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

Heart Failure (HF) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301689
• Other study ID #: MA120814
• Status: Completed
• Start date: May 2014
• Est. completion date: June 2018

Study information

• Verified date: April 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4749
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure (HF)
• Respiratory Aspiration
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
Germany	Heart and Diabetes Centre	Bad Oeynhausen	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment	Assess changes in sleep disordered breathing when exposed to treatment from baseline to 5 years	5 years
Secondary	Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment	Assess changes in SDB when the patient is treated with heart failure therapy	5 years
Secondary	Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours	Assess adherence rates to treatment	5 years
Secondary	Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing	Assess survival rates of HF patients who are treated for sleep disordered breathing	5 years