Skip to main content
OpenTrials
Completed

NCT Number: NCT01896661

Effect of Antihypertensive Agents Over Sleep Apnea

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Apnea Cardiovascular Diseases Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diuretics

Drug

Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning

Other names: Chlorthalidone/Amiloride

Calcium Channel Blockers

Drug

Amlodipine 10 mg daily, taking in the morning

Other names: Amlodipine

Primary outcomes

  1. Apnea-Hypopnea Index

    Time frame: 8 weeks

    Number of apneas/hour

  2. Blood Pressure

    Time frame: 8 weeks

Secondary outcomes

  1. Adverse events

    Time frame: 8 weeks

  2. Somnolence scale (Epworth) and ventilatory parameters

    Time frame: 8 weeks

  3. C reactive protein

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 11, 2013
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.