Effect of Antihypertensive Agents Over Sleep Apnea

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01896661
First received: July 8, 2013
Last updated: July 10, 2013
Last verified: June 2013
  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: Chlorthalidone/Amiloride
Drug: Amlodipine
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 ]

Estimated Enrollment: 58
Study Start Date: August 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diuretic
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Drug: Chlorthalidone/Amiloride
Active Comparator: Amlodipine
Amlodipine 10 mg daily, taking in the morning
Drug: 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
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 (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
  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

Contacts
Contact: Flavio D Fuchs, MD, PhD 3359-8420 ffuchs@hcpa.ufrgs.br
Contact: Fabio T Cichelero, MD fabio@cichelero.com

Locations
Brazil
Hospital de Clinicas de Porto Alegre Not yet recruiting
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

No publications provided by Hospital de Clinicas de Porto Alegre

Additional 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 10, 2013
Health Authority: Brazil: Ethics Committee

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 Disorders
Nervous System Diseases
Amlodipine
Antihypertensive Agents
Chlorthalidone
Amiloride
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Acid Sensing Ion Channel Blockers

ClinicalTrials.gov processed this record on September 18, 2014