CHACO Study: Control of Arterial Hypertension in Colombian Patients

• Conditions: Hypertension

• Registration Number: NCT04094714
• Lead Sponsor: Scandinavia Pharma

Brief Summary

Epidemiological study (cross-sectional study) in order to determine the patients who present an adequate control of the Blood Pressure (BP), in a population of Colombian patients diagnosed with Arterial Hypertension (AH) and who are under pharmacological treatment.

Detailed Description

OBJECTIVE: To determine the proportion of patients who present an adequate control of the Blood Pressure (BP), in a population of Colombian patients diagnosed with Arterial Hypertension (AH) and who are under pharmacological treatment.

MATERIALS AND METHODS: Epidemiological study (cross-sectional study), multicentre type, in patients older than 18 years with prior diagnosis of AH in Colombia. The blood pressure control will be evaluated as the main variable (only one single blood pressure check in the doctor's office). Other secondary variables to evaluate are: demographical analysis, type (s) of antihypertensive treatment (s) used in patients, level of BP control, adverse events associated with antihypertensive treatment, comorbidities and risk factors, adherence, perception about the possible benefits of the use of combined therapy in "mono-tablet" versus "multi-tablet". The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.

Study Timeline

• Study Start: 2019-06-27
• Status Verified: 2019-09
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-19
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23
• Primary Completion: 2023-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Age ≥ 18 years
• Prior diagnosis of Arterial Hypertension (AH) ≥ 3 months before
• Patients who are under pharmacological treatment of AH ≥ 3 months before

Exclusion Criteria

• The patient has rejected the participation in the study.
• Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer the questions.
• Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients with adequate control of the Blood Pressure (BP)	It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.	Proportion of patients who present an adequate control of the Blood Pressure (BP)

Secondary Outcome Measures

Name	Time	Method
Adverse Events related with the treatment	It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.	Adverse events associated with the treatment (s)
Personal history of diseases	It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.	Evaluation of personal history of diseases
Treatment analysis	It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.	Characterization of treatment (s) used
Demographic analysis	It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.	Characterization of patients

Trial Locations

Locations (1)

Scandinavia Pharma; 🇨🇴 Bogotá, Colombia