Occurrence of Dyskalemia With Treatment for Hypertension
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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
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.