Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580392
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure Fix-GDMT-HF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cardiac Contractity Modulation CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 prepost CCM therapy The Fix-GDMT-HF study aims to enroll 100 subjects to complete the study with 12- month of follow-up in the investigational 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 optimizationMed op2 will be assessed after implantationapprox 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 optimalization 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 maximaloptimal 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
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
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 optimizationMed op2 will be assessed after implantationapprox 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 optimalization 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 maximaloptimal 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None