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Completed

NCT Number: NCT02301689

SchlaHF-XT-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?

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Key information

Conditions

Heart Failure (HF) Apnea Cardiovascular Diseases Dyssomnias Heart Diseases Heart Failure Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart and Diabetes Centre

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 26, 2014
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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