TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension (TRIUMPH): Study protocol.
BACKGROUND
Hypertension management strategies have traditionally focused on "tailored therapy" and "stepped-care" approaches. These tend to be costly and time consuming and often fail to achieve adequate blood pressure (BP) control. The TRIUMPH study aims to investigate the effectiveness, cost-effectiveness, and acceptability of early use of a 3-in-1 BP-lowering pill ("Triple Pill") compared with usual care for the management of hypertension.


METHODS
The prospective, open, randomized controlled clinical trial (n = 700) will compare Triple Pill-based strategy to usual care among individuals with persistent mild-to-moderate hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg, or systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg in patients with diabetes or chronic kidney disease) on no or minimal drug therapy. The study will be conducted within approximately 20 hospital-based clinics in India. Participants will be randomized to the Triple Pill (initially strength 1-telmisartan 20 mg, amlodipine 2.5 mg, hydrochlorothiazide 6.25 mg, with the option of subsequent titration to strength 2-telmisartan 40 mg, amlodipine 5 mg, hydrochlorothiazide 12.5 mg) or continued usual care. Participants will be followed up for 6 months. The primary outcome is the proportion of participants achieving target BP at the end follow-up.


CONCLUSIONS
This study will determine whether early use of a low-dose triple combination therapy has the potential to address some of the challenges in hypertension control through earlier achievement of BP control, better adherence, and fewer adverse effects, in the context of less intensive clinical follow-up.
The George Institute for Global Health, Hyderabad, India; The George Institute for Global Health, Sydney, Australia; School of Public Health, The University of Sydney, Sydney, Australia.
Abdul
A
Salam
The George Institute for Global Health, Sydney, Australia; University of Sydney, Sydney, Australia. Electronic address: rwebster@georgeinstitute.org.
Ruth
R
Webster
Centre for Chronic Disease Control, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India.
Kavita
K
Singh
The George Institute for Global Health, Hyderabad, India.
Sudha
S
Kallakuri
The George Institute for Global Health, Sydney, Australia; University of Sydney, Sydney, Australia.
Anthony
A
Rodgers
Centre for Chronic Disease Control, New Delhi, India.
Dorairaj
D
Prabhakaran
The George Institute for Global Health, Hyderabad, India; The George Institute for Global Health, University of Oxford, Oxford, United Kingdom.
Pallab K
PK
Maulik
The George Institute for Global Health, Sydney, Australia; University of Sydney, Sydney, Australia.
Stephen
S
Jan
International Centre for Circulatory Health, Imperial College London, London, United Kingdom.
Simon
S
Thom
All India Institute of Medical Sciences, New Delhi, India.
Nitish
N
Naik
The George Institute for Global Health, Hyderabad, India.
Rama
R
Guggilla
School of Population Health, The University of Auckland, Auckland, New Zealand.
Vanessa
V
Selak
The George Institute for Global Health, Hyderabad, India; The George Institute for Global Health, Sydney, Australia; University of Sydney, Sydney, Australia.
Anushka
A
Patel
D000328:Adult; D017311:Amlodipine / Q000008:administration & dosage*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage; D001562:Benzimidazoles / Q000008:administration & dosage*; D001565:Benzoates / Q000008:administration & dosage*; D001794:Blood Pressure / Q000502:physiology*; D002121:Calcium Channel Blockers / Q000008:administration & dosage; D004232:Diuretics / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage*; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D000077333:Telmisartan; D016896:Treatment Outcome
D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D002121:Calcium Channel Blockers; D004232:Diuretics; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000077333:Telmisartan