Effect of Antihypertensive Agents Over Sleep Apnea

July 13, 2016 updated by: Hospital de Clinicas de Porto Alegre

The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial

Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, clinical trial, comparing the association of Chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). The primary outcomes will be the variation of apneas/hour and blood pressure. The secondary outcomes will be adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein. The follow up will last 8 weeks. The sample size will be of 29 participants per group. The project was approved by the Ethics committee of our institution.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 40 years of age
  • Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)

Exclusion Criteria:

  • Low life expectancy
  • Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs
  • Pregnancy
  • Established cardiovascular disease (myocardial infarction
  • Stroke
  • Heart failure)
  • Use of more than one drug for hypertension
  • Secondary hypertension
  • Participation in other clinical trial in previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diuretics
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Drug: Diuretics
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Other Names:
  • Chlorthalidone/Amiloride
Active Comparator: Calcium Channel Blockers
Amlodipine 10 mg daily, taking in the morning
Drug: Calcium Channel Blockers
Amlodipine 10 mg daily, taking in the morning
Other Names:
  • Amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 8 weeks
8 weeks
Apnea-Hypopnea Index
Time Frame: 8 weeks
Number of apneas/hour
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 8 weeks
8 weeks
Somnolence scale (Epworth) and ventilatory parameters
Time Frame: 8 weeks
8 weeks
C reactive protein
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Study Chair: Flavio D Fuchs, MD, PhD, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
  • Principal Investigator: Fabio T Cichelero, MD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07572112.7.0000.5327
  • 12-0417 (Other Identifier: WebGPPG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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