Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CMR-ICD-DZHK23 | Other Identifier | Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
Not provided
Not provided
Not provided
Not provided
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.
The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD group | Experimental | Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated. |
|
| Optimal HF care group | No Intervention | Patients receiving OMT and CRT pacemaker (CRT-P) implantation without a defibrillator if indicated. Patients without CRT indication will receive an ICM for detection of malignant VAs. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD/CRT-D implantation | Other | ICD/CRT-D implantation (if indicated) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | Death from any causes during follow-up - after discharge. | Day 0 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingo Eitel, Prof. Dr. | Contact | +49 451 500 44501 | ingo.eitel@uksh.de | |
| Thomas Stiermaier, Dr. | Contact | +49 451 500 44501 | thomas.stiermaier@uksh.de |
| Name | Affiliation | Role |
|---|---|---|
| Ingo Eitel, Prof. Dr. | Medical Clinic II - University Heart Center Lübeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität zu Lübeck | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided