Actively Recruiting
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
Led by Impulse Dynamics · Updated on 2025-07-11
200
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years and older) diagnosed with symptomatic heart failure
- Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is 40% or less
- 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 if it was placed more than 1 year ago
- Patients with CRT device are functional class NYHA III-IV
You will not qualify if you...
- Patients unlikely to follow medical therapy for reasons other than intolerance or contraindications
- Patients with a Quad Medication Score (QMS) greater than 5
- Patients with estimated glomerular filtration rate (eGFR) less than 15
- Patients with a concomitant CRT device already implanted and considered a responder
- Patients with a class I indication for a concomitant CRT device
- Patients with significant other medical conditions that may interfere with study assessments
- Patients with contraindications to CCM therapy or unable to undergo device implantation
- Patients with severe stenotic valve disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Gemelli University Hospital
Rome, Italy, Italy
Actively Recruiting
2
AO dei Colli - O.Monaldi
Naples, Italy
Actively Recruiting
Research Team
G
Gary Cranke
CONTACT
R
Rachael Riccitello
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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