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The Changes of Biomarkers by Telmisartan and their Significance in Cardiovascular Outcomes: Design of a Trial of Telmisartan Prevention of Cardiovascular Diseases (ATTEMPT-CVD)

Hirofumi Soejima, Hisao Ogawa, Osamu Yasud, Shokei Kim-Mitsuyam, Kunihiko Matsui, Koichi Nod, Megumi Yamamuro, Eiichiro Yamamoto, Keiichiro Kataok, Hideaki Jinnouchi and Taiji Sekigami

Objective: Angiotensin II receptor blocker (ARB) has become first-line agent for the treatment of hypertensive patients because they are associated with an excellent effect for blood pressure control and a lower rate of occurrence of adverse reactions. To our knowledge, there is no report of the large-scale study that measures biomarkers in 1000 or more patients for long follow-up period. To compare the effects of ARB therapy and that of standard therapy except ARB on the changes of biomarker levels and the incidence of cardiovascular events, a trial of telmisartan prevention of cardiovascular diseases (ATTEMPT-CVD) was planned. Urinary albumin creatinine rates, plasma brain natriuretic peptide, serum high sensitivity c-reactive protein, urinary 8-hydroxy-deoxy-guanosine,
serum adiponectin, and high-molecular weight adiponectin were selected as biomarkers. These biomarkers are known to be predictive factors for cardiovascular event, renal dysfunction, or atherosclerosis.
Methods: ATTEMPT-CVD is a multicenter, prospective, randomized open-label, controlled trial with blinded endpoint assessment. High-risk patients with heart, peripheral, renal, or cerebrovascular disease or diabetes are being recruited and followed for 3 years. The randomization is performed as stratified randomization after age, gender, past history of disease and usage of angiotensin converting enzyme inhibitor are adjusted for. The biomarker assessment is performed at the start of the study (at registration), after 6, 12, 24 and 36 months from the start of the study. Furthermore, survey of general laboratory tests, cardiovascular events, adverse events, and drug compliance is also performed at the same point of biomarker assessment and after 3 months from the start of the study.
Conclusions: The ATTEMPT-CVD is the first large clinical trial focusing of the efficacy of ARB therapy on the relationship between prevention of cardiovascular event and the changes of biomarkers. This study will provide a novel insight into the significance of biomarkers considering the therapy on high-risk hypertensive patients.