Effect of Antihypertensive Agents Over Sleep Apnea

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Completed

CT.gov ID

NCT01896661

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Obstructive Sleep Apnea	Drug: Diuretics Drug: Calcium Channel Blockers	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Apnea-Hypopnea Index [8 weeks]
Number of apneas/hour
Blood Pressure [8 weeks]

Secondary Outcome Measures

Adverse events [8 weeks]
Somnolence scale (Epworth) and ventilatory parameters [8 weeks]
C reactive protein [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS	Brazil	90035-903

Sponsors and Collaborators

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