Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00929175
First received: June 9, 2009
Last updated: February 24, 2014
Last verified: April 2013
  Purpose

Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.


Condition Intervention Phase
Hypertension
Device: active CPAP
Device: sham-CPAP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • aldosterone, renin, activated protein C [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active CPAP
auto-PAP with therapeutic pressure
Device: active CPAP
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
Sham Comparator: sham-CPAP
auto-PAP with pressure less than 1cm H2O
Device: sham-CPAP
The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O.

Detailed Description:

This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of resistant hypertension
  • Apnea/hypopnea index > 15

Exclusion Criteria:

  • Cardiac surgery on last 3 months
  • Serious arrhythmias
  • Insulin dependent diabetes
  • Debilitating neurological disease
  • severe COPD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929175

Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio grande do sul, Brazil, 90035003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Flavio D Fuchs Hospital de Clínicas de Porto Alegre
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00929175     History of Changes
Other Study ID Numbers: 07-020
Study First Received: June 9, 2009
Last Updated: February 24, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Hypertension
Resistant Hypertension
Sleep apnea syndrome
Treatment

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

ClinicalTrials.gov processed this record on April 14, 2014