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NCT01896661

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

Completed Phase 3 Last updated 13 July 2016
What this trial tests

Phase 3 trial testing Diuretics in Hypertension in 53 participants. Completed in 1 February 2016.

Timeline
1 December 2014
Primary endpoint
1 December 2015
1 February 2016

Quick facts

Lead sponsorHospital de Clinicas de Porto Alegre
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment53
Start date1 December 2014
Primary completion1 December 2015
Estimated completion1 February 2016
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

40 and older, any sex, with Hypertension or Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial.
    Cichelero FT, Martinez D, Fuchs SC, Gus M, et al · · 2014 · cited 33× · PMID 24382030 · DOI 10.1186/1745-6215-15-1
  2. Effect of antihypertensive agents on sleep apnea and ambulatory blood pressure in patients with hypertension: A randomized controlled trial.
    Cichelero FT, Fuchs SC, Jorge JA, Martinez D, et al · · 2024 · cited 1× · PMID 38781664 · DOI 10.1016/j.sleep.2024.05.035
  3. Effects of chlorthalidone plus amiloride compared with amlodipine on short-term blood pressure variability in individuals with hypertension and obstructive sleep apnea: a randomized controlled trial.
    Lucca MB, Jorge JA, Cichelero FT, Martinez D, et al · · 2023 · PMID 37466401 · DOI 10.1097/mbp.0000000000000663

Verify or expand the search:

Other trials of Diuretics

Trials testing the same drug.

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other Hospital de Clinicas de Porto Alegre trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing