Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

NCT00765713 | Completed Phase 4

• 1 other identifier: HULP PI-719
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 3

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.

Conditions

Sleep Apnea; Ventricular Arrythmias; Systolic Left Ventricle Dysfunction

Keywords

Sleep apnea; CPAP; Ventricular arrhythmias; Defibrillator therapies

Outcome Measures

Primary Outcomes (1)

• Number of appropriate defibrillator therapies

  24 months

Secondary Outcomes (1)

• 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

  24 moths

Study Arms (2)

CPAP

EXPERIMENTAL

Continuous positive airway pressure

Device: Nasal continuous positive airway pressure

Conventional

NO INTERVENTION

Hygienic-dietetic recommendations

Interventions

Nasal continuous positive airway pressure DEVICE

Nocturnal

CPAP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• Hospital Virgen de la Salud: collaborator
• Hospital Universitario Virgen Macarena: collaborator

Study Sites (3)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, Spain

Location

Hospital Virgen de la Salud

Toledo, Toledo, Spain

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Francisco Garcia-Rio, PhD

  Hospital Universitario La Paz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 2, 2013

Record last verified: 2008-09

Locations

ES (3)