CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImpulse Dynamics
About this trial
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 criteria
Qualifiers
Adults (≥18 years) diagnosed with symptomatic heart failure
Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%
CRT device has been implanted >1 year
Patients are functional class NYHA III-IV
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov