Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients

Hypertension Clinical Trial

Official title:

Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients Subjected to Distinct Interventions: Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211248
• Other study ID #: 4524/10
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: August 6, 2014
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2014
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Above 18 years of age

• Diagnosis of primary hypertension

Exclusion Criteria:

• Neurological condition

• Cardiac condition

• Renal condition

• Congenital conditions

• Previous myocardial revascularization surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Multidisciplinary assistance
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).
• Conventional treatment and follow up
Assistance was effected by physician and nurse and consisted about adapting to the drug

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Cardiac Frequency Variability at 1 year		Measured at the first appointment and 1 year later	Yes
Secondary	Change from Baseline in Systolic and Diastolic Blood pressure		Measured at the first appointment and 1 year later	Yes