Studies a heart device's effect on heart failure medicines
Observes how a heart device affects heart failure medicine use in adults.
Plain-language title generated from the registry record
Registry title: CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
Key facts
- Where
- Naples and Rome, ItalySee the 2 sites
Where in Italy
- AO dei Colli - O.MonaldiNaples, ItalyTaking people
- Gemelli University HospitalRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Impulse Dynamics
- Trial code
- NCT06580392
- Record updated
- 11 July 2025
- Original description
The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.Read full original descriptionShow less
Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure
The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.
Inclusion: Adults (≥18 years) diagnosed with symptomatic heart failure; Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%; Historical LVEF assessed up to 6 months prior to consent by any modality can be used if available; Patients can have an active concomitant CRT device already - implanted provided the following criteria:; CRT device has been implanted >1 year; Patients are functional class NYHA III-IV.
Exclusion: Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications; Patients with a concomitant CRT device that has already been implanted and deemed to be a responder; Patients with class I indication for a concomitant CRT device; Patients with contraindications to CCM therapy or unable to undergo implantation; Patients with significant comorbidities or conditions that may interfere with the study assessments; Severe stenotic valve disease; eGFR <15; Patients with a QMS score >5.