Effect of Antihypertensive Agents Over Sleep Apnea | NCT01896661

Studies
Effect of Antihypertensive Agents Over Sleep Apnea

NCT01896661

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Completed

Last Update Posted

Jul 14, 2016Estimated

Enrollment

53Actual

Phase

Phase 3

Conditions

Hypertension
Obstructive Sleep Apnea

Interventions

Diuretics
Calcium Channel Blockers

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
12-0417	Other Identifier	WebGPPG

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jul 8, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diuretics	Experimental	Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning	Drug: Diuretics
Calcium Channel Blockers	Active Comparator	Amlodipine 10 mg daily, taking in the morning	Drug: Calcium Channel Blockers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diuretics	Drug	Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning	Diuretics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Apnea-Hypopnea Index	Number of apneas/hour	8 weeks
Blood Pressure		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse events		8 weeks
Somnolence scale (Epworth) and ventilatory parameters		8 weeks
C reactive protein

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Flavio D Fuchs, MD, PhD	Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul	Study Chair
Fabio T Cichelero, MD	Federal University of Rio Grande do Sul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clinicas de Porto Alegre		Porto Alegre	Rio Grande do Sul	90035-903	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38781664	Derived	Cichelero FT, Fuchs SC, Jorge JA, Martinez D, Oliveira GPF, Lucca MB, Oliveira ACT, Fuchs FD. Effect of antihypertensive agents on sleep apnea and ambulatory blood pressure in patients with hypertension: A randomized controlled trial. Sleep Med. 2024 Jul;119:417-423. doi: 10.1016/j.sleep.2024.05.035. Epub 2024 May 16.
24382030

ID	Term
D006973	Hypertension
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001049	Apnea
D012120	Respiration Disorders

ID	Term
D004232	Diuretics
D002752	Chlorthalidone
D000584	Amiloride
D002121	Calcium Channel Blockers
D017311	Amlodipine

ID	Term
D045283	Natriuretic Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses