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NCT06973902: PREDICT-CCM

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

Recruiting now Last updated 29 July 2025
What this trial tests

trial testing Cardiac Contractility Modulation (CCM) implant in Symptomatic Congestive Heart Failure in 120 participants. Currently enrolling.

Timeline
10 July 2025
Primary endpoint
31 December 2028
31 December 2028

Quick facts

Lead sponsorQuovadis Associazione
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment120
Start date10 July 2025
Primary completion31 December 2028
Estimated completion31 December 2028
Sites13 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Quovadis Associazione — full company profile →

Who can join

18 and older, any sex, with Symptomatic Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Quovadis Associazione trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06973902.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing