Comparative Effects of Perindopril and Zofenopril on Blood Pressure Control and Oxidative Status Blacks Hypertensive Patients.

Study Overview
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Brief Summary
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The aim of the study is to compare the short term effect of perindopril and zofenopril in the management of hypertension and the oxydative stress in blacks hypertensive patients. PEZO-HP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital.

Detailed Description
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Aim: to determine and compare the short term effect of angiotensin converting in the management of hypertension as well as the oxidative effect of Zofenopril and perindopril in blacks hypertensive patients in the Yaoundé Central Hospital. Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital. Hypertensive patients who are not taking angiotensin-converting enzyme inhibitor or angiotensin receptors blockers, are randomize into 2 groups. Depending on the group, the intervention consisted of the administration of Perindopril 10 mg daily or Zofenopril 30 mg daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant). Progress: Recruitment for PEZO-HP was completed in May 2019 with 24 patients.

Official Title
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Rationale and Design of a Simple Randomized Trial Evaluating Comparative Effects of Perindopril and Zofenopril in Blacks Hypertensive Patients: Short Term Effects on Cardiac and Oxidative Status With Perindopril or Zofenopril (PEZO-HP) Trial

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Perindopril Arginine
* Drug: Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertensive patients On a stable atihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker Subject must not present any contraindication to exercise Before any study-specific procedure, the appropriate written informed consent must be obtained. Exclusion Criteria: Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board). Withdrawal of consent

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perindopril Arm<br>10 mg Perindopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks. | Drug: Perindopril Arginine<br>* 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.<br>* Other names: Perindopril;|
| Active Comparator: Zofenopril Arm<br>30 mg Zofenopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks. | Drug: Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer<br>* 30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.<br>* Other names: Zofenopril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nycthemeral blood pressure profile (mmHg) | Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum concentration of oxidant marker: malondialdehyde (micromol/l) | Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer | 8 weeks | 
| Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol) | Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiotensin Converting Enzymes Inhibitor, Angiotensin II Receptor Blockers, Blood pressure, Oxidative status