Clinical trial NCT03598673: To Determine the Effect of Nebivolol on Office Blood Pressure of Blacks Residing in Nigeria
Official title: The Efficacy and Tolerability of Highly Selective Beta-1 Agent in Hypertensive Black Patients Residing in Sub Saharan Africa: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: University of Abuja
Sponsor class: OTHER
Collaborators: name: Micronova Pharmaceuticals Ind Ltd
First posted: 2018-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients should be aged 30-59 years with a sitting SBP ≥140 mm Hg and \<160 mmHg and/or DBP ≥ 90 and \<100 mmHg on no antihypertensive agent.

Brief summary: Although Nebivolol, a highly selective beta-1 agent has been shown to be effective in reducing blood pressure in Blacks, this was in African Americans with no study in Blacks residing in sub Saharan Africa. We therefore decided to study the effectiveness and safety of Nebivolol in Black patients with stage 1 hypertension (systolic BP of 140-149 and/or diastolic BP of 90-99 mmHg) presenting to five primary care centres in Nigeria.

Detailed description: Although Nebivolol, a highly selective beta-1 agent has been shown to be effective in reducing blood pressure in Blacks, this was in African Americans with no study in Blacks residing in sub Saharan Africa. It might be argued that findings in African-Americans can be extrapolated to Black Africans since they have the same ancestral origin, the differences in selection in previous generations, ethnic admixture and differences in lifestyle suggest that such an extrapolation may be inappropriate. We are therefore studying the effectiveness and safety of Nebivolol in Black patients with stage 1 hypertension (systolic BP of 140-149 and/or diastolic BP of 90-99 mmHg) presenting to primary care centres in Nigeria.

We hypothesise based on previous findings of the effect of Nebivolol on blood control of African Americans, we hypothesise that 5mg and 10mg of Nebivolol will be effective and well tolerated by black hypertensive patients residing in Nigeria.

The primary objective is to study the effect of 5mg and 10mg of Nebivolol on blood pressure control in Black African hypertensive patients residing in Nigeria. The secondary objectives are: to evaluate the rates of BP control (\<140 mmHg systolic and \<90 mmHg diastolic) achieved with 5mg and 10mg of Nebivolol respectively; to evaluate the incidence and the nature of adverse events with these two doses of Nebivolol; to evaluate the effects of these two doses of Nebivolol on fasting blood sugar and fasting lipid profile, and to evaluate the effect of these two doses on erectile dysfunction The primary outcome measure is change in office BP value from baseline to 2 months. This will be calculated as the difference between the mean office BP at randomization and that at the end of follow up. And the secondary endpoints are: to determine the proportion of patients who achieve BP \<140 mmHg systolic and \<90 mmHg diastolic in two months; to determine the proportion of patients who have adverse events with both doses of Nebivolol respectively; to study the change in plasma fasting blood sugar and fasting lipid profile over two months, and to see proportion of male patients who complain of erectile dysfunction on follow up and end of the study.

It is is a prospective, observational program among hypertensive patients with 3 months follow up.

Eligibility criteria: Inclusion Criteria: The patients should be aged 30-59 years with a sitting SBP ≥140 mm Hg and \<160 mmHg and/or DBP ≥ 90 and \<100 mmHg on no antihypertensive agent

Exclusion Criteria:

1.Those with clinically defined congestive heart failure 2. Those with clinical features of renal failure 3. Those with history of coronary heart disease including chronic stable angina, myocardial infarction or acute coronary syndrome 4. Patients with a history of a stroke or transient ischaemic attack 5. Patients with known or suspected secondary hypertension 6. Those with any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study 7. Those who are pregnant or those of child-bearing age who are not taking reliable contraception.

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Primary outcomes:
measure: Change in office blood pressure
timeFrame: 2 months
Secondary outcomes:
measure: The proportion of patients who achieved blood control
timeFrame: 2 months
measure: Proportion of patients with adverse events
timeFrame: 1 month and 2 months
measure: Change in metabolic profile
timeFrame: 2 months
measure: Proportion of male patients with erectile dysfunction
timeFrame: 1 month and 2 months
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: Africa International College
state: FCT
city: Abuja
country: Nigeria
facility: University of Abuja Teaching Hospital
state: Federal Capital Territory
Study officials:
References:
citation: Ojji D, Ale BM, Shedul L, Umuerri E, Ejim E, Alikor C, Agunyenwa C, Njideofor U, Eze H, Ansa V. The Effect of Nebivolol on Office Blood Pressure of Blacks Residing in Sub-Saharan Africa (A Pilot Study). Front Cardiovasc Med. 2021 Jan 11;7:613917. doi: 10.3389/fcvm.2020.613917. eCollection 2020.