COMPOSEROpen-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
perindopril + moxonidine
Cardiovascular Diseases+6
+ Hyperinsulinism
+ Hypertension
Treatment Study
Summary
Study start date: March 11, 2019
Actual date on which the first participant was enrolled.According to European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) Guidelines for the management of arterial hypertension 2018 in case of previous combination at full dose does not allow to achieve the target Blood Pressure (BP), that therapy might be switch to different two-drug combination. The study will enroll 120 hypertensive (Grade 1, 2 Arterial Hypertension (AH): Systolic Blood Pressure (SBP) 140-179 mm Hg and Diastolic Blood Pressure (DBP) 90-109 mm Hg According to ESC/ESH Guidelines 2018) patients with metabolic syndrome who met the inclusion criteria when treated with Angiotensin Converting Enzyme Inhibition(ACEi) /Angiotensin Receptor Blocker (ARB) + hydrochlorothiazide (HCTZ)/indapamide or +amlodipine (30 patients in each group): 1. ACEi (except perindopril) + diuretic (HCTZ or indapamide) 2. ACEi (except perindopril) + amlodipine 3. ARB+ diuretic (HCTZ or indapamide) 4. ARB+ amlodipine Upon obtaining Inform Consent the previous therapy will be discontinued according to recommendations (gradually or at once). After 14 days of wash-out period perindopril 10 mg + moxonidine 0.4 mg a day will be prescribed. If target BP is not achieved after 4 weeks, the dosage will increase up to perindopril 10 mg + moxonidine 0.6 mg a day (given as two divided doses). FORBIDDEN TREATMENTS: Any other antihypertensives (calcium antagonists, β-blockers, ACEi except perindopril, ARBs, diuretics) for routine AH management (except those used to resolve the uncontrolled hypertension). CRITERIA FOR PREMATURE PATIENT WITHDRAWAL FROM THE STUDY: 1. Withdrawal of informed consent by the patient at any time of the study. 2. Need for uncontrolled hypertension management occurring more than 2 times weekly throughout the 2 consecutive weeks during study period. 3. Need for the third antihypertensive drug.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patients (male and female) aging 18 to 70 years. 2. Grade 1, 2 AH (SBP 140-179 mm Hg and/or DBP 90-109 mm Hg according 2018 ESH/ESC guidelines) 3. PWV \> 10 m/s 4. Previous two-component antihypertensive therapy (ACEi/ARB+ diuretic (HCTZ or indapamide) or ACEI/ARB + amlodipine) during at least 6 months prior to the study enrollment 5. Metabolic syndrome diagnosed by the 2009 Russian Society of Cardiology (RSC) National Guidelines criteria 1. THE MAIN SIGN: central (abdominal) obesity defined as waist circumference (WC) above 80 cm in women and above 94 cm in men. 2. ADDITIONAL CRITERIA: i. - arterial hypertension (BP ≥ 130/85 mm Hg) ii. - high triglycerides (≥ 1.7 mmol/l) iii. - decreased HDL-cholesterol (\<1.0 mmol/l for men; \<1.2 mmol/l for women) iv. - increased LDL-cholesterol \> 3.0 mmol/l v. - fasting hyperglycaemia (fasting plasma glucose ≥ 6.1 mmol/l) vi. - impaired glucose tolerance (plasma glucose at 2 hours after glucose load from ≥7.8 to ≤11.1 mmol/l) Metabolic syndrome is defined as presence of central obesity and two of the additional criteria. 6. Body Mass Index (BMI) \>30 kg/m2. 7. For female patients with childbearing potential: negative pregnancy test and willingness to use reliable methods of contraception until the study treatment completion 8. Voluntarily signed informed consent to participate in the study. Exclusion Criteria: 1. Contraindications for using ACEi and imidazoline receptor agonists. 2. Administration of perindopril or moxonidine during 6 months before the study onset. 3. Metformin therapy for prophylaxis diabetes mellitus type 2 in patients with pre-diabetes, which had been started within 6 months before the study enrollment. (If a patient receives metformin for a long time, i.e., more than 6 months, he/she can be included in the study, and metformin discontinuation is not required). 4. Statin and/or fibrate therapy started within 6 months before the study enrollment. (If a patient receives statins and/or fibrates for a long time, i.e., more than 6 months, he/she can be included in the study, and discontinuation of statins and fibrates is not required). 5. Current diagnosis of unstable angina, acute and subacute myocardial infarction. 6. Heart failure of any functional class. 7. Grade 3 AH (≥ 180/110 mm Hg). 8. Sinus bradycardia (heart rate ≤50/min). 9. Type 1 or 2 diabetes mellitus. 10. Severe comorbidities, including mental diseases. 11. Acute conditions (infections, exacerbation of chronic diseases, injuries, surgical interventions). 12. Alcohol abuse. 13. Pregnancy and lactation. 14. Serious renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≤30 ml/min/1.73 m2). 15. Serious hepatic dysfunction 16. Malignancies diagnosed and treated during the previous 5 years prior to study enrollment. 17. Inability to understand the study and to give informed consent for participation in it.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Dept. of Therapy and Endocrinology
Volgograd, RussiaOpen Dept. of Therapy and Endocrinology in Google Maps