ISRCTN17705472进行中（未招募）未知
Efficacy and safety of Twin Precision treatment in patients with hypertension - a multicentre, open-label, randomised controlled trial
Twin Health0 个研究点目标入组 300 人开始时间: 2022年4月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 <40%
- •5. Chronic kidney disease (eGFR less than 60 ml/min/1.73 m²) or history of any major renal anomalies like unilateral kidney, polycystic kidney
- •6. Any major cardiovascular event in the last 6 months (such as MI, stroke, TIA)
- •7. Hypertensive Retinopathy (grade 3 and above)
- •8. Weight loss more than 5% in 3 months
- •9. Arm circumference too large or small to allow accurate BP measurement with available devices
- •10. Special dietary requirements, or medications that would affect blood pressure (other than antihypertensive drugs) or nutrient metabolism
- •11. Unwilling or inability to modify current diet
- •12. Hypercalcemia (>10.5 mg/dl) and Hyperkalemia.(>5.5 mmol/l)
- •13. Known Malignant cases <5 years
- •14. Anemia (Hb <8 gm)
- •15. Major Gastrointestinal diseases such as Inflammatory bowel disease, irritable bowel syndrome that can interfere with dietary intervention
- •16. 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.
- •17. Having received any investigational drug or device within 30 days prior to entry into the study
- •18. Poor compliance during screening or run in.
- •19. Autoimmune disorders and Connective tissue disorders
- •20. Total bilirubin of >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
研究者
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