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Endomyocardial Biopsy clinical trials

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NCT ID: NCT04654988 Recruiting - Heart Failure Clinical Trials

Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.

IMPROVE-MC
Start date: December 1, 2022
Phase: Phase 4
Study type: Interventional

Myocarditis can result in numerous complications, but there is paucity of data regarding optimal therapy, short- and long-term effects of possibly effective immunosuppressive therapy. The IMPROVE-MC study will provide high-quality scientific data about efficacy and safety of immunosuppressive therapy, non-invasive (MRI, biomarkers) and invasive diagnostics tests (endomyocardial biopsy), and prognosis in myocarditis. The objective of this multicenter, prospective, randomized, double-blind placebo-controlled trial is to assess the efficacy and safety of 12 - month treatment with prednisone and azathioprine comparing to placebo on top of guideline-recommended medical therapy in patients with biopsy-proven virus negative myocarditis or inflammatory cardiomyopathy and reduced ejection fraction (LVEF ≤ 45%). The study will also assess persistence of the treatment effects after 12 months.

NCT ID: NCT03801681 Recruiting - Heart Failure Clinical Trials

ARrhythmias in MYocarditis

ARMY
Start date: November 1, 2018
Phase:
Study type: Observational [Patient Registry]

Myocarditis promotes the occurrence of serious cardiac arrhythmias and conduction disorders which may lead to sudden cardiac death, the need for catheter ablation of arrhythmia or implantation of a cardioverter-defibrillator or pacemaker. The aim of the study is to fill the evidence gap regarding the type and burden of arrhythmias in patients with myocarditis and their correlation with clinical parameters, biomarkers and additional tests. During a multi-center observational study, patients will be subjected to prolonged ECG monitoring. As a result, a risk scale will be created that can facilitate the identification of patients with an increased risk of arrhythmia and further specifying recommendations for therapeutic management.