Low-dose dobutamine stress echo to predict benefit from cardiac contractility modulation in advanced heart failure

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

This project tests whether a low-dose dobutamine stress echocardiogram can help predict which adults with symptomatic systolic heart failure will improve after receiving a Cardiac Contractility Modulation (CCM) implant.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Quovadis Associazione (Academic / other)
• Drugs / interventions: radiation
• Locations: 13 sites (Marcianise, Campania and 12 other locations)
• Trial ID: NCT06973902 on ClinicalTrials.gov

What this trial studies

This is an observational cohort study with both retrospective and prospective components that uses preimplantation low-dose dobutamine stress echocardiography to stratify patients considered for CCM therapy. Participants are adults with symptomatic heart failure and reduced left ventricular systolic function despite optimal medical therapy who are eligible for a CCM implant. The study tracks clinical response at 12 months (NYHA class reduction ≥1), changes in hospital and emergency department use compared with the prior year, and quality-of-life changes measured by the Minnesota Living with Heart Failure questionnaire. Data come from several cardiology centers in the Campania region of Italy and include both clinical and instrumental follow-up.

Who should consider this trial

Good fit: Adults (≥18 years) with symptomatic systolic heart failure (EF <50%) despite optimal medical therapy who have been judged eligible for a CCM implant and who had at least one hospitalization or ED/day-hospital access in the prior year are the intended candidates.

Not a fit: Patients with life expectancy under one year from non-cardiac comorbidities, those with contraindications to CCM implantation, or those lacking left ventricular contractile reserve on dobutamine stress echo are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the approach could help clinicians identify which patients are most likely to gain symptom relief and reduced hospital use from a CCM implant, improving patient selection and avoiding unnecessary procedures.

How similar studies have performed: Prior randomized and nonrandomized studies of CCM devices have shown symptomatic and quality-of-life improvements in selected patients, but using low-dose dobutamine stress echocardiography specifically to predict CCM response is less well established.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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).

Where this trial is running

Marcianise, Campania and 12 other locations

• PO Anastasia Guerriero, Marcianise (CE), UOC Cardiologia — Marcianise, Campania, Italy (Recruiting)
• Clinica Montevergine, Mercogliano (AV), Laboratorio di Elettrofisiologia — Mercogliano, Campania, Italy (Recruiting)
• UOC Cardiologia, Osp. San Rocco, Sessa Aurunca (CE), ASL Caserta — Sessa Aurunca, Campania, Italy (Recruiting)
• Policlinico S.Orsola, UO Cardiologia — Bologna, Emilia-Romagna, Italy (Recruiting)
• OSPEDALE CASTELLI, UO Cardiologia — Anzio, Lazio, Italy (Recruiting)
• Elettrofisiologia e Aritmologia, ASST FBF Sacco — Milan, Lombardy, Italy (Recruiting)
• Fondazione Giglio, Cefalù (PA), UOC Cardiologia — Cefalù, Sicily, Italy (Recruiting)
• Osp. Generale Provinciale Mazzoni, UO Cardiologia — Ascoli Piceno, The Marches, Italy (Active_not_recruiting)
• UOC Cardiologia, Osp. Di Mirano, ULSS 3 Serenissima — Mirano, Veneto, Italy (Recruiting)
• UOC Cardiologia, Osp. Di Piove di Sacco (PD), ULSS 6 Euganea — Piove di Sacco, Veneto, Italy (Recruiting)
• UOC Cardiologia, Osp. S.Bortolo, Vicenza, ULSS 8 Berica — Vicenza, Veneto, Italy (Recruiting)
• UOC Cardiologia con UTIC, Osp. Di Venere — Bari, Italy (Recruiting)
• UO Cardiologia, S. Maria della Misericordia Hospital, ULSS5 Polesana — Rovigo, Italy (Recruiting)

Study contacts

• Study coordinator: Franco Noventa, MD

Conditions Symptomatic Congestive Heart Failure; Heart failure; systolic left ventricular dysfunction; low-dose dobutamine stress echocardiography; Cardiac Contractility Modulation