PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: hydratation vs carbonates to prevent Contrast-Induced Nephropathy in patients undergoing coronary angiography or intervention at risk for Heart Failure (PREVENT-CIN HF). A prospective randomized trial.

INTERVENTION: Pharmaceutical Form: Solution for infusion INN or Proposed INN: SODIUM BICARBONATE CAS Number: 144‐55‐8 Concentration unit: ml millilitre(s) Concentration type: up to Concentration number: 140‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Patients undergoing coronary angiography or angioplasty ; MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: to demonstrate the superiority of an experimental hydration “CARBONATI” (154 mEq/l in dextrose and water received 3 ml/kg for 1h before contrast exposure followed by an infusion of 1 ml/kg/h for 6h after the procedure) versus isotonic saline solution (standard hydratation) received 0,5 ml/kg/h sodium chloride intravenously for 12 h before and after the procedure, in patients with high risk of acute heart failure ad high risk to develop contrast induced nephropaty, who undergoing coronary angiography, followed or not by coronary revascularization. Primary end point(s): Incidence of contrast‐induced nephropaty defined as an increases in serum creatinine concentration either at least 0.5 mg/dl or 25% from baseline within 48 hours after coronary angiography. Secondary Objective: NA Timepoint(s) of evaluation of this end point: 48h after procedure SECONDARY OUTCOME: Secondary end point(s): Incidence of acute heart failure (pulmunary edema) Timepoint(s) of evaluation of this end point: In 24h from the beginning of hydration INCLUSION CRITERIA: • Consecutive patients undergoing coronary angiography, followed or not by coronary revascularization, at Cath Lab of U.O. of Universitary Cardiology “AOU Maggiore della Carità”, Novara. • An estimated glomerular filtration rate (GFR) of 60 mL/min or less (calculated by applying the Cockroft‐Gault formula) before undergoing coronary angiography. • An estimated ejection fraction<40% (transthoracic echocardiogram). • Severe mitro‐aortic valve disease estimated by transthoracic echocardiogram also in the presence of an ejection fraction >40%. • Recent episode af acute pulmonary edema. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100