NCT00404807

Brief Summary

The role of continuous positive airway pressure (CPAP) in cardiac function in patients with CSA and OSA has been studied with varying results. Nevertheless, it is not clear whether CPAP treatment for respiratory sleep disorders in CHF could slow down deterioration or improve the cardiovascular function. In an attempt to yield further insight into this subject, we undertook a multicentre study to analyze the role of CPAP therapy (optimal vs sham) in the LVEF and in other cardiac measurements in patients with CHF.Aim. We evaluated in a randomized multicentre placebo (sham-CPAP) controlled study the effect of CPAP treatment on the left ventricle ejection fraction (LVEF) among other cardiological related variables.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
Last Updated

November 29, 2006

Status Verified

November 1, 2006

First QC Date

November 28, 2006

Last Update Submit

November 28, 2006

Conditions

Sleep ApneaHeart FailureCardiovascular Diseases

Keywords

Continuous positive airway pressurecardiovascular diseasessleep apnea syndromessleep breathing disorderssham CPAP

Outcome Measures

Primary Outcomes (1)

  • Ejection fraction

Secondary Outcomes (6)

  • Hypertension

  • Daytime sleepiness

  • Quality of life (SF-36)

  • NewYork Heart Scale (NYHA score),

  • Dyspnea (by using the Borg scale)

  • +1 more secondary outcomes

Interventions

CPAP(Continuous Positive Airway Pressure)DEVICE

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • referral of patients with chronic heart failure to the sleep laboratory;
  • diagnosis of heart failure with at least one episode of cardiac failure;
  • LVEF less than 45% using radionuclide ventriculography;
  • optimum treatment with diuretics and/or beta-blockers and/or digoxin and/or ACE inhibitors according to tolerance
  • an Apnea-Hypopnea Index (AHI) greater than 10 measured by conventional polysomnography

You may not qualify if:

  • patients that had a previous diagnosis of OSA or had been exposed to CPAP therapy.
  • uncontrolled arterial hypertension;
  • valvular or congenital cardiopathy, unstable angina, acute myocardial infarction or cardiac surgery in the three months prior to enrolment;
  • severe somnolence defined as severe sleepiness in situations of activity;
  • present or past medical history of clinically significant renal, liver or pulmonary disease;
  • untreated hypothyroidism;
  • clinically significant kyphoscoliosis;
  • morbid obesity with a body mass index (BMI)\> 41 Kg/m2; and
  • concomitant use of the following drugs: morphine, hypnotics and sedatives, theophylline, acetazolamide or home oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesHeart FailureCardiovascular Diseases

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Carlos Egea-Santaolalla, MD

    Hospital Universitario Txagorritxu. Vitoria Gasteiz. Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 29, 2006

Study Start

January 1, 2001

Study Completion

June 1, 2004

Last Updated

November 29, 2006

Record last verified: 2006-11

Locations

ES(1)