The design of the mortality assessment in congestive heart failure trial (MACH-1, Mibefradil)

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Abstract
Background: Despite the advances in therapy for heart failure with the use of angiotensin‐converting enzyme inhibitors, heart failure remains a major medical problem, impacting on well‐being and survival. Hypothesis: Mibefradil is a member of new class of agents that, due to its unique mechanism of action and pharmacologic and physiologic profile, may offer a significant advance in the treatment of heart failure. Mibefradil is a nonvoltage‐regulated T‐channel calcium blocker that differs from all the other currently available L‐channel calcium blockers. The drug is a potent peripheral and coronary vasodilator, with no clinical negative inotropic activity. Furthermore, because of its long half‐life, it can be given once a day and appears to be free of the common side effects seen with other calcium‐channel blockers. The trial was designed to investigate whether the addition of mibefradil to standard therapy for heart failure will reduce mortality in patients with symptomatic heart failure. Methods: This manuscript describes the design, organization, and status of MACH‐1 (Mortality Assessment in Congestive Heart Failure), a double‐blind, placebo‐controlled study. It is to be a 2,400‐patient international trial assessing the ability of mibefradil to impact upon survival and symptoms of heart failure in patients who are in NYHA classes II–IV and who were already treated with standard therapy.