MYOFLAME-19

Cardioprotective Treatment Trial in COVID-19 Related Myocardial Inflammation

Overview

MYOFLAME-19 is a randomized placebo-controlled clinical trial investigating cardioprotective treatment in previously healthy individuals with recent COVID-19 infection and cardiac symptoms.

ClinicalTrials.gov: NCT05619653

EU Clinical Trials Register: 2024-516463-84-00

Background

Following the findings from the Impression COVID Study demonstrating high rates of cardiac involvement in recovered COVID-19 patients, MYOFLAME-19 was initiated to evaluate whether cardioprotective treatment can improve outcomes in patients with COVID-19-related myocardial inflammation.

Study Population

Previously healthy individuals with:

  • Recent COVID-19 infection
  • Cardiac symptoms (shortness of breath on exertion, chest pain, tachycardia)
  • No prior known heart disease or significant comorbidities
  • CMR evidence of myocardial inflammation

Study Design

  • Design: Randomized, placebo-controlled clinical trial
  • Status: Recruitment completed, follow-up phase
  • Location: University Hospital Frankfurt and collaborating centers

Objectives

  1. Evaluate efficacy of cardioprotective treatment on myocardial inflammation
  2. Assess improvement in cardiac symptoms
  3. Monitor long-term cardiac outcomes

Relation to Other Studies

MYOFLAME-19 builds on the findings from:

  • Impression COVID Study — Observational study showing 78% cardiac involvement in recovered COVID-19 patients
  • Long-term follow-up studies showing persistent mild cardiac inflammation

Principal Investigators

  • Prof. Dr. Eike Nagel — University Hospital Frankfurt
  • PD Dr. Valentina Puntmann — University Hospital Frankfurt

Funding

  • German Centre for Cardiovascular Research (DZHK)
  • University Hospital Frankfurt