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

A PROSPECTIVE, RANDOMIZED, OPEN LABEL, BLINDED END-POINT (PROBE) TRIAL TO EVALUATE WHETHER, AT COMPARABLE BLOOD PRESSURE CONTROL, ACE INHIBITOR THERAPY MORE EFFECTIVELY THAN NON RAS INHIBITOR THERAPY REDUCES CARDIOVASCULAR MORBIDITY AND MORTALITY IN CHRONIC DIALYSIS PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY AND/OR ARTERIAL HYPERTENSION (ARCADIA Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003529-17-IT

Enrollment

266

Registered

2008-10-17

Start date

2008-11-17

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End stage renal disease MedDRA version: 14.1 Level: PT Classification code 10029151 Term: Nephropathy System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: TRIATEC Pharmaceutical Form: Tablet INN or Proposed INN: Ramipril Concentration unit: mg milligram(s) Concentration number: 2.5- Trade Name: TRIATEC Pharmaceutical Form: Tablet INN or Pro

Eligibility

Sex/Gender

All

Inclusion 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. 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess whether, at comparable BP control, ACE inhibitor as compared to non-RAS inhibitor therapy reduces the incidence of a combined end-point of CV death (including sudden cardiac death and cardiac arrest resuscitation) and myocardial infarction or non-fatal stroke.;Secondary Objective: - To compare the incidence of the single components of the combined end-point, of myocardial or peripheral revascularizations, new onset of atrial fibrillation in one of its three forms (paroxysmal, persistent and permanent) or recurrence of the arrhythmia in patients who experienced paroxysmal or persistent atrial fibrillation previously, hospitalizations for chronic heart failure and thrombosis of the artero-venous fistula. - To evaluate whether ACE inhibitors limit progression or achieve regression of LVH and ameliorate some of the components of the metabolic syndrome and whether these effects correlates with CV outcomes. - To compare the cost/effectiveness of the two treatments.;Primary end point(s): The main outcome variable will be a combined end-point of cardiovascular death (including sudden death and cardiac arrest resuscitation) and myocardial infarction or non-fatal stroke.;Timepoint(s) of evaluation of this end point: At randomization and then every three months.	—

Measure

Time frame

Main Objective: - To assess whether, at comparable BP control, ACE inhibitor as compared to non-RAS inhibitor therapy reduces the incidence of a combined end-point of CV death (including sudden cardiac death and cardiac arrest resuscitation) and myocardial infarction or non-fatal stroke.;Secondary Objective: - To compare the incidence of the single components of the combined end-point, of myocardial or peripheral revascularizations, new onset of atrial fibrillation in one of its three forms (paroxysmal, persistent and permanent) or recurrence of the arrhythmia in patients who experienced paroxysmal or persistent atrial fibrillation previously, hospitalizations for chronic heart failure and thrombosis of the artero-venous fistula. - To evaluate whether ACE inhibitors limit progression or achieve regression of LVH and ameliorate some of the components of the metabolic syndrome and whether these effects correlates with CV outcomes. - To compare the cost/effectiveness of the two treatments.;Primary end point(s): The main outcome variable will be a combined end-point of cardiovascular death (including sudden death and cardiac arrest resuscitation) and myocardial infarction or non-fatal stroke.;Timepoint(s) of evaluation of this end point: At randomization and then every three months.

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Secondary

Measure	Time frame
Secondary end point(s): - Incidence of the single components of the combined end-point, of myocardial or peripheral revascularizations, new onset of atrial fibrillation2 in one of its three forms (paroxysmal, persistent and permanent) or recurrence of the arrhythmia in patients who experienced paroxysmal or persistent atrial fibrillation previously, hospitalizations for chronic heart failure3 and thrombosis of the artero-venous fistula.;Timepoint(s) of evaluation of this end point: At randomization, 12 and 24 months.	—

Measure

Time frame

Secondary end point(s): - Incidence of the single components of the combined end-point, of myocardial or peripheral revascularizations, new onset of atrial fibrillation2 in one of its three forms (paroxysmal, persistent and permanent) or recurrence of the arrhythmia in patients who experienced paroxysmal or persistent atrial fibrillation previously, hospitalizations for chronic heart failure3 and thrombosis of the artero-venous fistula.;Timepoint(s) of evaluation of this end point: At randomization, 12 and 24 months.

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Countries

Italy

Contacts

Public ContactLab. att. regolatorie studi clinici

Istituto di Ricerche Farmacologiche Mario Negri

paola.boccardo@marionegri.it035 45351

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026