Danish ICD Study in Patients With Dilated Cardiomyopathy (NCT00542945) | Clinical Trial Compass
CompletedNot Applicable
Danish ICD Study in Patients With Dilated Cardiomyopathy
Denmark1,116 participantsStarted 2008-03
Plain-language summary
The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause in patients with heart failure of non-ischemic oetiology.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 years of age at the time of screening.
* Documented non-ischemic HF with an LVEF ≤ 35%.
* NYHA class II-III. If patients are planned for an implantation with a biventricular pacemaker NYHA class IV patients will be accepted for the trial.
* Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained (see section 12.1).
* NT-proBNP above 200 pg/ml (see appendix D).
Exclusion Criteria:
To be eligible for this study, subjects must not meet any of the following criteria:
* Uncorrected congenital heart disease or valve obstruction, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
* On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
* Recipient of any major organ transplant (eg, lung, liver, heart or kidney).
* Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomisation or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized diseas…