Study to evaluate whether adding dapagliflozin to existing blood pressure treatment improves blood pressure control in patients with uncontrolled hypertension

Effect of dapagliflozin 10 mg as add on therapy to existing antihypertensive medications on blood pressure and metabolic parameters in patients with uncontrolled hypertension attending a tertiary care hospital: An open label randomised interventional study - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104743

Enrollment

198

Registered

2026-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Dapagliflozin: Dapagliflozin 10 milligram orally once daily as add on therapy to existing antihypertensive medications for a duration of 12 weeks. Control Intervention1: Standard antihy

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed patients of hypertension with uncontrolled blood pressure of 140/90 mm of mercury or higher while receiving one or two antihypertensive drugs such as Telmisartan 40 mg once daily, Amlodipine 5 mg once daily, Enalapril 5 mg once daily, or their combination, with or without type 2 diabetes mellitus, will be considered for enrollment. Patients should be above 18 years of age and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Patients with secondary hypertension or accelerated hypertension. Patients with known hypersensitivity to sodium glucose co transporter 2 inhibitors. Patients already receiving sodium glucose co transporter 2 inhibitors. Pregnant or lactating women. Patients with active urinary tract infection or genital mycotic infection

Design outcomes

Primary

Measure	Time frame
Change in systolic blood pressure and diastolic blood pressure after addition of dapagliflozin 10 mg to existing antihypertensive therapy.Timepoint: baseline and 12 weeks	—

Secondary

Measure	Time frame
Change in fasting blood glucose, glycated haemoglobin, lipid profile, body weight, high sensitivity C reactive protein, blood urea nitrogen, serum creatinine, serum electrolytes, serum uric acid and urine routine and microscopy.Timepoint: Baseline and 12 weeks;Change in estimated glomerular filtration rate.Timepoint: Baseline and 12 weeks.;Change in echocardiographic parameters including left ventricular end diastolic dimension, left ventricular end systolic dimension, left ventricular ejection fraction and left atrial size.Timepoint: Baseline and 12 weeks.	—

Measure

Time frame

Change in fasting blood glucose, glycated haemoglobin, lipid profile, body weight, high sensitivity C reactive protein, blood urea nitrogen, serum creatinine, serum electrolytes, serum uric acid and urine routine and microscopy.Timepoint: Baseline and 12 weeks;Change in estimated glomerular filtration rate.Timepoint: Baseline and 12 weeks.;Change in echocardiographic parameters including left ventricular end diastolic dimension, left ventricular end systolic dimension, left ventricular ejection fraction and left atrial size.Timepoint: Baseline and 12 weeks.

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Countries

India

Contacts

Public ContactDr Richa Sharma

Indira Gandhi Medical College Shimla

pkkaundal66@gmail.com9816120050

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026