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

Recruitingn/aAges 18 Years - anyAllImpulse Dynamics
NCT06580392 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

2 sites
Gemelli University Hospital
Rome, Italy
AO dei Colli - O.Monaldi
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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