Cardiology
Conditions
Interventions
Triple pill based treatment protocol
Nigeria hypertension treatment protocol
Sponsors
The George Institute for Global Health
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in change in home seated mean SBP from randomisation to month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with clinic seated mean SBP <140 mmHg and DBP <90 mmHg at month 6;Difference in change in home seated mean SBP from randomisation to month 1, 2, and 3;Mean time to first week of home seated mean SBP <130 and DBP <80 mmHg;Mean time at home seated mean SBP <130 and DBP <80 mmHg from randomisation to month 6;Difference in change in home seated mean DBP from randomisation to month 1, 2, 3, and 6;Percentage of participants with clinic seated mean SBP <140 mmHg and DBP <90 mmHg at month 1, 2 and 3;Percentage of participants with home seated mean SBP <130 mmHg and DBP <80 mmHg at month 1, 2, 3, and 6;Difference in change in clinic seated mean SBP and DBP from randomisation to month 1, 2, 3, and 6 | — |
Countries
Nigeria
Contacts
Public ContactDike Ojji
Consultant Caridiologist University of Abuja Teaching Hospital
Outcome results
None listed