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Sleep Apnea and Refractory Hypertension: Prevalence and Effect of CPAP Treatment

This study has been completed.
Sponsor:
Information provided by:
Fundacio Catalana de Pneumologia
ClinicalTrials.gov Identifier:
NCT00459914
First received: April 11, 2007
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term.

The purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.


Condition Intervention Phase
Hypertension
Sleep Apnea
Device: cpap treatment during sleep
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Sleep Apnea in Patients With Refractory Hypertension: Study of the Prevalence and the Effect of CPAP Treatment on Blood Pressure Control, Endothelial Dysfunction and Angiogenesis.

Resource links provided by NLM:


Further study details as provided by Fundacio Catalana de Pneumologia:

Primary Outcome Measures:
  • Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure . [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 CPAP
Nasal continuous positive airway pressure
Device: cpap treatment during sleep
CPAP
No Intervention: 2
Pharmacological treatment alone

Detailed Description:

We assess the prevalence of an apnea hypopnea index (AHI) > 5 in patients with refractory hypertension referred from a hypertension clinic. Patients with an AHI >15 are randomized to either continuing their usual pharmacological treatment alone or adding CPAP to their usual treatment, during a 3 month period.

The main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as assessed by ambulatory blood pressure monitoring, between both treatment arms. The secondary endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmHg despite the recommended doses of at least 3 drugs, including a diuretic.

Exclusion Criteria:

  • Causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00459914

Locations
Spain
Servei de Pneumologia, Hosital general Universitari Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Fundacio Catalana de Pneumologia
Investigators
Principal Investigator: Lourdes Lozano, MD Hospital General Universitari Vall d'Hebron
Study Chair: Jose Luis Tovar, MD Hospital General Universitari Vall d'Hebron
Study Chair: Gabriel Sampol, MD Hospital General Universitari Vall d'Hebron
Study Chair: Odile Romero, MD Hospital General Universitari Vall d'Hebron
Study Chair: Pilar Chacon, MD Hospital General Universitari Vall d'Hebron
Study Chair: Jose Rios Universitat Autonoma de Barcelona
  More Information

No publications provided

Responsible Party: Ferran Morell, Fundacio Catalana de Pneumologia
ClinicalTrials.gov Identifier: NCT00459914     History of Changes
Other Study ID Numbers: FUCAP2004
Study First Received: April 11, 2007
Last Updated: January 27, 2009
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Fundacio Catalana de Pneumologia:
sleep apnea
refractory hypertension
continuous positive airway pressure

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Cardiovascular Diseases
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014