To Determine the Effect of Nebivolol on Office Blood Pressure of Blacks Residing in Nigeria

NCT ID: NCT03598673

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2019-04-27

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.

Conditions

Hypertension

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Hypertensives to receiving Nevibolol

Patients to receive Nevibolol

The Efficacy and Tolerability of Nebivolol in Nigerians

Intervention Type: DRUG

To determine the effect of Nevibolol on office blood pressure of Blacks residing in Nigeria

Interventions

The Efficacy and Tolerability of Nebivolol in Nigerians

To determine the effect of Nevibolol on office blood pressure of Blacks residing in Nigeria

Intervention Type: DRUG

Other Intervention Names

Effect of Nebivolol in Nigeria

Eligibility Criteria

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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• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Micronova Pharmaceuticals Ind Ltd

UNKNOWN

Sponsor Role: collaborator

University of Abuja

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dike Ojji

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Africa International College

Abuja, Federal Capital Territory, Nigeria

University of Abuja Teaching Hospital

Abuja, Federal Capital Territory, Nigeria

Countries

Nigeria

References

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.

Reference Type: DERIVED

PMID: 33505995 (View on PubMed)

Other Identifiers

UAbuja

Identifier Type: -

Identifier Source: org_study_id