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Trial record 39 of 157 for:    Idiopathic Dilated Cardiomyopathy

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

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ClinicalTrials.gov Identifier: NCT02989181
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Schaufelberger, Göteborg University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Obstructive Sleep Apnea Device: Continues Positive Airway Pressure (CPAP) Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Continues Positive Airway Pressure Treatment in Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea (RIDA)
Study Start Date : November 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


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...



Primary Outcome Measures :
  1. Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures [ Time Frame: 6 months ]
    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.

  2. Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in measurements of diastolic function after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures. [ Time Frame: baseline and at six months ]
    Secondary outcomes include measurements of diastolic function measured by cardiac magnetic resonance (CMR) and echocardiography,

  2. Change in measurements of cardiovascular biomarkers at [ Time Frame: baseline and at six months ]
    Analyzing change in cardiovascular biomarkers by analyzing blood samples

  3. Change in quality of life questioners [ Time Frame: baseline and at six months ]
    Analyzing participants response to quality of life by analyzing established questioners regarding dilated cardiomyopathy (Kansas city cardiomyopathy questionnaire KCCQ).

  4. Change in day-time sleepiness [ Time Frame: baseline and at six month ]
    Analyzing participants respons to established questioners regarding sleep apnea (Epworth sleepiness scale ESS) and



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989181


Contacts
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Contact: Maria Schaufelberger, Associate Professor +46313434085 maria.schaufelberger@gu.se
Contact: Carmen Basic, MD +46704807426 carmen.basic@gu.se

Locations
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Sweden
Sahlgrenska University Hospital/Östra Recruiting
Gothenburg, Sweden, 41678
Contact: Maria Schaufelberger, Assoc.Prof.    +46313434085    maria.schaufelberger@gu.se   
Contact: Carmen Basic, MD    +46704807426    carmen.basic@gu.se   
Sub-Investigator: Erik Thunström, MD, PhD         
Sub-Investigator: Yuksel Peker, Professor         
Sponsors and Collaborators
Göteborg University

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Responsible Party: Maria Schaufelberger, Associate Professor, Göteborg University
ClinicalTrials.gov Identifier: NCT02989181     History of Changes
Other Study ID Numbers: FoU127221
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Cardiomegaly