Occurrence of Dyskalemia With Treatment for Hypertension

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Hypertension is a major public health issue associated with significant morbidities and mortality. Fixed dose combination (FDC) pills, combining 2 or more classes of antihypertensive medications have considerable appeal because they may reduce blood pressure more effectively and efficiently compared to monotherapy. However, because FDC medication causes 'dyskalemia', the occurrence of either hypo- or hyper-kalemia, which requires laboratory testing, implementing FDC is hampered in some low- and middle-income countries where laboratory testing is limited. This study will be conducted in the area of Mirpur in Dhaka, Bangladesh, to 1) estimate the prevalence of dyskalemia in hypertensive patients who are candidates for pharmacotherapy; and 2) of those patients initiating a FDC combining telmisartan 40 mg/amlodipine 5 mg, estimate the incidence of dyskalemia at two months later. Telmisartan is a widely prescribed drug approved by Directorate General of Drug Administration (DGDA). If the prevalence and incidence of dyskalemia is low, as anticipated, our results will provide evidence that routine laboratory testing might not be necessary. It is to be mentioned that Telmisartan is not a new drug and it is a widely prescribed drug approved by Directorate General of Drug Administration (DGDA), Bangladesh

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Heart Foundation of Bangladesh
• Collaborators: Johns Hopkins University; National Heart Foundation Hospital and Research Institute of Bangladesh; Resolve to Save Lives, USA.
• Treatments: Amlodipine; Telmisartan

Criteria

Inclusion Criteria:

• Age ≥40 years for men and ≥ 50 years for women who had menopause for 1 year

• Systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg (average across two visits as detailed in 'Measurements' section below)

• Adults not currently (in the past month) taking BP medications

Exclusion Criteria:

• SBP of ≥180 mmHg, DBP of ≥120 mmHg

• Creatinine clearance (Cockcroft-Gault Equation) <30 ml/min

• Serum potassium >5 or <3 mmol/L

• History of intolerance or allergy to ACEI, ARB, or calcium channel blockers

• Women who are currently pregnant, or planning to become pregnant

• Women who are currently breastfeeding

• Other serious conditions (e.g., those with heart failure treated with medication, COPD patients using Salbutamol etc)