High blood pressure Circulatory System Hypertension
Conditions
Interventions
Twin Precision treatment involves providing a personalising diet based on glycaemic excursions along with care of macro and micronutrients.
The first phase will be a pilot study to ch
Sponsors
Twin Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients between 18 to 70 years of age 2. On treatment for hypertension (monotherapy or multiple drugs)
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension (>180/110 mm/Hg) or history of hypertensive emergency requiring admission 2. Hypertension due to secondary causes 3. Diabetes mellitus 4. Heart failure with EF <45% 5. eGFR less than 60 ml/min/1.73 m² 6. Any major cardiovascular event in the last 12 months (such as MI, stroke, TIA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood pressure as measured by ambulatory blood pressure monitoring at baseline and 3 months 2. Blood pressure as measured in the clinic (sphygmomanometer) at baseline and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood pressure measured by ambulatory blood pressure monitoring and in the clinic (sphygmomanometer) at 6 months and 1 year 2. Requirement of antihypertensive medications (at 3 months, 6 months and 1 year) measured using patient records 3. Metabolic parameters at baseline, 3 months, 6 months and 1 year: 3.1. Height (cm), Weight (kg), BMI (kg/m²), waist circumference (cm), visceral fat (MRI) 3.2. Lipid profile lipoprotein, apolipoprotein, insulin resistance (fasting blood sugar and insulin level), thyroid profile, testosterone, measured by a blood test 4. Inflammatory markers. Complete blood count with ESR, hsCRP, uric acid at baseline, 3 months, 6 months and 1 year. 5. Hypertension mediated organ damage (Brain, cardiac, kidney and eye) assessment: 5.1. Cardiac parameters. ECG, Echocardiography, carotid Intimal Media Thickness (cIMT), NT pro BNP. Baseline, 3 months, 6 months and 1 year 5.2. Eye assessment. Fundus examination (for hypertensive retinopathy). baseline, 1 year and 2 years 5.3. Neurological assessment using Montreal Cognitive assessment (in patients 60 years and above) assessed at baseline and 1 year. 5.4. Renal assessment (Blood urea, serum creatinine, eGFR and albumin creatinine ratio) Baseline, 3 months, 6 months and 1 year 6. Major adverse cardiac outcomes such as occurrence of MI, stroke if any throughout the study period measured using patient records 7. Safety outcomes (adverse effects, abnormal changes in blood investigations, frequency of uncontrolled hypertension, hospital admissions due to uncontrolled blood pressure etc) 1 year measured using patient records 8. Improvement in quality of life. SF-36. Baseline, 3 months, 6 months and 1 year 9. Treatment satisfaction. Treatment satisfaction questionnaire. Baseline, 3 mont | — |
Countries
India
Contacts
Public ContactParamesh Shamanna
Outcome results
None listed