NCT01896661

Effect of Antihypertensive Agents Over Sleep Apnea

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Obstructive Sleep Apnea

Interventions

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

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2013-07-11
• Last updated: 2016-07-14

Locations

1 site across 1 country: Brazil