Clinical trial NCT04254042: Comparative Effects of Perindopril and Zofenopril on Blood Pressure Control and Oxidative Status Blacks Hypertensive Patients.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Angiotensin Converting Enzymes Inhibitor
Angiotensin II Receptor Blockers
Blood pressure
Oxidative status
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in nycthemeral blood pressure profile (mmHg)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)
timeFrame: 8 weeks
measure: Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital, Cardiology department
Study officials:
References: