A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease (the DANREHAB trial)--design, intervention, and population.
BACKGROUND
Current guidelines broadly recommend comprehensive cardiac rehabilitation (CR), although evidence for this is still limited. It is not known whether evidence from before 1995 is still valid.


METHODS
The DANish Cardiac ReHABilitation (DANREHAB) trial was designed as a centrally randomized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure, ischemic heart disease, or high risk for ischemic heart disease. A combined primary outcome measure included total mortality, myocardial infarction, or readmissions due to heart disease based on linkage to public registries. The CR was an individually tailored, multidisciplinary program (6 weeks of intensive CR and 12 months of follow-up) including patient education, exercise training, dietary counseling, smoking cessation, psychosocial support, risk factor management, and clinical assessment.


METHODS
Of 5060 discharged patients, 1614 (32%) were eligible for the trial and 770 patients were randomized (47% of those eligible). Participants were younger (P < .001) and had less comorbidity than nonparticipants (P < .03).


CONCLUSIONS
Our trial shows that a large-scale, centrally randomized clinical trial on comprehensive CR can be conducted among a broadly defined patient group, but reaching the stipulated number of 1800 patients was difficult. Although the study included relatively many women and older people, elderly patients and patients with high comorbidity were underrepresented, which may influence the external validity.
Zwisler
Ann-Dorthe Olsen
AD
Department of Cardiology, H:S Bispebjerg Hospital, Copenhagen, Denmark. ado@niph.dk
Schou
Lone
L
Soja
Anne Merete Boas
AM
Brønnum-Hansen
Henrik
H
Gluud
Christian
C
Iversen
Lars
L
Sigurd
Bjarne
B
Madsen
Mette
M
Fischer-Hansen
Jørgen
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006333:Heart Failure / Q000534:rehabilitation* / Q000628:therapy; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000534:rehabilitation* / Q000628:therapy; D012307:Risk Factors