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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Franco Noventa, MD
• Email: franco.noventa@quovadis-ass.it
• Phone: +39 049715373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.