NCT02211248

Brief Summary

Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional treatment of hypertensive patients will provide better parameters for comparing the two approaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Dec 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

1.6 years

First QC Date

July 31, 2014

Last Update Submit

August 6, 2014

Conditions

Hypertension

Keywords

Cardiac Frequency Variabilitymultidisciplinary careclinical trial

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Cardiac Frequency Variability at 1 year

    Measured at the first appointment and 1 year later

Secondary Outcomes (1)

  • Change from Baseline in Systolic and Diastolic Blood pressure

    Measured at the first appointment and 1 year later

Study Arms (2)

Conventional Group

ACTIVE COMPARATOR

Conventional treatment and follow up

Other: Conventional treatment and follow up

Multidisciplinary Group

EXPERIMENTAL

Multidisciplinary assistance

Other: Multidisciplinary assistance

Interventions

Multidisciplinary assistanceOTHER

Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).

Multidisciplinary Group
Conventional treatment and follow upOTHER

Assistance was effected by physician and nurse and consisted about adapting to the drug

Conventional Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years of age
  • Diagnosis of primary hypertension

You may not qualify if:

  • Neurological condition
  • Cardiac condition
  • Renal condition
  • Congenital conditions
  • Previous myocardial revascularization surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 7, 2014

Study Start

December 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

BR(1)