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April 25, 2026Journal of Clinical Medicine0 citationsOpen Access

Rationale and Design of the PREDICT-CCM Study: Predictive Value of Dobutamine Stress Echocardiography for Clinical Response to Cardiac Contractility Modulation Therapy in a Multicenter Italian Cohort

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FZFrancesco ZanonCUCarlo UranVBVincenzo Bonfantino

Key Result

Dobutamine stress echocardiography will be evaluated in 120 heart failure patients to determine if left ventricular contractile reserve predicts response to cardiac contractility modulation.

Key Points

  • The study aims to assess the predictive value of dobutamine stress echocardiography for clinical outcomes in heart failure patients receiving CCM therapy.
  • Multicenter, non-profit observational cohort study in Italy with retrospective and prospective enrollment.
  • Primary endpoint is clinical response at 12 months, defined as a ≥1-class reduction in NYHA class.
  • Secondary endpoints include HF-related hospitalizations, changes in quality of life, and NT-proBNP level changes.
  • Estimated sample size is 120 patients, assuming a 70% clinical response rate at 12 months.
  • Outcomes will be categorized by left ventricular end systolic volume reductions of ≥ 15% and < 15%.
  • New criteria for patient selection and outcome assessment in CCM therapy may emerge.

Structured PICO

Does pre-implant low-dose dobutamine stress echocardiography predict clinical response to Cardiac Contractility Modulation therapy in patients with symptomatic heart failure?

P
Population
Estimated 120 patients with symptomatic heart failure despite Optimal Medical Therapy (OMT)
I
Intervention
Cardiac Contractility Modulation (CCM) therapy with pre-implant low-dose dobutamine stress echocardiography (LDDSE)
O
Outcome
Proportion of subjects with a clinical response to CCM at 12 months, defined as a ≥1-class reduction in NYHA classpatient reported

The PREDICT-CCM study will evaluate whether left ventricular contractile reserve assessed by low-dose dobutamine stress echocardiography can predict clinical response to Cardiac Contractility Modulation therapy in heart failure patients.

Abstract

Background/Objectives: Heart failure (HF) is associated with substantial morbidity, impaired quality of life (QOL), and reduced functional capacity. In selected patients with symptomatic HF despite Optimal Medical Therapy (OMT), Cardiac Contractility Modulation (CCM) may be a therapeutic option. Identifying patients most likely to benefit from CCM remains an unmet need. The Predict-CCM study aims to evaluate long-term clinical and objective outcomes after CCM therapy and to assess the predictive value of pre-implant low-dose dobutamine stress echocardiography (LDDSE). Methods and Results: Predict-CCM is an independent, non-profit, multicenter, observational cohort study conducted in Italy, with both retrospective and prospective enrollment. The primary endpoint is the proportion of subjects with a clinical response to CCM at 12 months, defined as a ≥1-class reduction in NYHA class. Secondary clinical endpoints include reductions in HF-related hospitalizations, changes in QOL assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and changes in NT-proBNP levels from baseline to follow-up. Outcomes will be evaluated in the overall cohort and in two subcohorts stratified by pre-implant LDDSE response: (1) reduction in left ventricular end systolic volume (LVESV) ≥ 15% (DeltaLVESV ≥ 15%); and (2) reduction in LVESV < 15% (DeltaLVESV < 15%). Assuming a 70% clinical response rate at 12 months, the estimated sample size is 120 patients. The study was approved by the Ethics Committee in March 2025. Enrollment will continue for 2 years, with a 12-month follow-up period after implant for each subject. Conclusions: This study may provide new criteria for patient selection and outcome assessment in CCM therapy. Left ventricular contractile reserve assessed by stress echocardiography may be a promising predictor of response.

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Cite This Study

Zanon et al. (2026) studied this question. Dobutamine stress echocardiography will be evaluated in 120 heart failure patients to determine if left ventricular contractile reserve predicts response to cardiac contractility modulation.

synapsesocial.com/papers/69ec5ac988ba6daa22dac5b7https://doi.org/10.3390/jcm15093223
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