Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sergey V. Nedogoda
• Treatments: Moxonidine; Perindopril

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.