Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias (SAHS-ICD)
| Tracking Information | |||||
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| First Received Date ICMJE | October 2, 2008 | ||||
| Last Updated Date | April 1, 2013 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of appropriate defibrillator therapies [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00765713 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
AHI, incidence of premature ventricular beats and non-sustained ventricular tachycardia. Plasmatic levels of C-reactive protein, homocystein, pro-BNP, sTNFαR-I, IL-1b, IL-2, IL-6, IL-8, IL-8 and 8-isoprostane [ Time Frame: 24 moths ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias | ||||
| Official Title ICMJE | Sleep Apnea-hypopnea Syndrome and Ventricular Arrhythmias in Patients With Systolic Ventricular Dysfunction and Implantable Cardioverter-defibrillator. Incidence and Effect of CPAP Treatment | ||||
| Brief Summary | Hypothesis: The CPAP treatment diminishes the effect of ventricular arrhythmias in patients with ischemic heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep apnea-hypopnea syndrome (SAHS)Objectives: To analyze the incidence of ventricular arrhythmias (premature ventricular beat, non-sustained ventricular tachycardia and sustained ventricular tachycardia) and appropriate defibrillator therapies in patients with ischemic heart disease or dilated myocardiopathy, moderate-severe left ventricular dysfunction,with an implantable cardioverter-defibrillator (ICD) and sleep apnea. To study the effect of CPAP on the cardiac arrhythmias and on the number of appropriate defibrillator therapies. Design: Parallel, randomized and single-blinded multicentric study to compare CPAP vs. hygienic-dietetic recommendations. Patients with SAHS (AHI≥15) and systolic left ventricle dysfunction patients with an ICD. Duration: 24 months. |
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| Detailed Description | Secondary objectives: To compare the prevalence of SAHS in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with ICD with that of the general population. To study the incidence of supraventricular arrhythmias (atrial fibrillation, atrial flutter or supraventricular tachycardia) and inappropriate defibrillator therapies in these patients. To value the effect of the treatment with CPAP on the above mentioned arrhythmias. To relate the effect of ventricular and supraventricular arrhythmias with sleep parameters, cardiovascular biomarkers, inflammation and oxidative stress. To evaluate the long-term effect of the CPAP on systemic biomarkers in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction. To evaluate the long-term effect of CPAP on the quality of life in these patients. Sample size: 224 patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with ICD will be included to randomize 19 SAHS subjects for arm. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Nasal continuous positive airway pressure
Nocturnal |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 224 | ||||
| Completion Date | January 2013 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00765713 | ||||
| Other Study ID Numbers ICMJE | HULP PI-719 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rafael Peinado Peinado, Hospital Universitario La Paz | ||||
| Study Sponsor ICMJE | Hospital Universitario La Paz | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Hospital Universitario La Paz | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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