deliVERy of Optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria

Not Applicable

Recruiting

• Conditions: Cardiology

• Registration Number: PACTR202107579572114
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

At screening visit
1.Black African
2.Adult (age =18 years)
3.Provided signed consent to participate in the study
4.Untreated or on one BP-lowering medication for =2 weeks
5.Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based
on BP at this and/or previous visits
6.Willingness to use home BP measurement device and measure BP at home for 6 months
At randomisation visit
1.Untreated or on one BP-lowering medication for =2 weeks
2.Clinic attended automated seated mean SBP (average of last 2 measurements): 140-179 mmHg and/or DBP 90-
109 mmHg
3. Willingness to use home BP measurement device and measure BP at home for 6 months
4. Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based
on BP at this and/or previous visits

Exclusion Criteria

At Screening and randomisation visit
1.Receiving 2 or more BP-lowering medications. (a single pill combination containing two different BP-lowering medications should be considered as 2 BP-lowering medications)
2.Receiving any BP lowering medications for indications other than hypertension (e.g., heart failure)
3.Current/history of congestive heart failure
4.Current/history of coronary heart disease including angina, myocardial infarction, or acute coronary syndrome
5.Current/history of atrial fibrillation
6.Current/history of a stroke or transient ischemic attack
7.Known or suspected secondary hypertension
8.Hyper-/hypothyroidism, pheochromocytoma, or arteriovenous fistula
9.Current/history of Raynaud’s disease
10.Uncontrolled diabetes mellitus (glycosylated haemoglobin >11% [> 97 mmol/mol]) within last three months
11.Current/history of end-stage renal disease or anuria or current estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2)
12.Pregnancy, or had a positive pregnancy test, or unwilling to undertake a pregnancy test before randomisation, and/or during the study, and up to 14 days after the discontinuation of the study medication, or breastfeeding, or of childbearing age and not using highly effective method of contraception
13.Not suitable for participation in a clinical study according to local ethical or regulatory requirements related to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
14.Contraindication, including hypersensitivity (e.g., anaphylaxis or angioedema) to any of the study medications or procedures
15.Participation in any investigational medication and/or device study within the 30 days prior to randomisation
16.Current concomitant illness or physical impairment or mental condition or abnormal laboratory value, which in the judgment of the investigator could interfere with the effective conduct of the study or constitutes a significant risk to the participants’ safety or well-being

Study & Design

• Study Type: Interventional
• Study Design: Not specified