Status:
RECRUITING
The Predictive Value of Dobutamine Echo-stress in the Clinical Response to CCM Therapy in Advanced HF
Lead Sponsor:
Quovadis Associazione
Collaborating Sponsors:
Impulse Dynamics
Conditions:
Symptomatic Congestive Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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) trea...
Detailed Description
-Introductory summary When no other therapeutic options are available, CCM can be a helpful complement to treating heart failure, improving quality of life, and prolonging survival. Still, the high co...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06973902
Start Date
July 10 2025
End Date
December 31 2028
Last Update
July 29 2025
Active Locations (13)
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1
PO Anastasia Guerriero, Marcianise (CE), UOC Cardiologia
Marcianise, Campania, Italy
2
Clinica Montevergine, Mercogliano (AV), Laboratorio di Elettrofisiologia
Mercogliano, Campania, Italy
3
UOC Cardiologia, Osp. San Rocco, Sessa Aurunca (CE), ASL Caserta
Sessa Aurunca, Campania, Italy
4
Policlinico S.Orsola, UO Cardiologia
Bologna, Emilia-Romagna, Italy