 (submitted: November 23, 2014)
3000
Estimated Study Completion Date December 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnose chronic heart failure, at least 3 months prior to diagnosis
  • Age 18 years
  • Signed informed consent

Exclusion Criteria:

  • Existing Positive Airway Pressure (PAP) therapy or long-term oxygen therapy
  • Lack of capacity to consent
  • minors
  • persons who are housed on judicial or administrative order in an institution
  • pregnant and lactating women
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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02301689
Other Study ID Numbers MA120814
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: Olaf Oldenburg, MD Heart and Diabetes Centre NRW
PRS Account ResMed
Verification Date October 2016