Study to assess efficacy of angiotensin converting enzyme inhibitors on mortality and cardiovascular morbidity in patients on chronic hemodialysis, with ventricular hypertrophy and / or hypertensio

Phase 1

• Conditions: End stage renal disease; MedDRA version: 14.1Level: PTClassification code 10029151Term: NephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2008-003529-17-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-17
• Study Completion: 2016-04-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 269

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.
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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 136

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified