Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT06580392
Brief Summary:
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.
Detailed Description:
Design Prospective, non-randomized, comparison analysis of medication use and dosing at pre/post CCM therapy. The Fix-GDMT-HF study aims to enroll up to 200 subjects (100 in Investigational Arm and up to 100 in Registry Arm). Subjects identified not eligible to participate in the investigational arm can participate in the registry arm.
Method
* Subjects with QMS ≤ 5, eGFR ≥15, diagnosed symptomatic heart failure and LVEF ≤40% will be enrolled after review and approval by a member of the steering committee. Eligible subjects will receive CCM therapy and be enrolled in the investigational arm of the study. Medication optimization(Med op#2) will be assessed after implantation(approx. 3month post implant), followed by evaluation of QMS and other endpoints at 6 and 12 months. A target of 100 patients will be enrolled in the investigational arm.
* After medical optimization (Med op# 1), if the patient has QMS \> 5 or identified during SC review as not eligible to participate in investigational arm can participate in the registry arm. They will continue treatment guided by local practice (including potential CCM implant) with QMS assessment (and other data collection as patients in investigational arm) at 6- and 12-month visit. The registry arm will be restricted to 100 patients.
Endpoints
Primary Endpoint:
• Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant.
Secondary Endpoints:
* Change in loop diuretic dose from baseline to 6-month follow-up.
* Change in eGFR from baseline to 6-month follow-up.
* Change in SBP from baseline to 6-month follow-up.
* Adverse events (AEs) associated with CCM therapy.
* Change in HR among patients with concomitant cardiac rhythm management (CRM) devices.
* Percentage of patients achieving maximal/optimal GDMT following CCM therapy.
* GDMT adherence as measured by change in QMS score from 6 months (post-CCM) to 12 months (post-CCM).
Patients
Investigational arm - 100 subjects complete the study with 12- month of follow-up.
Registry arm - restricted to 100 subjects
Sites 10 sites in Germany \& Italy. 10 sites in the USA.
Duration
The entire study is expected to take approximately 24 months or (until the target number of subjects has been reached), including the enrolment and follow-up periods.
Study:
NCT06580392
Study Brief:
Protocol Section:
NCT06580392