Efficacy and safety of Twin Precision treatment in patients with hypertensio

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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 < 5 years

Anemia (Hb < 8 gm)

Heart failure with EF < 40%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome will be change in blood pressure as measured by 24-hour ambulatory blood pressure monitoring at the end of 1 year <br/ ><br>Primary outcome will be a change in blood pressure as measured in the clinic at the end of 1 yearTimepoint: 2 years

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure 6 months and two years post-randomization. <br/ ><br>Requirement of antihypertensive medications. <br/ ><br>Change in metabolic parameters <br/ ><br>Inflammatory markers <br/ ><br>Hypertension mediated organ damage (Brain, cardiac, kidney, and eye) assessment. <br/ ><br>Major adverse Cardiac outcomes <br/ ><br> <br/ ><br>Timepoint: 2 years