DOFETILIDE IN PATIENTS WITH LEFT-VENTRICULAR DYSFUNCTION AND EITHER HEART-FAILURE OR ACUTE MYOCARDIAL-INFARCTION - RATIONALE, DESIGN, AND PATIENT CHARACTERISTICS OF THE DIAMOND STUDIES
Aj. Camm et al., DOFETILIDE IN PATIENTS WITH LEFT-VENTRICULAR DYSFUNCTION AND EITHER HEART-FAILURE OR ACUTE MYOCARDIAL-INFARCTION - RATIONALE, DESIGN, AND PATIENT CHARACTERISTICS OF THE DIAMOND STUDIES, Clinical cardiology, 20(8), 1997, pp. 704-710
Background: Attempts to prolong life with antiarrhythmic drugs in pati
ents at increased risk of sudden cardiac death have so far been disapp
ointing or inconclusive. Hypothesis: The Danish Investigations of Arrh
ythmia and Mortality ON Dofetilide (DIAMOND) encompass two survival st
udies testing the prophylactic use of the selective potassium-channel
blocker, dofetilide, in patients at high risk of sudden death. Methods
: The first study includes patients admitted to hospital with congesti
ve heart failure (CI-IF), the other includes patients with acute myoca
rdial infarction (MI) within the previous 7 days. In both studies pati
ents must have left ventricular systolic dysfunction (ejection fractio
n less than or equal to 35%) determined by echocardiography. Each of t
he two studies are planned to enroll 1500 patients. Consecutive hospit
alized patients with MI or CHF are screened in 37 Danish hospitals. El
igible patients are randomized to receive dofetilide or matching place
bo. All patients are continuously monitored by telemetry for the first
3 days of the study to detect possible arrhythmic events and to ensur
e resuscitation in case of serious arrhythmias. Minimum duration of fo
llow-up is 12 months. Results: Between November 1993 and July 1996, a
total of 5812 consecutive patients with CHF and 8688 consecutive patie
nts with MI was screened for entry. Of these, 1518 patients were inclu
ded in the CHF study and 1510 patients in the MI study. Overall I-year
mortality of randomized patients were 28 and 22%, respectively. Concl
usion: DIAMOND will provide important data on the safety and efficacy
of dofetilide in high-risk patients with left ventricular dysfunction
and either CHF or MI, as well as evaluate tolerability in these popula
tions.