Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Conditions

Non-ischemic Dilated Cardiomyopathy

Brief summary

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.

Detailed description

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.

Schons M, Pilgram L, Reese JP, Stecher M, Anton G, Appel KS, Bahmer T, Bartschke A, Bellinghausen C, Bernemann I, Brechtel M, Brinkmann F, Brünn C, Dhillon C, Fiessler C, Geisler R, Hamelmann E, Hansch S, Hanses F, Hanß S, Herold S, Heyder R, Hofmann AL, Hopff SM, Horn A, Jakob C, Jiru-Hillmann S, Keil T, Khodamoradi Y, Kohls M, Kraus M, Krefting D, Kunze S, Kurth F, Lieb W, Lippert LJ, Lorbeer R, Lorenz-Depiereux B, Maetzler C, Miljukov O, Nauck M, Pape D, Püntmann V, Reinke L, Römmele C, Rudolph S, Sass J, Schäfer C, Schaller J, Schattschneider M, Scheer C, Scherer M, Schmidt S, Schmidt J, Seibel K, Stahl D, Steinbeis F, Störk S, Tauchert M, Tebbe JJ, Thibeault C, Toepfner N, Ungethüm K, Vadasz I, Valentin H, Wiedmann S, Zoller T, Nagel E, Krawczak M, von Kalle C, Illig T, Schreiber S, Witzenrath M, Heuschmann P, Vehreschild JJ, NAPKON Research Group.

2022-07-2940 citations

10.1007/s10654-022-00896-z

Interventions

OTHERICD/CRT-D implantation

ICD/CRT-D implantation (if indicated)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* NIDCM (idiopathic or familial)\* * LVEF ≤35% and presence of fibrosis on CMR * Diagnostic CMR scan * Age ≥18 years * Written informed consent * Ability to give informed consent

Exclusion criteria

* ICM \[previous myocardial infarction, previous percutaneous coronary intervention\] * Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies \[e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy\], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies \[Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy\]. * Myocarditis * Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium) * Severe renal insufficiency (creatinine clearance \<30 mL/min) * Current pacemaker or defibrillator in situ * Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD) * Renal impairment defined as an eGFR \<30 milliliters * Age \<18 years * Patients presenting with pregnancy * Patients without informed consent * Participation in another randomized trial * Life expectancy \<2 years

Design outcomes

Primary

Measure	Time frame	Description
Death from any cause	Day 0	Death from any causes during follow-up - after discharge.

Countries

Germany

Contacts

Primary ContactIngo Eitel, Prof. Dr.

ingo.eitel@uksh.de+49 451 500 44501

Backup ContactThomas Stiermaier, Dr.

thomas.stiermaier@uksh.de+49 451 500 44501

Outcome results

None listed