Actively Recruiting
The Predictive Value of Dobutamine Echo-stress in the Clinical Response to CCM Therapy in Advanced HF
Led by Quovadis Associazione · Updated on 2025-07-29
120
Participants Needed
13
Research Sites
181 weeks
Total Duration
On this page
Sponsors
Q
Quovadis Associazione
Lead Sponsor
I
Impulse Dynamics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Predictive Value of Dobutamine Echo-stress in the Clinical Response to CCM Therapy in Advanced HF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to understand and sign informed consent
- Symptomatic heart failure despite optimal medical therapy
- Reduced left ventricular systolic function with ejection fraction less than 50%
- Positively evaluated for CCM implantation per ESC 2021 guidelines and CE mark approval
- At least one hospitalization, emergency department visit, or day hospital stay over 4 hours for heart failure in the year before implantation
You will not qualify if you...
- Life expectancy less than 1 year due to non-cardiac conditions
- Contraindications to CCM implantation, including lack of usable vascular access, active infections, severe coagulopathies, or mechanical tricuspid valve
- Contraindications to pharmacologic stress echocardiography, such as ongoing heart failure, acute myocardial infarction, acute inflammatory heart conditions, critical aortic valve stenosis, severe left ventricular outflow obstruction, dissecting aortic aneurysm, uncontrolled severe arrhythmias, hypersensitivity to dobutamine, or intraventricular thrombi
AI-Screening
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Trial Site Locations
Total: 13 locations
1
PO Anastasia Guerriero, Marcianise (CE), UOC Cardiologia
Marcianise, Campania, Italy
Actively Recruiting
2
Clinica Montevergine, Mercogliano (AV), Laboratorio di Elettrofisiologia
Mercogliano, Campania, Italy
Actively Recruiting
3
UOC Cardiologia, Osp. San Rocco, Sessa Aurunca (CE), ASL Caserta
Sessa Aurunca, Campania, Italy
Actively Recruiting
4
Policlinico S.Orsola, UO Cardiologia
Bologna, Emilia-Romagna, Italy
Actively Recruiting
5
OSPEDALE CASTELLI, UO Cardiologia
Anzio, Lazio, Italy
Actively Recruiting
6
Elettrofisiologia e Aritmologia, ASST FBF Sacco
Milan, Lombardy, Italy
Actively Recruiting
7
Fondazione Giglio, Cefalù (PA), UOC Cardiologia
Cefalù, Sicily, Italy
Actively Recruiting
8
Osp. Generale Provinciale Mazzoni, UO Cardiologia
Ascoli Piceno, The Marches, Italy
Active, Not Recruiting
9
UOC Cardiologia, Osp. Di Mirano, ULSS 3 Serenissima
Mirano, Veneto, Italy
Actively Recruiting
10
UOC Cardiologia, Osp. Di Piove di Sacco (PD), ULSS 6 Euganea
Piove di Sacco, Veneto, Italy
Actively Recruiting
11
UOC Cardiologia, Osp. S.Bortolo, Vicenza, ULSS 8 Berica
Vicenza, Veneto, Italy
Actively Recruiting
12
UOC Cardiologia con UTIC, Osp. Di Venere
Bari, Italy, 70131
Actively Recruiting
13
UO Cardiologia, S. Maria della Misericordia Hospital, ULSS5 Polesana
Rovigo, Italy, 45100
Actively Recruiting
Research Team
F
Franco Noventa, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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