Blood pressure reduction in patients with high blood pressure (hypertension) with diet and lifestyle modification
| ISRCTN | ISRCTN17705472 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17705472 |
| Secondary identifying numbers | TPT- 4/2021 |
- Submission date
- 24/01/2022
- Registration date
- 25/04/2022
- Last edited
- 25/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
High blood pressure (BP) is the leading cause of heart disease and early deaths worldwide. According to WHO, globally, 1.13 billion people have high BP, and it was estimated in 2015 that every 1 in 4 males and 1 in 5 females had high BP. Diet based therapy and lifestyle modifications serve as the first line of treatment for prevention as well as to control blood pressure in the early stage.
The Twin Health platform uses a Whole Body Digital Twin, powered by artificial intelligence and Internet of Things technology, to precisely understand the metabolic impairment in the patient’s body, which is unique to the patient. The platform collects data from body sensors and a mobile app to track and analyze the body's health signals in order to personalize patients' treatment.
Who can participate?
Adults above 18 years of age with hypertension.
What does the study involve?
Participants will be randomly allocated to receive treatment as usual or the Twin Precision treatment program for 2 years. Participants will be followed up 1 year later.
What are the possible benefits and risks of participating?
Possible benefits from the program include a reduction in blood pressure.
Possible risks will be monitored throughout by the patients’ caregivers and necessary steps will be taken to help keep glucose and fluid/electrolyte levels normal.
Where is the study run from?
Bangalore Diabetes Centre (India)
When is the study starting and how long is it expected to run for?
January 2022 to January 2025
Who is funding the study?
Twin health (India)
Who is the main contact?
Dr Paramesh Shamanna, drparamesh2@gmail.com
Contact information
Principal Investigator
426, CMR Main Rd
HRBR Layout 2nd Block
Kalyan Nagar
Bengaluru
560043
India
 ORCID ID |
0000-0002-0693-4483 |
|---|---|
| Phone | +91 80 4347 9444 |
| paramesh@twinhealth.com |
Study information
| Study design | Multicentric open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | Efficacy and safety of Twin Precision treatment in patients with hypertension - a multicentre, open-label, randomised controlled trial |
| Study acronym | TPT |
| Study objectives | To compare the mean change in systolic and diastolic 24 hr blood pressure ambulatory from baseline to 1 year between the 2 groups. To compare the mean change in systolic and diastolic blood pressure clinic based from baseline to 1 year between the 2 groups. |
| Ethics approval(s) | Approved 08/01/2022, Medisys Clinisearch Ethical Review Board (Medisys Clinisearch India Private Limited, Bangalore Diabetes Center, No. 426, 4th Cross, 2nd Block, Kalyan Nagar, Bangalore - 560043, Karnataka, India; +91 80 2542 1333; bhargavicrc@gmail.com), ref: none provided |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | 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 Lifestyle modifications and medications as per current guidelines (ISH). Group 2 Intervention arm (Twin Precision treatment) The platform collects data from body sensors and a mobile app to track and analyze the body's health signals to personalize patients' treatment. Individualized medicine, exercise, sleep and nutritional syntax of the Twin Precision Treatment program guided by artificial intelligence will be administered. Duration of intervention 2 years Duration of follow up 1 year Randomisation Patients will be randomized into either the standard care arm or the intervention arm using central randomisation in a ratio of 1:2 (standard arm: intervention arm). Block randomisation of variable block size or in other words, random permuted blocks will be used where the size of the next block will be randomly chosen from the available block sizes. Since the randomization ratio is 1:2, the random permuted blocks of sizes 3 or multiples of 3 will be selected. Random numbers and sequences will be generated through an online tool which is given by sealed envelope.com. Since block randomization is done by varying block sizes, the permutation of sequences may not be identified to reduce the bias. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 08/01/2022 |
| Completion date | 14/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key 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 |
| Key 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 <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 |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- India
Study participating centres
HRBR Layout 2nd Block
Kalyan Nagar
Bengaluru
560043
India
Road Bangalore - 560057, Karnataka, India
Bangalore
560057
India
Sponsor information
Other
2nd Floor, 420, 4th Cross Rd
HRBR Layout 2nd Block
Sena Vihar
Kalyan Nagar
Bengaluru
560043
India
| Phone | +91 9481997200 |
|---|---|
| hello@twinhealth.com | |
| Website | https://ind.twinhealth.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All of the individual participant data collected during the trial, after de-identification data will be shared Name- Dr Paramesh Shamanna Email- paramesh@twinhealth.com Data type- Digital format in Twin ICAP Data availability - 3 years from the start of Trial Data accessibility: Data will be accessible in digital format after the consent is obtained from participants and participant identity will be anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1.1 | 09/03/2022 | 20/04/2022 | No | No |
| Statistical Analysis Plan | 20/04/2022 | No | No |
Additional files
Editorial Notes
20/04/2022: Trial's existence confirmed by Medisys Clinisearch Ethical Review Board
