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Effect of Antihypertensive Agents Over Sleep Apnea

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01896661
Enrollment
53
Registered
2013-07-11
Start date
2014-12-31
Completion date
2016-02-29
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obstructive Sleep Apnea

Keywords

Sleep apnea, Hypertension, Treatment, Diuretics, Chlorthalidone, Amlodipine

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.

Interventions

Amlodipine 10 mg daily, taking in the morning

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

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Apnea-Hypopnea Index8 weeksNumber of apneas/hour
Blood Pressure8 weeks

Secondary

MeasureTime frame
Adverse events8 weeks
Somnolence scale (Epworth) and ventilatory parameters8 weeks
C reactive protein8 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026