Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus. (AcADEME)

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.

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Arterial Hypertension; Stable Chronic Angina
• Intervention / Treatment: Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]

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%).

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Anastasia Kochergina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with hypertension, CAD and diabetes; Patients with hypertension associated with stable CAD and diabetes on azilsartan medoxomil (Edarbi) therapy	Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]; patients are to receive azilsartan medoxomil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®	interval: up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic blood pressure	Dynamics of clinical DBP from the baseline against the background of therapy with Edarbi® (interval: Visit of inclusion - Visit 5);	interval: up to 24 weeks
Dynamics of renal function (filtration)	Dynamics of eGFR	interval: up to 24 weeks
Edarbi® efficacy	proportion of patients who respond to Edarbi® therapy (defined as decrease of SBP≥ 20 mm Hg or decrease of DBP≥10 mm Hg)	interval: up to 24 weeks
Dynamics of renal function (evidence of kidney injury)	N-GAL-dynamics	interval: up to 24 weeks
Dynamics of renal function (proteinuria detecton)	UACR dynamics	interval: up to 24 weeks

Collaborators and Investigators

• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Publications and helpful links

Helpful Links

• Kochergina A.M., Barbarash O.L. Azilsartan medoxomil: opportunities and prospects in diabetes mellitus. "Arterial'naya Gipertenziya" ("Arterial Hypertension"). 2021;27(2):247-254. (In Russ.)

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: hypertension; diabetes mellitus; Edarbi
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Coronary Disease; Chest Pain; Angina Pectoris; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Hypertension; Diabetes Mellitus; Angina, Stable; Molecular Mechanisms of Pharmacological Action; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Azilsartan medoxomil
• Other Study ID Numbers: IISR-2017-102380

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No