Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Twin Precision Treatment: Patients randomized to the intervention group will follow the medicine, exercise, sleep, and nutritional syntax of the Twin Precision Treatment program. The du
Sponsors
TWINS DIGITAL SERVICES INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Patients with 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) Age 18 years and above Of either gender Willing to follow study specific activities and able to handle smartphone
Exclusion criteria
Exclusion criteria: Key exclusion criteria Uncontrolled hypertension ( > 180/110 mm of Hg) H/o hypertensive emergency requiring admission / Resistant Hypertension Diabetes mellitus Major Gastrointestinal diseases such as Inflammatory bowel disease, irritable bowel syndrome that can interfere with dietary intervention Use of contraindicated drugs such as antacids of magnesium, calcium, steroids, lithium, anti-migraine drugs, phenytoin, anti-psychotics (SSRI, SNRI, and TCA), immuno-modulators, any narcotic drugs, and oral contraceptives. Having received any investigational drug or device within 30 days prior to entry into the study Poor compliance during screening or run in. Autoimmune disorders and Connective tissue disorders Total bilirubin of > 2 mg/dL or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 5 times the upper limit of normal range Pregnant or planning to conceive in the next 3 years or breastfeeding Psychiatric illness such as psychosis, manic depressive illness, alcohol or drug dependence . Consumption of >14 alcoholic beverages per week (for women) and > 21 for men Any other condition or illness which the investigator feels would make the patient ineligible or make the patient difficult to participate in the study Any major cardiovascular event in the last 6 months (such as MI, stroke, TIA) Hypertensive Retinopathy (grade 3 and above) Weight loss more than 5% in 3 months Arm circumference too large or small to allow accurate BP measurement with available devices Special dietary requirements,or medications that would affect blood pressure (other than antihypertensive drugs) or nutrient metabolism Unwilling or inability to modify current diet Hypercalcemia ( > 10.5 mg/dl) and Hyperkalemia.( >5.5 mmol/l) Known Malignant cases Anemia (Hb Heart failure with EF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be change in blood pressure as measured by 24-hour ambulatory blood pressure monitoring at the end of 1 year Primary outcome will be a change in blood pressure as measured in the clinic at the end of 1 yearTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood pressure 6 months and two years post-randomization. Requirement of antihypertensive medications. Change in metabolic parameters Inflammatory markers Hypertension mediated organ damage (Brain, cardiac, kidney, and eye) assessment. Major adverse Cardiac outcomes Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Paramesh Shamanna
Bangalore Diabetes Centre
Outcome results
None listed