The ADOPT trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China): rationale, design, and end-points
Bing Liu1*, Fu Yi1*, Hongwei Cai2, Wenyi Guo1, Weijie Li1, Min Shen1, Jielai Xia3, Liwen Liu4, Haichang Wang1, on behalf of The ADOPT Study Steering Committee and Investigators
1Department of Cardiology, Xijing Hospital, FMMU, Xi’an, China; 2Department of Information, School of Stomatology, FMMU, Xi’an, China; 3Department of Statistics, FMMU, Xi’an, China; 4Department of Ultrasound, Xijing Hospital, FMMU, Xi’an, China
ClinicalTrials.gov number, NCT01018667
*Both authors contributed equally to this work
Background: Cardiac resynchronization therapy (CRT) is a novel nonpharmacological treatment for patients with chronic heart failure (CHF). Some clinical trials conducted in Western countries have demonstrated that CRT could improve CHF patients’ symptoms and reduce mortality. However, due to the differences in economic and social conditions as well as inconsistencies in CHF etiologies between China and Western countries, there is an urgent need to conduct a large-scale CRT clinical study in Chinese patients with CHF. The ADOPT Trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China) is designed to observe whether CRT can further improve syptoms and reduce mortality in Chinese patients in addition to optimal pharmalogical therapy.
Methods: The ADOPT study is a prospective, nested, case-controlled, open-label clinical trial. About 40 centers across China participate in this study with a planned 800 Chinese cases to be enrolled. All patients will receive optimal medical treatment. Patients who have successful CRT-P/D implant will be assigned to the CRT group. According to the baseline evaluation, matched cases will be selected from the enrolled optimal pharmaceutical therapy alone group (Group for Selection). After successful match, the cases in Group for Selection enter into follow-up and become the control group. The unmatched cases in the Group for Selection will be removed. If patients agree, after re-evaluation of the baseline situation, they may enter into Group for Selection again. Since patients know they already have a device implant and the examiners are aware of the grouping of the patients after seeing the incision scar and post-implant electrocardiogram, this study is of open-label design; however the executive committee will be kept blind when making event-adjudication.
Results: Prospectively defined primary end-points for the study include combined all-cause mortality and hospitalizations. A variety of secondary end-points will further define the efficacy and mechanism(s) of action of CRT in CHF. The last date of the study shall be the day after 24 months of follow-up of the last enrolled patient. Recruitment is expected to be completed at the end of 2011 and the study should close at the beginning of 2014.
Conclusion: The ADOPT trial will evaluate the effects of CRT on Chinese CHF patients and provide related research data for Chinese CHF patients who may need CRT.
Keywords: heart failure, clinical trial, biventricular pacing, cardiac device
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