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

NCT02301689 | Completed

• 1 other identifier: MA120814
• Study Type: observational
• Target: 4,749
• Locations: 1 country
• Sites: 1

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?

Conditions

Heart Failure (HF)

Keywords

Heart failure; Chronic heart failure; Sleep disordered breathing; Sleep apnea; Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5)

  Assess the changes in prevalence of SDB in HF from baseline to 5 years

  5 years

Secondary Outcomes (4)

• Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment

  5 years

• Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment

  5 years

• Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours

  5 years

• Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing

  5 years

Study Arms (1)

Heart Failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Heart and Diabetes Centre

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

• Arzt M, Oldenburg O, Graml A, Schnepf J, Erdmann E, Teschler H, Schoebel C, Woehrle H; SchlaHF-XT investigators. Prevalence and predictors of sleep-disordered breathing in chronic heart failure: the SchlaHF-XT registry. ESC Heart Fail. 2022 Dec;9(6):4100-4111. doi: 10.1002/ehf2.14027. Epub 2022 Sep 2.

  PMID: 36052740 DERIVED

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Olaf Oldenburg, MD

  Heart and Diabetes Centre NRW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: November 26, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

DE (1)