Hypertension
Conditions
Keywords
Angiotensin Converting Enzymes Inhibitor, Angiotensin II Receptor Blockers, Blood pressure, Oxidative status
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.
Interventions
10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
DRUGZofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer
30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
Sponsors
Yaounde Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Perindopril and Zofenopril were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.
Intervention model description
PEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nycthemeral blood pressure profile (mmHg) | 8 weeks | Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum concentration of oxidant marker: malondialdehyde (micromol/l) | 8 weeks | Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer |
| Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol) | 8 weeks | Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer |
Countries
Cameroon
Outcome results
None listed