Valsartan cardio-renal protection in patients undergoing coronary angiography complicated with chronic renal insufficiency (VAL-CARP) trial: rationale and design.
BACKGROUND
Despite an increase in the frequency of coronary angiography (CAG) in Japan, the exact incidence of contrast-induced nephropathy (CIN) remains unknown in the Japanese population, especially in patients with chronic renal insufficiency. In addition, the nature of pharmacological interventions that would benefit the patients before or after procedures such as coronary bypass graft (CABG) and percutaneous coronary intervention (PCI) has not been fully investigated.


METHODS
In the trial 500 patients with renal insufficiency (defined as a glomerular filtration rate (GFR) of between 89 and 30 ml . min(-1) . (1.73 m(-2)) following CAG will be randomly assigned to receive either valsartan, an angiotensin receptor blocker or angiotensin converting enzyme (ACE) inhibitor plus valsartan.1 The primary end-point is a change in the GFR of patients, which will be followed up for 3 years, including following CABG surgery or PCI. The incidence of cardiac events as well as the adverse effects of pharmacological intervention will be evaluated. In addition, the incidence of renal artery stenosis at the time of CAG will be reported also; however, the patients with renal artery stenosis will be excluded from the present study.


CONCLUSIONS
The present study will provide data on: 1) the exact incidence and course of renal function of CIN after CAG; and 2) the comparative therapeutic benefit of pharmacological intervention with valsartan alone or with valsartan and an ACE inhibitor in combination in patients with coexisting coronary artery diseases and chronic renal insufficiency, regardless of whether they receive CABG or PCI. In addition to these studies, an estimate of the incidence of renal artery stenosis in these patients will be demonstrated.
Ikeda
Naofumi
N
Department of Nephrology, Saitama Medical School, Saitama, Japan. n_ikeda@saitama-med.ac.jp
Nishimura
Shigeyuki
S
Kyo
Shunei
S
Komiyama
Nobuyuki
N
Matsumoto
Kazuo
K
Inoue
Tsutomu
T
Suzuki
Hiromichi
H
D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D002985:Clinical Protocols; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications* / Q000188:drug therapy; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D020011:Protective Agents / Q000627:therapeutic use; D012078:Renal Artery Obstruction; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000188:drug therapy; D013777:Tetrazoles / Q000008:administration & dosage*; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000068756:Valsartan
D047228:Angiotensin II Type 1 Receptor Blockers; D000806:Angiotensin-Converting Enzyme Inhibitors; D020011:Protective Agents; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine