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Blood pressure reduction in patients with high blood pressure (hypertension) with diet and lifestyle modification

Efficacy and safety of Twin Precision treatment in patients with hypertension - a multicentre, open-label, randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17705472
Enrollment
300
Registered
2022-04-25
Start date
2022-05-01
Completion date
Unknown
Last updated
2022-05-09

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

Conditions

Hypertension Circulatory System

Interventions

Patients randomized to the intervention group will follow the medicine, exercise, sleep and nutritional syntax of the Twin Precision Treatment program. Group 1 Standard care arm

Sponsors

Twin Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of primary hypertension (either adequately controlled or inadequately controlled with blood pressure =180/110 mm Hg); both treatment-naive & on treatment (includes monotherapy or multiple drugs) 2. Aged 18 years and above 3. Willing to follow study specific activities and able to handle smartphone

Exclusion criteria

Exclusion criteria: 1. Uncontrolled hypertension (>180/110 mm of Hg) or history of hypertensive emergency requiring admission 2. Hypertension due to secondary causes 3. History of Diabetes mellitus (when either of the following criteria is met: on medications to control blood sugar or FBS >126 mg/dl; RBS >200 mg/dl; HbA1c =6.5) 4. Symptomatic heart failure or EF 10.5 mg/dl) and Hyperkalemia.(>5.5 mmol/l) 13. Known Malignant cases 2 mg/dL or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 5 times the upper limit of normal range 21. Pregnant or planning to conceive in the next 3 years or breastfeeding 22. Psychiatric illness such as psychosis, manic depressive illness, alcohol or drug dependence. 23. Consumption of >14 alcoholic beverages per week (for women) and >21 for men 24. Any other condition or illness that the investigator feels would make the patient ineligible or make the patient difficult to participate in the study

Design outcomes

Primary

MeasureTime frame
1. Blood pressure as measured by ambulatory blood pressure monitoring at baseline and the end of 1 year 2. Blood pressure as measured in the clinic at baseline and the end of 1 year

Secondary

MeasureTime frame
1. Blood pressure (clinical and ambulatory blood pressure) at baseline, 6 months, and 2 years 2. Adequate control of blood pressure as measured by ambulatory blood pressure monitoring at 1 year and 2 years Criteria for adequate control of blood pressure is: In <65 years < 130/80 mm Hg In 65 and above < 140/90 mm Hg 3. Number of antihypertensive medications at 6 months, 1 year and 2 years measured using patient records

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026