CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
Recruiting · NCT06580392 · Observational (researchers observe without assigning treatment) · Lead sponsor: Impulse Dynamics
View the official record on ClinicalTrials.gov →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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed.
- AO dei Colli - O.Monaldi - Naples, Italy
- Gemelli University Hospital - Rome, Italy, Italy