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The Predictive Value of Dobutamine Echo-stress in the Clinical Response to CCM Therapy in Advanced HF

Recruitingn/aAges 18 Years - anyAllQuovadis Associazione
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In plain words

What the trial is, and whether it could suit you

The goal of this observational cohort study, which is both retrospective and prospective, is to evaluate the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) treatment in adult subjects suffering from symptomatic heart failure (HF) due to systolic left ventricular dysfunction, despite adequate medical therapy. Based on the response to stress echocardiography with preimplantation low-dose Dobutamine, the main questions it aims to answer are: * What is the proportion of subjects who experience a clinical response to CCM therapy at 12 months (NYHA reduction ≥ 1 class)? * There was a reduction in the number of hospitalizations, visits to the Emergency Department, and access to day hospital facilities for more than 4 hours compared to the year before the study (e.g., by intravenous infusion of cardiac inotropic drugs)? * What is the estimated change in t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subject of both sexes with age ≥ 18 years, * Ability to understand and sign informed consent to participate in the study and consent to process sensitive personal data. * Carrier of symptomatic heart failure, despite optimal medical therapy (OMT), * Reduced left ventricular systolic function (E.F. \<50%), * It was positively evaluated for implanting a system for cardiac contractility modulation (CCM) (according to the European Society of Cardiology 2021 Guidelines on heart failure and the provisions of the C.E. mark approval)13. * Have presented at least one hospitalization, access to the Emergency Department, or access to day hospital facilities for more than 4 hours (e.g., by intravenous infusion of cardiac inotropic drugs) in the year before implantation Exclusion Criteria: * Life expectancy \< 1 year due to non-cardiac comorbidities that reduce prognosis, * Presence of contraindications to the CCM implantation procedure (absence of vascular access usable for CCM implantation, active infectious processes, active severe coagulopathies, presence of mechanical tricuspid valve), * Contraindications to the performance of the echocardiographic test under pharmacological stress (heart failure in progress, myocardial infarction in the acute phase, acute inflammatory processes of the heart muscle and/or pericardium, critical aortic valve stenosis and severe obstructions to left ventricular outflow, dissecting aneurysm of the aorta, severe arrhythmias not controlled by therapy, known hypersensitivity to the drug, intraventricular thrombi).
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What it tests

  • Cardiac Contractility Modulation (CCM) implant
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Where

13 sites
PO Anastasia Guerriero, Marcianise (CE), UOC Cardiologia
Marcianise, Italy
Clinica Montevergine, Mercogliano (AV), Laboratorio di Elettrofisiologia
Mercogliano, Italy
UOC Cardiologia, Osp. San Rocco, Sessa Aurunca (CE), ASL Caserta
Sessa Aurunca, Italy
Policlinico S.Orsola, UO Cardiologia
Bologna, Italy
OSPEDALE CASTELLI, UO Cardiologia
Anzio, Italy
Elettrofisiologia e Aritmologia, ASST FBF Sacco
Milan, Italy
Fondazione Giglio, Cefalù (PA), UOC Cardiologia
Cefalù, Italy
Osp. Generale Provinciale Mazzoni, UO Cardiologia
Ascoli Piceno, Italy

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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