Evaluating Cardiac Contractility Modulation Therapy in Heart Failure Patients
Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure
This study is testing if a new heart therapy called Cardiac Contractility Modulation can help heart failure patients better manage their medications over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Impulse Dynamics Industry-sponsored |
| Locations | 2 sites (Rome, Italy and 1 other locations) |
| Trial ID | NCT06580392 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effects of Cardiac Contractility Modulation (CCM) therapy on the initiation and adjustment of Guideline-Directed Medical Therapy (GDMT) in patients suffering from heart failure. It involves a prospective, non-randomized analysis of medication use and dosing before and after the CCM therapy. A total of 100 subjects will be enrolled, and their Quad Medication Score (QMS) will be evaluated at baseline and again at 6 and 12 months following the CCM device implant to determine the therapy's impact on medication optimization.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with symptomatic heart failure and reduced ejection fraction (LVEF ≤40%).
Not a fit: Patients with a Quad Medication Score greater than 5 or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance medication management for heart failure patients, potentially improving their overall health outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing heart failure treatment through device-assisted therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome, Italy and 1 other locations
- Gemelli University Hospital — Rome, Italy, Italy (Recruiting)
- AO dei Colli - O.Monaldi — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Gary Cranke
- Email: gcranke@impulsedynamics.com
- Phone: (856) 642-9933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.