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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02301689

Enrollment

4749

Registered

2014-11-26

Start date

2014-05-31

Completion date

2018-06-30

Last updated

2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure (HF)

Keywords

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

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?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5)	5 years	Assess the changes in prevalence of SDB in HF from baseline to 5 years

Secondary

Measure	Time frame	Description
Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment	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	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	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	5 years	Assess survival rates of HF patients who are treated for sleep disordered breathing

Countries

Germany

Outcome results