Angiotensin-converting-enzyme (ACE) Inhibitors in Hemodialysis

Launched by MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH · Sep 25, 2009

Keywords

ClinConnect Summary

Angiotensin converting enzyme (ACE) inhibitors have the broader effect of any drug in cardiovascular medicine, reducing the risk of death, myocardial infarction, stroke, diabetes, and renal impairment.A recent meta-analysis of 33,500 patients included in six randomized clinical trials and a pooled analysis of the Heart Outcomes Prevention Evaluation (HOPE), the European Trial on Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease (EUROPA, and the Prevention of Events with Angiotensin-Converting-Enzyme Inhibition (PEACE) trials showed that ACE inhibitors reduce mor...

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Eligibility criteria

• Inclusion criteria:
• • Men and women \>18 years of age who are on chronic renal replacement treatment since at least 6 months with two or three haemodialysis sessions per week.
• • Hypertension (pre-dialysis systolic and/or diastolic BP \>140/90 mmHg or post-dialysis systolic and/or diastolic BP \>130/80 mmHg or ongoing antihypertensive therapy).
• • and/or
• • LVH defined by a cardiac mass index \>130 g/m2 for men and 100 g/m2 for women (17) within three months of enrolment.
• • Written informed consent.
• Exclusion criteria:
• • Specific indication (such as heart failure) or contraindication (such as hypersensitivity) to ACE inhibitor therapy.
• • Any concomitant medication with ACE inhibitors and angiotensin II receptor antagonists
• • Hyperkalemia (serum potassium \>6 mEq/L) despite optimal control of metabolic acidosis and blood glucose (in diabetics) in patient with less then three dialysis sessions per week.
• • Symptomatic chronic or intradialytic hypotension.
• • Arrhythmias that in the Investigator judgement might be worsened by hyperkalemia (such as sinus bradycardia, delayed atrio-ventricular conduction, atrio-ventricular blocks).
• • CV events (stroke, acute myocardial infarction or other acute coronary syndromes) over the last three months.
• • Uncontrolled hyper- or hypo-thyroidism.
• • Active systemic disease, malignancies and any clinical condition associated with a life-expectancy of less than 2 years.
• • Drug or alcohol abuse, psychiatric disorders and inability to understand the potential risks or benefits of the study.
• • Pregnancy, lactation or child bearing potential and ineffective contraception.