The Laboratory of Cardiovascular Clinical Pharmacology designs and coordinates controlled clinical studies to characterize the phenotype of patients with cardiovascular diseases and to collect blood and tissue samples in a certified biological bank.
The primary objective of the Laboratory, using the biobank, is to identify "biomarkers" circulating in the blood, which help to diagnose cardiovascular diseases and individualize treatment.
Circulating markers in patients with head trauma
The CREACTIVE study (Collaborative REsearch on ACute Traumatic brain Injury in intensiVe care medicine in Europe) is an international study funded by the European Commission, FP7 – HEALTH – 2013-INNOVATION-1. The study is coordinated by the Mario Negri Institute for Pharmacological Research through GiViTi (Italian Group for the Evaluation of Interventions in Intensive Care). CREACTIVE is a longitudinal prospective observational study aimed at obtaining information on the effectiveness of treatments normally used in patients with severe and moderate head injury. It has an expected duration of 60 months and will include about 8.000 patients in 7 European countries, the largest epidemiological study on serious and moderate head trauma ever made in the world. Specifically, the Laboratory of Cardiovascular Clinical Pharmacology manages the bio-humoral sub-project, which aims to identify circulating markers of prognosis and treatment efficacy.
Diabetes mellitus and cardiac function
a. Effects of DPP-4 inhibitor on myocardial dysfunction DYDA-2: a multicentre, double blind, placebo controlled phase III trial. The objective is to evaluate the effect of linagliptin 5 mg / day compared to placebo on the systolic function of the left ventricle (VS) in patients with type 2 diabetes mellitus, with concentric VS geometry and asymptomatic VS systolic dysfunction. b. Effects of insulin in elderly patients with heart failure Heart failure (HF) and type 2 diabetes mellitus (T2DM) represent two conditions with a high impact on public health. The combination of T2DM and HF is frequent and optimal blood glucose control is a problem since hypoglycemic drugs can increase the cardiovascular risk. The risk / benefit ratio of insulin, prescribed in 30% of patients, is controversial particularly in elderly and frail individuals. A clinical study called Insulin-HF aims to compare the risk / benefit of two therapeutic strategies: standard therapy + insulin vs. standard insulin-free therapy in terms of biohumoral and clinical endpoints, in elderly patients with HF and T2DM.
New therapeutic approaches for critically ill patients: septic shock
The primary objective of the multicentre ALBIOSS-BALANCED trial is to evaluate, in patients with septic shock, whether (1) the administration of albumin in addition to crystalloids, compared to the use of crystalloid alone, reduces mortality at 90 days; (2) the use of balanced crystalloid solutions reduces 90-day mortality or the incidence of acute renal failure, compared to the use of Physiological Solution. The present study also aims to create a biological bank (of plasma and urine samples) to study circulating and urinary markers that can aid in diagnosis and prognosis, and can clarify the response to treatments applied during septic shock.
Long-term therapy after acute myocardial infarction
Beta-blocking drugs have been used in clinical practice for decades in the treatment of acute myocardial infarction although there is no evidence of their beneficial effect when used chronically in patients without left ventricular dysfunction. REBOOT, a pragmatic, multicentre, prospective, randomized study, aims to evaluate the benefits of prolonged beta-blocker therapy in patients discharged after acute myocardial infarction, with preserved ventricular function. The research project is promoted by the "Centro de Investigaciones Cardiovasculares, CNIC" of Madrid and our Department is responsible for the scientific and organizational coordination of the Italian Cardiology network.
Treatment of familial brain angiomas
Treat-CCM (TREATing Cerebral Cavernous Malformations) is a randomized, open-label, controlled, multicenter study (PROBE design, a prospective Randomized Open Trial with Blinded Evaluation of Outcomes). The study includes patients with familial CCM who present the eligibility criteria. Patients will be randomized with a proportion of 2: 1 (propranolol: standard treatment). The reading of the MRI exams will be centralized as well as the assessment of adverse events. The primary objective of this study is to analyse whether treatment with propranolol is able to reduce the severity of cerebrovascular lesions and clinical events in patients with familial CCM.
International Consensus on Cardiopulmonary Resuscitation.