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The Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF)

Åke Hjalmarson, MD, PhD; Sidney Goldstein, MD; Björn Fagerberg, MD, PhD; Hans Wedel, PhD; Finn Waagstein, MD, PhD; John Kjekshus, MD, PhD; John Wikstrand, MD, PhD; Dia El Allaf, MD; Jirí Vítovec, MD, PhD; Jan Aldershvile, MD, PhD; Matti Halinen, MD, PhD; Rainer Dietz, MD; Karl-Ludwig Neuhaus, MD; András Jánosi, MD, DSc; Gudmundur Thorgeirsson, MD, PhD; Peter H. J. M. Dunselman, MD, PhD; Lars Gullestad, MD; Jerzy Kuch, MD; Johan Herlitz, MD, PhD; Peter Rickenbacher, MD; Stephen Ball, MD, PhD; Stephen Gottlieb, MD; Prakash Deedwania, MD; for the MERIT-HF Study Group

JAMA. 2000;283:1295-1302.

Context  Results from recent studies on the effects of ₁-blockade in patients with heart failure demonstrated a 34% reduction in total mortality. However, the effect of ₁-blockade on the frequency of hospitalizations, symptoms, and quality of life in patients with heart failure has not been fully explored.

Objective  To examine the effects of the ₁-blocker controlled-release/extended-release metoprolol succinate (metoprolol CR/XL) on mortality, hospitalization, symptoms, and quality of life in patients with heart failure.

Design  Randomized, double-blind controlled trial, preceded by a 2-week single-blind placebo run-in period, conducted from February 14, 1997, to October 31, 1998, with a mean follow-up of 1 year.

Setting  Three hundred thirteen sites in 14 countries.

Participants  Patients (n = 3991) with chronic heart failure, New York Heart Association (NYHA) functional class II to IV, and ejection fraction of 0.40 or less who were stabilized with optimum standard therapy.

Interventions  Patients were randomized to metoprolol CR/XL, 25 mg once per day (NYHA class II), or 12.5 mg once per day (NYHA class III or IV), titrated for 6 to 8 weeks up to a target dosage of 200 mg once per day (n = 1990); or matching placebo (n = 2001).

Main Outcome Measures  Total mortality or any hospitalization (time to first event), number of hospitalizations for worsening heart failure, and change in NYHA class, by intervention group; quality of life was assessed in a substudy of 741 patients.

Results  The incidence of all predefined end points was lower in the metoprolol CR/XL group than in the placebo group, including total mortality or all-cause hospitalizations (the prespecified second primary end point; 641 vs 767 events; risk reduction, 19%; 95% confidence interval [CI], 10%-27%; P<.001); total mortality or hospitalizations due to worsening heart failure (311 vs 439 events; risk reduction, 31%; 95% CI, 20%-40%; P<.001), number of hospitalizations due to worsening heart failure (317 vs 451; P<.001); and number of days in hospital due to worsening heart failure (3401 vs 5303 days; P<.001). NYHA functional class, assessed by physicians, and McMaster Overall Treatment Evaluation score, assessed by patients, both improved in the metoprolol CR/XL group compared with the placebo group (P = .003 and P = .009, respectively).

Conclusions  In this study of patients with symptomatic heart failure, metoprolol CR/XL improved survival, reduced the need for hospitalizations due to worsening heart failure, improved NYHA functional class, and had beneficial effects on patient well-being.

Author Affiliations: Department of Cardiology (Drs Hjalmarson, Waagstein, and Herlitz) and Wallenberg Laboratory for Cardiovascular Research (Drs Fagerberg and Wikstrand), Sahlgrenska University Hospital, and the Nordic School of Public Health (Dr Wedel), Göteborg, Sweden; Henry Ford Hospital, Detroit, Mich (Dr Goldstein); Department of Medicine, Rikshospitalet, Oslo, Norway (Drs Kjekshus); Baerums Sykehus, Baerum, Norway (Dr Gullestad); Service de Cardiologie et de Réanimation Cardiaque, Centre Hospitalier Hutois, Huy, Belgium (Dr El Allaf); 2 Interní Klinika, Fakultní Nemocnice, Brno, Czech Republic (Dr Vítovec); Department of Medicine B, Rigshospitalet, Copenhagen, Denmark (Dr Aldershvile); Accident and Emergency Department, Kuopio University Hospital, Kuopio, Finland (Dr Halinen); Franz-Volhard Klinik, Charité Campus, Berlin-Buch, Germany (Dr Dietz); Klinikum-Kassel, Medizinische Klinik II, Kassel, Germany (Dr Neuhaus); Szent János Hospital, Budapest, Hungary (Dr Jánosi); Department of Medicine, Landspítalinn, University Hospital, Reykjavík, Iceland (Dr Thorgeirsson); Department of Cardiology, St Ignatius Ziekenhuis, Breda, the Netherlands (Dr Dunselman); Department of Cardiology, Warsaw School of Medicine, Warsaw, Poland (Dr Kuch); Kardiologie, Kantonsspital Bruderholz, Bruderholz, Switzerland (Dr Rickenbacher); Institute for Cardiovascular Research, Leeds General Infirmary, Leeds, England (Dr Ball); Division of Cardiology, University of Maryland, Baltimore (Dr Gottlieb); and the Department of Veterans Affairs Medical Center, Fresno, Calif (Dr Deedwania).

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