Actively Recruiting

Age: 18Years +
All Genders
NCT06973902

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here