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

Conditions

None listed

Brief summary

The study is a prospective, open, randomised controlled clinical trial (n=700) of a combination blood pressure lowering pill (“Triple Pill”)-based strategy compared to usual care among individuals with newly diagnosed hypertension on no or minimal drug therapy, augmented by a cost-effectiveness analysis and a formal process evaluation. The key hypothesis tested is that there is no difference in the proportion of patients reaching their target blood pressure at 6 months compared to usual care.

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

Association of Low-Dose Triple Combination Therapy With Therapeutic Inertia and Prescribing Patterns in Patients With Hypertension

Nelson Wang, Abdul Salam, Ruth Webster, Asita de Silva, Rama Guggilla et al. (17 authors)

JAMA Cardiology2020-07-2229 citations

10.1001/jamacardio.2020.2739

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

Patients in the intervention arm will start on the lower dose of the drug under investigation with the option to move to the higher dose if blood pressure is not controlled to the responsible clinician's satisfaction. Each dose version is taken as one tablet once a day for a total period of 6 months. Components of each dose version are as follows: Low Dose: Telmisartan 20mg, Amlodipine 2.5mg, Chlorthalidone 12.5mg High Dose: Telmisartan 40mg, Amlodipine 5mg, Chlorthalidone 25mg

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* The investigator is satisfied that the patient has persistent hypertension (SBP>140mmHg and/or DBP>90mmHg; or SBP>130mmHg and/or DBP>80mmHg in patients with diabetes mellitus or chronic kidney disease) requiring initiation of pharmacological treatment (in patients not taking drug therapy) or up-titration of pharmacological treatment (in patients taking single drug therapy) *Trial Investigator is unsure as to whether a Triple Pill based therapy or usual care is better.

Exclusion criteria

*on 2 or more BP lowering drugs * severe or uncontrolled hypertension (SBP > 180mmHg and/or DBP > 110 mmHg) *Accelerated hypertension or hypertension at a level where the physician feels that slower up-titration of treatment is appropriate (e.g. elderly patients) *Contraindication to any of the components of the Triple Pill *Pregnancy, breast feeding, childbearing potential not on effective medically accepted method of child birth control. *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. *Participants with clinically significant abnormal laboratory value judged to be unsuitable for trial participation by the investigator.

Outcome results