TRIUMPH - TRIple Pill vs. Usual care Management for Patients with mild - to - moderate Hypertension

Conditions

Hypertension

Abdul Salam, Tracey‐Lea Laba, Rupasvi Dhurjati, Josyula K. Lakshmi, Asita de Silva et al. (16 authors)

BMJ Open2025-06-01

10.1136/bmjopen-2025-101689

Fixed Low-Dose Triple Combination Antihypertensive Medication vs Usual Care for Blood Pressure Control in Patients With Mild to Moderate Hypertension in Sri Lanka

Ruth Webster, Abdul Salam, H. Asita de Silva, Vanessa Selak, Sandrine Stepien et al. (29 authors)

JAMA2018-08-14183 citations

10.1001/jama.2018.10359

Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study

Abdul Salam, Ruth Webster, Anushka Patel, Pavithra Godamunne, A. Pathmeswaran et al. (9 authors)

BMJ Open2018-08-014 citations

10.1136/bmjopen-2018-022317

Interventions

Study setting : Specialist tertiary care centres Number of arms: Two Patients in the intervention arm will start on the lower dose of the drug under investigation with the option to move to the hig

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults 18 or more years of age 2. Persistent (6 weeks) SBP > 140 mmHg and/or DBP > 90 mmHg (or SBP > 130 mmHg and/or DBP > 80mmHg in patients with diabetes mellitus or chronic kidney disease) despite diet and lifestyle advice and/or the use of single BP lowering drug therapy. 3. Trial Investigator is unsure as to whether a Triple Pill based therapy or usual care is better.

Exclusion criteria

Exclusion criteria: 1. On two or more BP lowering drugs 2. Severe or uncontrolled BP (SBP > 180 mmHg and/or DBP > 110 mmHg) 3. Accelerated hypertension or hypertension at a level where the physician feels that slower up titration of treatment is appropriate (e.g. elderly patients) 4. Contraindication to any of the components of the Triple Pill 5. Pregnancy, breast feeding, childbearing potential and not on effective medically accepted method of child birth control. 6. Unstable medical condition or known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation, dialysis. 7. Participants with clinically significant abnormal laboratory value judged to be unsuitable for trial participation by the investigator.

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving target SBP < 140 mmHg and DBP< 90 mmHG (SBP < 130 mmHg and DBP < 80 mmHg for participants with diabetes and/ or chronic kidney disease) [6 months]	—

Secondary

Measure	Time frame
1.Proportion of participants with BP control at 6 and 12 weeks 2.Mean change in SBP and DBP 3.Tolerance to treatment (using a symptom diary) 4.use of health care services (hospitalizations, medical consultations, tests) 5.self - reported BP lowering medication use (7 day recall) 6.quality of life (using a standardized questionnaire) [1. At 6 weeks and 12 weeks 2. At 6 months 3. At 6 months 4. At 6 months 5. At 6 months 6. At 6 months ]	—

Measure

Time frame

1.Proportion of participants with BP control at 6 and 12 weeks 2.Mean change in SBP and DBP 3.Tolerance to treatment (using a symptom diary) 4.use of health care services (hospitalizations, medical consultations, tests) 5.self - reported BP lowering medication use (7 day recall) 6.quality of life (using a standardized questionnaire) [1. At 6 weeks and 12 weeks 2. At 6 months 3. At 6 months 4. At 6 months 5. At 6 months 6. At 6 months ]

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Countries

Sri Lanka

Contacts

Public ContactProf Senaka Rajapakse

Professor in Medicine & Consultant Physician

senaka@med.cmb.ac.lk, senaka.ucfm@gmail.comTel: +94-112 581 835

Outcome results

None listed