Effect of Antihypertensive Agents Over Sleep Apnea

Phase 3

Completed

• Conditions: Hypertension; Obstructive Sleep Apnea
• Interventions: Drug: Diuretics; Drug: Calcium Channel Blockers

• Registration Number: NCT01896661
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diuretics	Diuretics	Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Calcium Channel Blockers	Calcium Channel Blockers	Amlodipine 10 mg daily, taking in the morning

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index	8 weeks	Number of apneas/hour
Blood Pressure	8 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	8 weeks
Somnolence scale (Epworth) and ventilatory parameters	8 weeks
C reactive protein	8 weeks

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil