NCT06580392Recruiting
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 28 Aug 2024
- Start date
- Feb 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Impulse Dynamics
- Diseases
- Heart failure
- NCT number
- NCT06580392
What you commit to
- Study type: Observational
- Planned participants: 200
- From Feb 2025 to the primary completion date, Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications.
- 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 contraindications to CCM therapy or unable to undergo implantation
Other illness
- Patients with significant comorbidities or conditions that may interfere with the study assessments
- Severe stenotic valve disease
Lab values
- eGFR \<15
Other
- Patients with a QMS score \>5
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AO dei Colli - O.Monaldi Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Gemelli University Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.