Hospital Lariboisière
Paris, 75010, France
NCT Number: NCT05272878
The patients discharged from intensive care units (ICU) have a high incidence of cardiovascular events and mortality rate during the year following ICU discharge. Among patients admitted to the ICU, patients with acute kidney injury (AKI) display high risk of such events. The investigators furthermore demonstrated that AKI could induce remote cardio-vascular injury and fibrosis, which may be involved in the poor prognosis of AKI. Strategies that may prevent the cardiovascular consequences of AKI in most severe patients (i.e. post-AKI ICU survivors) may therefore improve long term outcomes.
AKI has been associated with activation of the renin-angiotensin-aldosterone system (RAAS). Activation of the RAAS has been further associated with long-term health consequences especially with cardiovascular damages. Potential protective effects of RAASi following acute injury have been reported in observational studies. With this randomized controlled trial, the investigators aim at investigating the impact of treatment with RAAS inhibitors after AKI on cardiovascular and kidney outcomes.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Paris, 75010, France
Phase III study Prospective, multicenter, superiority, double-blind, randomized controlled study with two arms (1:1).
Biological collection
A plasma and urine collected as part of the study will be stored in a biological sample collection at inclusion and at the end of the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IRBESARTAN will be introduced at 150 mg orally one daily, with a progressive increase to 300 mg a day, at 7 days or 2 months follow-up visit.Treatment will be continued for 12 months, unless a side effect would occur.
Placebo will be introduced at 150 mg orally one daily, with a progressive increase to 300 mg a day, at 7 days or 2 months follow-up visit.Treatment will be continued for 12 months, unless a side effect would occur.
Time frame: Within the year after randomization
cardiovascular events will be defined as: acute heart failure, stroke, acute coronary syndrome
Time frame: one year after ICU discharge
kidney disease defined as eGFR <60 ml/min/1.73m2
Time frame: one year after ICU discharge
Time frame: One year after randomization
Time frame: One year after randomization
Time frame: within one year after randomization
Acute kidney injury according to the KDIGO criteria
Time frame: within one year after randomization
Time frame: within one year after randomization
Assistance Publique - Hôpitaux de Paris
Other
Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU "START-or-NOT Trial". A Prospective, Randomized, Double Blinded, Multicenter Study
Acronym: START-or-NOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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