Effect of Antihypertensive Agents Over Sleep Apnea

Study Overview
=================
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.

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

Conditions
-----------------
Hypertension, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Drug: Diuretics
* Drug: Calcium Channel Blockers


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diuretics<br>Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning | Drug: Diuretics<br>* Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning<br>* Other names: Chlorthalidone/Amiloride;|
| Active Comparator: Calcium Channel Blockers<br>Amlodipine 10 mg daily, taking in the morning | Drug: Calcium Channel Blockers<br>* Amlodipine 10 mg daily, taking in the morning<br>* Other names: Amlodipine;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Sleep apnea, Treatment, Diuretics, Chlorthalidone, Amlodipine