Status:
COMPLETED
Angiotensin-converting-enzyme (ACE) Inhibitors in Hemodialysis
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Conditions:
Left Ventricular Hypertrophy
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Background: Angiotensin-converting-enzyme (ACE) inhibitors have a specific cardioprotective effect and, compared to treatment not directly interfering with the renin-angiotensin-system (RAS), signific...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT00985322
Start Date
May 1 2009
End Date
April 1 2016
Last Update
January 11 2021
Active Locations (29)
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1
Policlinico San Pietro
Ponte San Pietro, Bergamo, Italy
2
Ospedale "Treviglio-Caravaggio"
Treviglio, Bergamo, Italy
3
Hospital of Montichiari
Montichiari, Brescia, Italy
4
Presidio Ospedaliero Acireale
Acireale, Catania, Italy