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

Hypertension Clinical Trial

Official title:

Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929175
• Other study ID #: 07-020
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2009
• Last updated: February 24, 2014
• Start date: February 2008
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• active CPAP
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio grande do sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring		8 weeks after treatment	No
Secondary	aldosterone, renin, activated protein C		8 weeks	No