Effect of Antihypertensive Agents Over Sleep Apnea

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896661
• Other study ID #: 07572112.7.0000.5327
• Secondary ID: 12-0417
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2013
• Last updated: July 13, 2016
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Diuretics
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
• Calcium Channel Blockers
Amlodipine 10 mg daily, taking in the morning

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index	Number of apneas/hour	8 weeks	No
Primary	Blood Pressure		8 weeks	No
Secondary	Adverse events		8 weeks	Yes
Secondary	Somnolence scale (Epworth) and ventilatory parameters		8 weeks	No
Secondary	C reactive protein		8 weeks	No