Advanced Heart Failure: The Predictive Value of Dobutamine Echo-stress in the Clinical Response to Cardiac Contractility Modulation Therapy (CCM)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Observational
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) 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 the quality-of-life score using the Quality of Life Questionnaire with Heart Failure - Minnesota (MLHFQ) between baseline and the end of follow-up? * What is the change in walking distance between baseline and the end of the follow-up in the walk test (6MWT) (optional)? * What is the difference in NT-proBNP levels between baseline and the end of follow-up? Participants are already receiving CCM support as part of their regular medical care for heart failure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
OSPEDALE CASTELLI, UO Cardiologia
RECRUITING
Anzio
Osp. Generale Provinciale Mazzoni, UO Cardiologia
ACTIVE_NOT_RECRUITING
Ascoli Piceno
UOC Cardiologia con UTIC, Osp. Di Venere
RECRUITING
Bari
Policlinico S.Orsola, UO Cardiologia
RECRUITING
Bologna
Fondazione Giglio, Cefalù (PA), UOC Cardiologia
RECRUITING
Cefalù
PO Anastasia Guerriero, Marcianise (CE), UOC Cardiologia
RECRUITING
Marcianise
Clinica Montevergine, Mercogliano (AV), Laboratorio di Elettrofisiologia
RECRUITING
Mercogliano
Elettrofisiologia e Aritmologia, ASST FBF Sacco
RECRUITING
Milan
UOC Cardiologia, Osp. Di Mirano, ULSS 3 Serenissima
RECRUITING
Mirano
UOC Cardiologia, Osp. Di Piove di Sacco (PD), ULSS 6 Euganea
RECRUITING
Piove Di Sacco
UO Cardiologia, S. Maria della Misericordia Hospital, ULSS5 Polesana
RECRUITING
Rovigo
UOC Cardiologia, Osp. San Rocco, Sessa Aurunca (CE), ASL Caserta
RECRUITING
Sessa Aurunca
UOC Cardiologia, Osp. S.Bortolo, Vicenza, ULSS 8 Berica
RECRUITING
Vicenza
Contact Information
Primary
Franco Noventa, MD
franco.noventa@quovadis-ass.it
+39 049715373
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
DeltaESV>=15%
Subjects showing a reduction of 15% or more in LVESV through pre-implant low-dose dobutamine echocardiography stress testing
DeltaESV<15%
Subjects showing a reduction of less than 15% in LVESV through pre-implant low-dose dobutamine echocardiography stress testing
Related Therapeutic Areas
Sponsors
Leads: Quovadis Associazione
Collaborators: Impulse Dynamics

This content was sourced from clinicaltrials.gov