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Effect of Antihypertensive Agents Over Sleep Apnea

Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Obstructive Sleep Apnea

Intervention: Diuretics (Drug); Calcium Channel Blockers (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hospital de Clinicas de Porto Alegre

Official(s) and/or principal investigator(s):
Flavio D Fuchs, MD, PhD, Study Chair, Affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Fabio T Cichelero, MD, Principal Investigator, Affiliation: Federal University of Rio Grande do Sul

Overall contact:
Flavio D Fuchs, MD, PhD, Phone: 3359-8420, Email: ffuchs@hcpa.ufrgs.br

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.

Clinical Details

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

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

Primary outcome:

Apnea-Hypopnea Index

Blood Pressure

Secondary outcome:

Adverse events

Somnolence scale (Epworth) and ventilatory parameters

C reactive protein

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.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients older than 40 years of age

- Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30

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

Locations and Contacts

Flavio D Fuchs, MD, PhD, Phone: 3359-8420, Email: ffuchs@hcpa.ufrgs.br

Hospital de Clinicas de Porto Alegre, Porto Alegre, RS 90035-903, Brazil; Recruiting
Additional Information

Starting date: December 2014
Last updated: April 16, 2015

Page last updated: August 23, 2015

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