Comparison of nephrotoxic effects of the contrast dyes iodixanol (iso-osmolar, non-ionic, dimer) and ioversol (low-osmolar, non-ionic, monomer) in patients with impaired renal function and severe heart failure
- Conditions
- Coronary angiography in patients with known coronary artery disease
- Registration Number
- EUCTR2004-004086-15-DE
- Lead Sponsor
- niversity Hospital of Frankfurt, Department of Cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
- Patients must be older than 18 y.o.
- Written consent to the study
- Coronary angiography is required for medical reasons
- Calculated glomerular filtration rate = 60 ml/min (calculation is based on the shortened MDRD-formula)
- Severe heart failure, diagnosed either by an ejection fraction = 45 % (echocardiography) or a clinical condition NYHA III or IV
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Severe comorbidity (i.e. neoplasia, life expectaning = 2 yrs.)
- Intravacular administration of iodinated contrast dye within last 14 days
- Intake of nephrotoxic drugs within the last 7 days
- Intake of metformine within the last 24 hours
- Patients with prior renal transplantation
- End-stage renal disease or acute renal failure and/or necessity of dialysis after coronary angiography
- Pregnancy or lactation
- Impaired liver function following the Child-Pugh criteria according a severity level of Child B or C
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method