Continues Positive Airway Pressure Treatment for Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea (RIDA)

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; Dilated Cardiomyopathy
• Intervention / Treatment: Device: Continues Positive Airway Pressure (CPAP)

Detailed Description

Sleep apnea, either obstructive (OSA) and central (CSA), occurs in more than half of all patients with heart failure (HF), and is associated with poor prognosis in these individuals.

Dilated cardiomyopathy (DCM) is the most common type of cardiomyopathy and is defined as the presence of the left ventricle dilatation and left ventricular systolic dysfunction without concurrent valvular or coronary artery disease. Its etiology is unclear, but a genetic component is present in at least 25% of cases. In younger individuals, the etiology is more heterogeneous, where a rare type of cardiomyopathy may occur in women in connection with pregnancy, s.c. peripartum cardiomyopathy. Other underlying causes include alcohol, drugs, pharmaceuticals, endocrine disorders, systemic diseases and general muscle. These factors account for approximately half the cases of DCM in younger and other half designated as idiopathic (IDCM).

The relationship between cardiomyopathies and OSA is insufficiently studied so far. In a smaller population of 20 individuals with DCM, sleep apnea (OSA or CSA) had 16, ie 80% of patients. The first-line treatment of OSA is continues positive pressure breathing mask (CPAP) during sleep in patients with daytime sleepiness. Effect of CPAP therapy in patients with DCM and OSA is completely unknown, because many of them do not report daytime sleepiness. The fact that patients with heart failure and reduced pumping function usually have symptoms of including fatigue, it becomes difficult to distinguish what is fatigue due to heart failure and what is related to sleep apnea. Interpretation of the Epworth Sleepiness Scale (ESS) is thus difficult and possibly unsure why all patients with DCM and OSA will be randomized to treatment with CPAP.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41678
    • Recruiting
    • Sahlgrenska University Hospital/Östra
    • Contact: Carmen Basic, MD; Phone Number: +46704807426; Email: carmen.basic@gu.se
    • Contact: Maria Schaufelberger, Assoc.Prof.; Phone Number: +46313434085; Email: maria.schaufelberger@gu.se
    • Sub-Investigator: Erik Thunström, MD, PhD
    • Sub-Investigator: Yuksel Peker, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Continues Positive Airway Pressure; Use of Continues Positive Airway Pressure (CPAP) mask every night under six months period.	Device: Continues Positive Airway Pressure (CPAP); Mask with positive airway pressure during exhalation which maintains the airway open
NO_INTERVENTION: Consultation of conservative measures; Study participants with DCM and OSA (no-CPAP), participants receive consultation of conservative measures such as avoiding alcohol before bedrest, sleeping on the side...

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in measurements of cardiovascular biomarkers at	Analyzing change in cardiovascular biomarkers by analyzing blood samples	baseline and at six months
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
Change in day-time sleepiness	Analyzing participants respons to established questioners regarding sleep apnea (Epworth sleepiness scale ESS) and	baseline and at six month

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (ESTIMATE): December 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Genetic Diseases, Inborn; Signs and Symptoms, Respiratory; Cardiomegaly; Laminopathies; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: FoU127221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED