Metabolic Syndrome Clinical Trial
— COMPOSEROfficial title:
Open-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
The aim of study is to assess the angioprotective effects of antihypertensive combination
therapy with perindopril 10 mg and moxonidine 0.4-0.6 mg in patients with arterial
hypertension, metabolic syndrome, and obesity, who had Pulse Wave Velocity (PWV) > 10 m/s on
the previously administered two-component combination antihypertensive therapy.
Open-label non-comparative prospective study for 24 week for each patient.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Dept. of Therapy and Endocrinology | Volgograd |
Lead Sponsor | Collaborator |
---|---|
Sergey V. Nedogoda |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pulse wave velocity (PWV) | To assess the PWV after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level. | baseline and 24 weeks | |
Primary | Change in Central Blood Pressure (BP) | To assess the central BP changes (systolic BP, aortic pulse BP) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels. | baseline and 24 weeks | |
Primary | Change in Reflected wave index | To assess the reflected wave index after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level. | baseline and 24 weeks | |
Secondary | Change in carbohydrate and lipid metabolism parameters markers | To assess the homeostatic model assessment - insulin resistance (HOMA-IR), and lipid metabolism (total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL)) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels. | baseline and 24 weeks | |
Secondary | Change in the adipokine level | To assess the adipokine level (leptin) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level. | baseline and 24 weeks | |
Secondary | Change in the Inflammatory marker level | To assess the high sensible C-reactive Protein (hs-CRP) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level. | baseline and 24 weeks | |
Secondary | Change in the renin-angiotensin-aldosterone system hyperactivation marker level | To assess the renin-angiotensin-aldosterone system hyperactivation marker level (plasma aldosterone-to-renin ratio) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level | baseline and 24 weeks | |
Secondary | Change in the sympathoadrenal system hyperactivation marker levels | To assess the sympathoadrenal system hyperactivation marker levels (urine excretion adrenaline, noradrenaline, dofamine levels) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels. | baseline and 24 weeks | |
Secondary | Proportion of patients achieved target BP level | To assess the proportion of patients (%) achieving target BP levels <130/80 mm Hg at Week 4, Week 12, Week 24 | Week 4, Week 12, Week 24 |
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