Clinical trial NCT03539627: Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus.
Official title: One-center, Observational, Non-interventional, Prospective Study of the Efficacy of Azilsartan Medoxomil in Patients With Arterial Hypertension Associated With Stable Ischemic Heart Disease and Type 2 Diabetes Mellitus.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Diabetes Mellitus
Stable Chronic Angina
Keywords: diabetes mellitus
Edarbi
hypertension
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus

Brief summary: One-center, observational, non-interventional, prospective study of the efficacy of azilsartan medoxomil in patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus.

Detailed description: One-center, observational, non-interventional, prospective study of the efficacy of azilsartan medoxomil in patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus.

During the study 5 visits to the research center are planned. At each visit, a physical examination, sampling of bio-samples for evaluation in the local laboratory, and collection of information on adverse events will be performed. 24-hours monitoring of blood pressure will be performed at screening, after 1 months of therapy and at the final visit (6 months of therapy).

Data will be collected during 5 consecutive visits to the research center. The observation period will be about 6 months, the active treatment period will be at least 6 months (24 weeks). Patients included in the study will be observed in an outpatient clinic according to the local practice of the research center.

It is planned that potentially eligible patients will be invited to the screening visit. Based on the results of daily monitoring of blood pressure, a final decision will be made about the suitability of the patient to participate in the study. Patients who have not reached the target values of blood pressure will start taking the study drug (Edarbi). By not achieving the target values of blood pressure, the mean daily systolic blood pressure is more than 130 mm Hg and the diastolic blood pressure is more than 90 mm Hg. The length of time between Visit 1 and Visit 2 is suspected to be no longer than 2 weeks.

All examinations (examination and evaluation of vital functions, laboratory tests, instrumental examinations) will be performed in accordance with the general standards of medical practice and in accordance with the routine practice of the institution.

Based on the number of patients hospitalized in the Research Institute For Complex Issues Of Cardiovascular Diseases (1500 patients), as well as the data on the prevalence of type 2 diabetes in this group (23.5%, 353 patients), the required sample size will be 184 patients (Confidence interval ± 5 %, the confidence probability is 95%).

SS = Z2 \* (p) \* (1-p) C2 where: Z = Z factor (1,96 for 95% confidence interval) p = percentage of respondents required, in decimal form (0,5 by default) c = confidence interval, in decimal form (for example, 0,04 = ±4%).

Eligibility criteria: Inclusion Criteria:

1. Informed consent signed by the patient.
2. Men and women aged 18 years and older with a previously diagnosed hypertension and type 2 diabetes mellitus and stable ischemic heart disease.
3. Stable therapy of hypertension, T2DM and ischemic heart disease for at least 12 weeks before screening.
4. Not achievement of target values \* of blood pressure against the background of previously prescribed and steadily accepted antihypertensive therapy.

   \* not reaching the target figures of arterial pressure means mean systolic blood pressure more than 130 mm Hg and / or an average diastolic blood pressure more than 90 mmHg.
5. Investigator's decision on the advisability of correction of previously prescribed therapy with the replacement of ACE inhibitors or other ARBs with azilsartan medoxomil.

Exclusion Criteria:

1. Contraindications to the azilsartan medoxomil in accordance with instruction for use, including information on the individual intolerance of the drug.
2. Any circumstances in the opinion of the investigator that interfere with the participation of the patient in the study.
3. The patient included in the study is an employee of the center or a relative of the investigator.
4. Participation in other clinical trials. Participation in register studies is allowed.
5. Any disease or condition that leads to a decrease in the patient's life expectancy.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: interval: up to 24 weeks
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: interval: up to 24 weeks
measure: Dynamics of renal function (filtration)
timeFrame: interval: up to 24 weeks
measure: Edarbi® efficacy
timeFrame: interval: up to 24 weeks
measure: Dynamics of renal function (evidence of kidney injury)
timeFrame: interval: up to 24 weeks
measure: Dynamics of renal function (proteinuria detecton)
timeFrame: interval: up to 24 weeks
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Anastasia Kochergina
Study officials:
References: