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

Launched by QUOVADIS ASSOCIAZIONE · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a treatment called Cardiac Contractility Modulation (CCM) works for people with symptomatic congestive heart failure (HF) who have not seen enough improvement with standard medications. The researchers want to find out how many patients feel better after 12 months of receiving CCM therapy, how many have fewer hospital visits, and if their quality of life improves. They will also look at changes in walking distance and specific heart-related blood markers over the study period.

To be eligible for this trial, participants must be at least 18 years old and have heart failure that is not well controlled with medication. They should have a weakened heart function (with an ejection fraction of less than 50%) and have had at least one hospital visit related to their heart condition in the year before joining the study. Participants will receive CCM as part of their regular care and will be monitored for 12 months to see how well they respond to the treatment. It’s important to note that this trial is currently active but not recruiting new participants.

Gender

ALL

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).