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

April 8, 2020 updated by: ResMed

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

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?

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4749

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Heart and Diabetes Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart Failure patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
5 years
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
5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

  • Principal Investigator: Olaf Oldenburg, MD, Heart and Diabetes Centre NRW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

November 23, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA120814

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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