Effect of Antihypertensive Agents Over Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01896661
First received: July 8, 2013
Last updated: July 13, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Hypertension
Obstructive Sleep Apnea
Drug: Diuretics
Drug: Calcium Channel Blockers
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Apnea-Hypopnea Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Number of apneas/hour

  • Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Somnolence scale (Epworth) and ventilatory parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • C reactive protein [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: December 2014
Study Completion Date: February 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diuretics
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Drug: Diuretics
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Other Name: Chlorthalidone/Amiloride
Active Comparator: Calcium Channel Blockers
Amlodipine 10 mg daily, taking in the morning
Drug: Calcium Channel Blockers
Amlodipine 10 mg daily, taking in the morning
Other Name: Amlodipine

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896661

Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Chair: Flavio D Fuchs, MD, PhD Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Principal Investigator: Fabio T Cichelero, MD Federal University of Rio Grande do Sul
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01896661     History of Changes
Other Study ID Numbers: 07572112.7.0000.5327  12-0417 
Study First Received: July 8, 2013
Last Updated: July 13, 2016
Health Authority: Brazil: National Committee of Ethics in Research
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
Sleep apnea
Hypertension
Treatment
Diuretics
Chlorthalidone
Amlodipine

Additional relevant MeSH terms:
Hypertension
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Calcium, Dietary
Amlodipine
Antihypertensive Agents
Chlorthalidone
Calcium Channel Blockers
Amiloride
Diuretics
Bone Density Conservation Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on August 30, 2016