Clinical trial NCT04094714: CHACO Study: Control of Arterial Hypertension in Colombian Patients
Official title: CHACO Study: Control of Arterial Hypertension in Colombian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: Scandinavia Pharma
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colombian patients

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Patients with adequate control of the Blood Pressure (BP)
timeFrame: 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.
Secondary outcomes:
measure: Demographic analysis
timeFrame: 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.
measure: Treatment analysis
timeFrame: 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.
measure: Personal history of diseases
timeFrame: 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.
measure: Adverse Events related with the treatment
timeFrame: 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.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Scandinavia Pharma
Study officials:
affiliation: Scandinavia Pharma
name: Javier Castillo, Dr
role: STUDY_DIRECTOR
References: