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

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Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures

Secondary Outcome

 Change in measurements of diastolic function after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures.

Condition

Dilated Cardiomyopathy

Intervention

Continues Positive Airway Pressure (CPAP)

Study Arms / Comparison Groups

 Continues Positive Airway Pressure
Description:  Use of Continues Positive Airway Pressure (CPAP) mask every night under six months period.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

44

Start Date

November 2014

Completion Date

December 2019

Primary Completion Date

December 2018

Eligibility 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
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, +46313434085, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT02989181

Organization ID

FoU127221


Responsible Party

Principal Investigator

Study Sponsor

Göteborg University


Study Sponsor

, , 


Verification Date

March 2018