Obstructive Sleep Apnea Clinical Trial
— RIDAOfficial title:
Impact of Continues Positive Airway Pressure Treatment in Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea (RIDA)
The aim of this randomized controlled study is to investigate the effect of continues
positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and
concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function
measured by magnetic resonance (improvement of at least 4%) after six months treatment with
CPAP.
The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality
of life.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | December 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: Patients with newly diagnosed or previously known DCM, treated and followed at cardiology outpatients clinic, stable in their symptoms and functional class at least 2 weeks after the last medicine change. - Consent for the study. - EF = 45%. - OSA diagnosis (Apnea-Hypopnea index> = 15 in the sleep recording below). Exclusion Criteria: - Patients already treated with Continues Positive Airway Pressure. - Patients with claustrophobia |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital/Östra | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures | The primary endpoint is left ventricular ejection fraction (LVEF) measured by cardiac magnetic resonance (improvement of at least 4%) at study baseline and at 6 months after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures. | 6 months | |
Primary | Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures | The primary endpoint is left ventricular ejection fraction (LVEF) measured by echocardiography at study baseline and at 6 months after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures. | 6 months | |
Secondary | Change in measurements of diastolic function after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures. | Secondary outcomes include measurements of diastolic function measured by cardiac magnetic resonance (CMR) and echocardiography, | baseline and at six months | |
Secondary | Change in measurements of cardiovascular biomarkers at | Analyzing change in cardiovascular biomarkers by analyzing blood samples | baseline and at six months | |
Secondary | Change in quality of life questioners | Analyzing participants response to quality of life by analyzing established questioners regarding dilated cardiomyopathy (Kansas city cardiomyopathy questionnaire KCCQ). | baseline and at six months | |
Secondary | Change in day-time sleepiness | Analyzing participants respons to established questioners regarding sleep apnea (Epworth sleepiness scale ESS) and | baseline and at six month |
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