RecruitingNCT06973902

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

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


Sponsor

Quovadis Associazione

Enrollment

120 participants

Start Date

Jul 10, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a stress echocardiogram (an ultrasound of the heart during a medication-induced stress test) can predict how well people with advanced heart failure will respond to a special implanted device called a cardiac contractility modulator (CCM), which delivers electrical pulses to strengthen heart contractions. **You may be eligible if...** - You are 18 or older with heart failure symptoms despite optimal medical treatment - Your heart's pumping function is reduced (ejection fraction below 50%) - Your doctor has already recommended a CCM device for you - You have been hospitalized or visited an emergency department for heart failure in the past year **You may NOT be eligible if...** - You are unable to give informed consent - You have contraindications to the CCM device or the stress test Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardiac Contractility Modulation (CCM) implant

Subjects participating in the study carry or will carry the Cardiac Contractility Modulation (CCM) medical device "OPTIMIZER Smart Mini" by Impulse Dynamics (USA). It is indicated for use in patients over 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction, despite appropriate medical treatment. The OPTIMIZER Smart Mini Implantable Pulse Generator is a programmable device with an internal battery and telemetry functions. The OPTIMIZER Smart Mini is connected to two or three implantable leads, two of which are implanted in the right ventricle and one, optionally, in the right atrium.


Locations(13)

PO Anastasia Guerriero, Marcianise (CE), UOC Cardiologia

Marcianise, Campania, Italy

Clinica Montevergine, Mercogliano (AV), Laboratorio di Elettrofisiologia

Mercogliano, Campania, Italy

UOC Cardiologia, Osp. San Rocco, Sessa Aurunca (CE), ASL Caserta

Sessa Aurunca, Campania, Italy

Policlinico S.Orsola, UO Cardiologia

Bologna, Emilia-Romagna, Italy

OSPEDALE CASTELLI, UO Cardiologia

Anzio, Lazio, Italy

Elettrofisiologia e Aritmologia, ASST FBF Sacco

Milan, Lombardy, Italy

Fondazione Giglio, Cefalù (PA), UOC Cardiologia

Cefalù, Sicily, Italy

Osp. Generale Provinciale Mazzoni, UO Cardiologia

Ascoli Piceno, The Marches, Italy

UOC Cardiologia, Osp. Di Mirano, ULSS 3 Serenissima

Mirano, Veneto, Italy

UOC Cardiologia, Osp. Di Piove di Sacco (PD), ULSS 6 Euganea

Piove di Sacco, Veneto, Italy

UOC Cardiologia, Osp. S.Bortolo, Vicenza, ULSS 8 Berica

Vicenza, Veneto, Italy

UOC Cardiologia con UTIC, Osp. Di Venere

Bari, Italy

UO Cardiologia, S. Maria della Misericordia Hospital, ULSS5 Polesana

Rovigo, Italy

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NCT06973902