Abdul Salam1, Ruth Webster2, Kavita Singh3, Sudha Kallakuri4, Anthony Rodgers5, Dorairaj Prabhakaran6, Pallab K Maulik7, Stephen Jan5, Simon Thom8, Nitish Naik9, Rama Guggilla4, Vanessa Selak10, Anushka Patel11. 1. 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. 2. The George Institute for Global Health, Sydney, Australia; University of Sydney, Sydney, Australia. Electronic address: rwebster@georgeinstitute.org. 3. Centre for Chronic Disease Control, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India. 4. The George Institute for Global Health, Hyderabad, India. 5. The George Institute for Global Health, Sydney, Australia; University of Sydney, Sydney, Australia. 6. Centre for Chronic Disease Control, New Delhi, India. 7. The George Institute for Global Health, Hyderabad, India; The George Institute for Global Health, University of Oxford, Oxford, United Kingdom. 8. International Centre for Circulatory Health, Imperial College London, London, United Kingdom. 9. All India Institute of Medical Sciences, New Delhi, India. 10. School of Population Health, The University of Auckland, Auckland, New Zealand. 11. The George Institute for Global Health, Hyderabad, India; The George Institute for Global Health, Sydney, Australia; University of Sydney, Sydney, Australia.
Abstract
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 careamong individuals with persistent mild-to-moderate hypertension (systolic BP >140 mmHg 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. CONCLUSION: 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.
RCT Entities:
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. CONCLUSION: 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.
Authors: Abdul Salam; Ruth Webster; Anushka Patel; Pavithra Godamunne; Arunasalam Pathmeswaran; H Asita de Silva; Anthony Rogers; Stephen Jan; Tracey-Lea Laba Journal: BMJ Open Date: 2018-08-17 Impact factor: 2.692
Authors: David Peiris; Simon R Thompson; Andrea Beratarrechea; María Kathia Cárdenas; Francisco Diez-Canseco; Jane Goudge; Joyce Gyamfi; Jemima Hoine Kamano; Vilma Irazola; Claire Johnson; Andre P Kengne; Ng Kien Keat; J Jaime Miranda; Sailesh Mohan; Barbara Mukasa; Eleanor Ng; Robby Nieuwlaat; Olugbenga Ogedegbe; Bruce Ovbiagele; Jacob Plange-Rhule; Devarsetty Praveen; Abdul Salam; Margaret Thorogood; Amanda G Thrift; Rajesh Vedanthan; Salina P Waddy; Jacqui Webster; Ruth Webster; Karen Yeates; Khalid Yusoff Journal: Implement Sci Date: 2015-11-09 Impact factor: 7.327