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Effect of Continuous Positive Airway Pressure (CPAP) Treatment in the Control of Refractory Hypertension

NCT00616265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2012-02-29

No results posted yet for this study

Summary

The working hypothesis for the present study is that treatment with CPAP in patients with an sleep apnea (IAH\>15) and AHT-r is capable of producing significant reductions in blood-pressure levels.

This hypothesis is supported by four proven findings:

1. -sleep apnea is an independent risk factor for arterial hypertension (1).
2. -The greater the number of RSD, the greater the loss of control over blood-pressure levels (1).
3. -The prevalence of sleep apnea in patients with AHT refractory to treatment is very high (11,12).
4. -Treatment of patients with sleep apnea and AHT-r with CPAP succeeds in significantly reducing blood-pressure levels in the only (small-scale) studies undertaken to date (14,15).

4\. OBJECTIVES

Main objective:

To evaluate the effect of treatment with CPAP on blood-pressure levels in patients with AHT refractory to medical treatment.

Secondary objectives:

* To evaluate the effect of treatment with CPAP on the various elements assessed in BP (systolic/diastolic; daytime/nighttime, etc) and the circadian profile (dipper/non-dipper/raiser patterns; variability and homogeneity of blood-pressure levels, etc) obtained during a 24-hour out-patient study (AMPA).
* To analyze the related variables or subgroups of patients most affected by treatment with CPAP.
* To evaluate the effect of CPAP on the levels of some of the biological variables involved in the pathogenesis of AHT-r (renin, angiotensin, aldosterone, atrial natriuretic factor, etc).

Conditions

Interventions

DEVICE

CPAP

Pressure device on airway to maintain it open

Sponsors & Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

    lead OTHER

Principal Investigators

  • Miguel Angel Martínez-Garcia, MD · Sociedad Española de Neumología y Cirugía Torácica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00616265 on ClinicalTrials.gov