© 2000 European Society of Cardiology
Survival and Prognosis: Investigation of Crataegus Extract WS 1442 in congestive heart failure (SPICE) — rationale, study design and study protocol
a Medizinische Klinik und Poliklinik, Abt. Innere Medizin III – Kardiologie und Angiologie Hugstetter Str. 55, D-79106 Freiburg, Germany
b Cardiology Department, Boston Medical Center 88 E Newton Street, Boston, MA 02118, USA
c Universitätskrankenhaus Eppendorf Medizinische Klinik, Abt. für Kardiologie, Martinistr 52, D-20246 Hamburg, Germany
d Universität Ulm, Abt. Biometrie und Medizinische Dokumentation Schwabstr. 13, D-89075 Ulm-Donau, Germany
e 3rd Division of Cardiology, Silesian School of Medicine Ziolowa 47, PL-40-635 Katowice, Poland
* Corresponding author. Tel.: +49-761-2703401; fax: +49-761-2703611. E-mail address: holubarsch{at}mm31.ukl.uni_freiburg.de (C.J. Holubarsch).
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Abstract |
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SPICE is the first, international, randomized, placebo-controlled, double-blind study to investigate the influence of the herbal drug Crataegus Special Extract WS 1442 (hawthorn leaves with flowers) on mortality of patients suffering from congestive heart failure.
Background: In vitro and experimental animal studies have suggested the following pharmacological modes of action of standardized Crataegus extracts: (1) cAMP-independent positive inotropy; (2) peripheral and coronary vasodilation; (3) protection against ischemia-induced ventricular arrhythmias; (4) antioxidative properties; and (5) anti-inflammatory effects.
Study design: In this randomized, placebo-controlled, double-blind, international trial (approximately 120 investigational centers in seven European countries), up to 2300 patients with congestive heart failure, New York Heart Association class II and III and markedly impaired left ventricular function, will be enrolled and treated over a period of 24 months. During this time patients receive either two film-coated tablets of 450 mg of the Special Extract WS 1442 standardized to 84.3 mg of oligomeric procyanidines or matched placebo per day in addition to standard therapy for congestive heart failure, such as diuretics, digoxin or digitoxin, β-adrenoceptor blockers and angiotensin-converting-enzyme inhibitors. The primary outcome variable is the combined endpoint of cardiac death, non-lethal myocardial infarction, and hospitalization due to progression of heart failure. Secondary outcome variables are total mortality, exercise duration, echocardiographic parameters, quality of life as well as pharmacoeconomic parameters. The first patient was included in October 1998. The trial is expected to be completed at the end of 2002.
Received February 23, 2000; Revised June 1, 2000; Accepted June 20, 2000
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