Effect of Antihypertensive Agents Over Sleep Apnea
Primary Purpose
Hypertension, Obstructive Sleep Apnea
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Diuretics
Calcium Channel Blockers
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Sleep apnea, Hypertension, Treatment, Diuretics, Chlorthalidone, Amlodipine
Eligibility 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
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diuretics
Calcium Channel Blockers
Arm Description
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Amlodipine 10 mg daily, taking in the morning
Outcomes
Primary Outcome Measures
Apnea-Hypopnea Index
Number of apneas/hour
Blood Pressure
Secondary Outcome Measures
Adverse events
Somnolence scale (Epworth) and ventilatory parameters
C reactive protein
Full Information
NCT ID
NCT01896661
First Posted
July 8, 2013
Last Updated
July 13, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01896661
Brief Title
Effect of Antihypertensive Agents Over Sleep Apnea
Official Title
The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obstructive Sleep Apnea
Keywords
Sleep apnea, Hypertension, Treatment, Diuretics, Chlorthalidone, Amlodipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diuretics
Arm Type
Experimental
Arm Description
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Arm Title
Calcium Channel Blockers
Arm Type
Active Comparator
Arm Description
Amlodipine 10 mg daily, taking in the morning
Intervention Type
Drug
Intervention Name(s)
Diuretics
Other Intervention Name(s)
Chlorthalidone/Amiloride
Intervention Description
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Intervention Type
Drug
Intervention Name(s)
Calcium Channel Blockers
Other Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine 10 mg daily, taking in the morning
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
Number of apneas/hour
Time Frame
8 weeks
Title
Blood Pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
8 weeks
Title
Somnolence scale (Epworth) and ventilatory parameters
Time Frame
8 weeks
Title
C reactive protein
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio D Fuchs, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabio T Cichelero, MD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24382030
Citation
Cichelero FT, Martinez D, Fuchs SC, Gus M, Moreira LB, Fuchs FD. The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial. Trials. 2014 Jan 2;15:1. doi: 10.1186/1745-6215-15-1.
Results Reference
derived
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Effect of Antihypertensive Agents Over Sleep Apnea
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