Status:
UNKNOWN
Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
Lead Sponsor:
Sergey V. Nedogoda
Conditions:
Arterial Hypertension
Metabolic Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 syn...
Detailed Description
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 dos...
Eligibility Criteria
Inclusion
- Patients (male and female) aging 18 to 70 years.
- Grade 1, 2 AH (SBP 140-179 mm Hg and/or DBP 90-109 mm Hg according 2018 ESH/ESC guidelines)
- PWV \> 10 m/s
- 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
- Metabolic syndrome diagnosed by the 2009 Russian Society of Cardiology (RSC) National Guidelines criteria
- THE MAIN SIGN: central (abdominal) obesity defined as waist circumference (WC) above 80 cm in women and above 94 cm in men.
- 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.
- Body Mass Index (BMI) \>30 kg/m2.
- For female patients with childbearing potential: negative pregnancy test and willingness to use reliable methods of contraception until the study treatment completion
- Voluntarily signed informed consent to participate in the study.
Exclusion
- Contraindications for using ACEi and imidazoline receptor agonists.
- Administration of perindopril or moxonidine during 6 months before the study onset.
- 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).
- 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).
- Current diagnosis of unstable angina, acute and subacute myocardial infarction.
- Heart failure of any functional class.
- Grade 3 AH (≥ 180/110 mm Hg).
- Sinus bradycardia (heart rate ≤50/min).
- Type 1 or 2 diabetes mellitus.
- Severe comorbidities, including mental diseases.
- Acute conditions (infections, exacerbation of chronic diseases, injuries, surgical interventions).
- Alcohol abuse.
- Pregnancy and lactation.
- Serious renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≤30 ml/min/1.73 m2).
- Serious hepatic dysfunction
- Malignancies diagnosed and treated during the previous 5 years prior to study enrollment.
- Inability to understand the study and to give informed consent for participation in it.
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04023565
Start Date
March 11 2019
End Date
December 30 2020
Last Update
July 23 2019
Active Locations (1)
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1
Dept. of Therapy and Endocrinology
Volgograd, Russia, 400131