Status:
RECRUITING
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
Lead Sponsor:
Impulse Dynamics
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief 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 patie...
Detailed Description
Design Prospective, non-randomized, comparison analysis of medication use and dosing at pre/post CCM therapy. The Fix-GDMT-HF study aims to enroll up to 200 subjects (100 in Investigational Arm and up...
Eligibility Criteria
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 QMS score \>5
- eGFR \<15
- 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 significant comorbidities or conditions that may interfere with the study assessments
- Patients with contraindications to CCM therapy or unable to undergo implantation
- Severe stenotic valve disease
Key Trial Info
Start Date :
February 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06580392
Start Date
February 1 2025
End Date
December 1 2027
Last Update
July 11 2025
Active Locations (2)
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1
Gemelli University Hospital
Rome, Italy, Italy
2
AO dei Colli - O.Monaldi
Napoli, Italy