NCT02896621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Dec 2014

Typical duration for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2017

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

July 15, 2016

Last Update Submit

June 13, 2018

Conditions

HypertensionSleep Apnea

Keywords

Sleep ApneaHypertensionChlortalidoneDiastolic function

Outcome Measures

Primary Outcomes (1)

  • E/A ratio

    E/A (mitral inflow indices) echocardiography

    Change at eight weeks (end of the trial)

Secondary Outcomes (1)

  • Daytime sleepiness

    Change at eight weeks (end of the trial)

Study Arms (2)

Chlorthalidone plus amiloride

EXPERIMENTAL

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

Amlodipine

ACTIVE COMPARATOR

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

Interventions

Chlorthalidone plus amilorideDRUG

A capsule with chlorthalidone plus amiloride was taken once daily in the morning for eight weeks.

Also known as: Chlo+Ami
Chlorthalidone plus amiloride
AmlodipineDRUG

A capsule of amlodipine was taken once daily in the morning for eight weeks.

Also known as: Amlo
Amlodipine

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

HypertensionSleep Apnea Syndromes

Interventions

ChlorthalidoneAmilorideAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrazinesHeterocyclic Compounds, 1-RingDihydropyridinesPyridines

Study Officials

  • Sandra C Fuchs, MD, PhD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

September 12, 2016

Study Start

December 7, 2014

Primary Completion

February 23, 2016

Study Completion

February 14, 2017

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations

BR(1)