Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias (SAHS-ICD)

April 1, 2013 updated by: Hospital Universitario La Paz

Sleep Apnea-hypopnea Syndrome and Ventricular Arrhythmias in Patients With Systolic Ventricular Dysfunction and Implantable Cardioverter-defibrillator. Incidence and Effect of CPAP Treatment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Sevilla, Spain
        • Hospital Universitario Virgen de la Macarena
      • Toledo, Spain
        • Hospital Virgen de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous diagnostic of ischaemic heart disease of dilated myocardiopathy
  • Ejection fraction of left ventricle < 40%
  • Patients with implantable cardioverter-defibrillator

Exclusion Criteria:

  • Diurnal hypersomnolence with EES > 16
  • Morbid obesity (BMI > 35 Kg/m2).
  • Moderate-severe chronic obstructive pulmonary disease (FEV1/FVC < 70 % and FEV1 < 80 % of reference).
  • Known thyroid disease.
  • Previous treatment with CPAP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CPAP
Continuous positive airway pressure
Device: Nasal continuous positive airway pressure
Nocturnal
NO_INTERVENTION: Conventional
Hygienic-dietetic recommendations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of appropriate defibrillator therapies
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
24 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario La Paz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario Virgen Macarena
Hospital Virgen de la Salud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Francisco Garcia-Rio, PhD, Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HULP PI-719

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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