Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea (DOSA-2)

June 13, 2018 updated by: Hospital de Clinicas de Porto Alegre

Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea: Protocol for a Randomized Controlled Trial

The investigators investigated diastolic function among patients with obstructive sleep apnea (OSA) and hypertension stage I. In this randomized controlled trial, participants were randomly allocated to one of two groups: chlorthalidone associated with amiloride or amlodipine. Randomization was carried out prior to the start of the trial by an epidemiologist out of clinic and the randomization list was stratified by gender and severity of OSA. The research team and participants were blinded to the randomization list and allocation concealment was implemented. This trial aimed to detect changes in the echocardiography parameters with the drug treatment (higher in the intervention than in the placebo group). The investigators also assess change in daytime sleepiness among participants who already have been diagnosed with OSA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial, with participants randomly allocated to one of two groups: chlorthalidone associated with amiloride or amlodipine. Capsules were identical presentation and the research team and participants were blinded to the allocation list. The randomization list was stratified by gender and severity of OSA (AHI: 10-25 or 26-40) and in blocks in time, with size four and six units. Randomization was carried out prior to the start of the trial and it was generated by a validated software (Random Allocator). In order to ensure the confidentiality of the allocation list, it was generated by an epidemiologist who did not maintain direct contact with participants and the identification of the study drugs was done through alphanumeric code, implemented via software (RedCap).

Adherence to treatment was measured by counting returned capsules and through the Morisky questionnaire with eight questions, validated for Portuguese. Participants underwent initial clinical evaluation prior to randomization and after eight weeks of treatment for evaluation of outcomes. Demographic characteristics (age, gender, skin color), socioeconomic level (education), previous morbidity (diabetes mellitus, stroke, acute myocardial infarction, cancer, rheumatic diseases), treatments in use (anti-diabetic, anti-depressants, non-steroidal anti-inflammatory, corticosteroids, nasal vasoconstrictor, appetite suppressants, lipid-lowering drugs) and lifestyle characteristics (smoking and drinking) were collected in a standardized way. The investigators also assess anthropometric measures such as weight, height, waist, neck and hip circumference, and bioimpedance for determination of lean and fat mass. Blood pressure was measured using a validated digital oscillometric monitor, with cuff appropriate to the arm circumference, and two measurements per visit were made. In addition, ECG was performed and biochemical parameters (creatinine, blood glucose, serum potassium, uric acid, cholesterol and fractions, C-reactive protein and NT-proBNP) were determined in the laboratory of Hospital de Clinicas de Porto Alegre.

The transthoracic echocardiography is performed by the CX-50 unit (Philips, Bothell, WA - USA) with sectoral S5-1 transducer. Ambulatory monitoring of blood pressure will be measured through the Mortara AMBULO 2400 device (Mortara, Milwaukee, WI, USA) with measures 15/15 minutes during the day and 20/20 minutes at night, within 24 hours of a working day. Polysomnography will be held in type III (home with device that measures at least 4 cardiorespiratory variables) held with handset Sonmocheck (Weinmann GmbH, Hamburg, Germany), a monitor that detects the position of the patient, the presence of apneas or hypopneas, heart rate and digital oximetry.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40 to 70 years
  • Stage I hypertension (systolic BP: 140-159 or diastolic BP: 90-99 mmHg)
  • No antihypertensive treatment or use of one antihypertensive drug
  • Apnea / hypopnea index: 10 to 49 AH / hour

Exclusion Criteria:

  • Low life expectancy
  • Indication for use of calcium channel blockers or diuretics
  • Allergy medications study
  • Heart failure
  • Myocardial infarction
  • Recent stroke (last 3 months)
  • Secondary hypertension
  • Participation in another clinical trial (last 6 months)
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorthalidone plus amiloride

Chlorthalidone plus amiloride group received 25 mg of chlortalidone and amiloride, 5 mg.

A capsule with both drugs was taken once daily in the morning for eight weeks.
Drug: Chlorthalidone plus amiloride
A capsule with chlorthalidone plus amiloride was taken once daily in the morning for eight weeks.
Other Names:
  • Chlo+Ami
Active Comparator: Amlodipine
Amlodipine group received 10 mg. A capsule was taken once daily in the morning for eight weeks. Capsules of amlodipine had identical presentation of that the intervention drug.
Drug: Amlodipine
A capsule of amlodipine was taken once daily in the morning for eight weeks.
Other Names:
  • Amlo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E/A ratio
Time Frame: Change at eight weeks (end of the trial)
E/A (mitral inflow indices) echocardiography
Change at eight weeks (end of the trial)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daytime sleepiness
Time Frame: Change at eight weeks (end of the trial)
Increase in quality of life sleep-related (Functional Outcomes of Sleep Questionnaire; FOSQ-10) or reduction in daytime sleepiness (Epworth Sleepiness Scale)
Change at eight weeks (end of the trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Sandra C Fuchs, MD, PhD, Hospital de Clínicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2014

Primary Completion (Actual)

February 23, 2016

Study Completion (Actual)

February 14, 2017

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45007115.0.0000.5327
  • GPPG: 150274 (Other Identifier: Hospital de Clinicas de Porto Alegre)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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