Occurrence of Dyskalemia With Treatment for Hypertension

NCT05155436 | Completed Phase 4 DMC

• 1 other identifier: 20210921/4
• Study Type: interventional
• Target: 1,090
• Locations: 1 country
• Sites: 1

Brief 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 these drugs 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 the Directorate General of Drug Administration (DGDA). If the prevalence and incidence of dyskalemia is low, as anticipated, this study 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 the Directorate General of Drug Administration (DGDA), Bangladesh

Conditions

Hypertension; Potassium Imbalance

Keywords

Hyperkalemia; Hypertension; Hypokalemia

Outcome Measures

Primary Outcomes (2)

• Prevalent dyskalemia at baseline in patients eligible for antihypertensive medications.

  to find out the prevalence of dyskalemia at baseline in patients eligible for antihypertensive medications.

  2 months from administration of intervention

• Incident dyskalemia after 2 months of therapy (dyskalemia defined as a follow-up serum potassium < 3.0 or > 5.5 mmol/L

  to estimate the number of patients with dyskalemia after administration of FDC for 2 months.

  2 months from administration of intervention

Secondary Outcomes (4)

• Hyperkalemia alone

  2 months from administration of intervention

• Hypokalemia alone

  2 months from administration of intervention

• Blood pressure change

  2 months from administration of intervention

• Adherence

  2 months from administration of intervention

Study Arms (1)

Fixed-Dose Combination pill of Telmisartan and Amlodipine

EXPERIMENTAL

Fixed-Dose Combination pill of Telmisartan 40 mg and Amlodipine 5 mg, once daily for 3 months

Drug: Fixed Dose Combination pill of Telmisartan 40mg and Amlodipine 5 mg

Interventions

Fixed Dose Combination pill of Telmisartan 40mg and Amlodipine 5 mg DRUG

Participants without prevalent hyperkalemia will receive the fixed-dose combination pill of Telmisartan and Amlodipine, once daily for 3 months.

Fixed-Dose Combination pill of Telmisartan and Amlodipine

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Heart Foundation of Bangladesh: lead
• National Heart Foundation Hospital and Research Institute of Bangladesh: collaborator
• Johns Hopkins University: collaborator
• Resolve to Save Lives: collaborator

Study Sites (1)

National Heart Foundation of Bangladesh

Dhaka, 1216, Bangladesh

Location

Related Publications (17)

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  PMID: 1534713 BACKGROUND

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MeSH Terms

Conditions

Hypertension; Hyperkalemia; Hypokalemia

Interventions

Telmisartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Fazilatunnesa Malik, MBBS, FCPS

  National Heart Foundation, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The people residing in Mirpur at Dhaka city have been included in this study with matching the inclusion criteria which are as follows: 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

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: January 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)