Ireland
--:--IST
Recruiting Observational

CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)

NCT06580392 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-02-01
Last updated
2025-07-11

Condition(s) studied

Heart Failure

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adults (≥18 years) diagnosed with symptomatic heart failure 2. 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 3. 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 Criteria: 1. Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications. 2. Patients with a QMS score \>5 3. eGFR \<15 4. Patients with a concomitant CRT device that has already been implanted and deemed to be a responder 5. Patients with class I indication for a concomitant CRT device 6. Patients with significant comorbidities or conditions that may interfere with the study assessments 7. Patients with contraindications to CCM therapy or unable to undergo implantation 8. Severe stenotic valve disease

Primary outcome measure(s)

  • Change in Quad Medication Score — 6 month
    Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant

Trial sites (2)

FacilityCityRegionStatus
Gemelli University Hospital Rome Italy Recruiting
AO dei Colli - O.Monaldi Naples Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06580392 on ClinicalTrials.gov ↗ ← All trials in Italy