The overall aim of the PROACT EU-Response project is to prepare Europe for future diseases of epidemic or pandemic potential by strengthening and building upon existing networks of experts and civil society focused on clinical therapeutic platform trials within hospital inpatient settings across Europe.
This network will provide the capacity to pivot rapidly in the event of an outbreak to implement large, multi-country platform trials investigating drug efficacy and performance of diagnostic tools, with a strong patient and public involvement. The civil society and community at large are engaged in the planning of the trials as well as in designing specific activities concerning communication and information for the public about health threats and how to avoid disinformation, particularly during an epidemic or pandemic.
This project is led by ANRS-MIE, Inserm and Sorbonne University, as part of a consortium of 20 European countries and 23 partners, including many teams in biostatistics, clinical research and social sciences, as well as numerous associations and citizens' groups.
Population: adult | Intervention type: Interventional Study

The objective of the study is to assess whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular (CV) outcomes in patients with heart failure (HF) with preserved or mildly reduced ejection fraction.

It used to be assumed that atrial fibrillation could cause heart failure, a condition known as tachycardiomyopathy. Today, it is known that the reverse can also occur, namely that heart failure triggers atrial fibrillation. The often rapid and irregular heartbeat that then occurs, in turn worsens the heart failure - a vicious circle begins. To counteract this dangerous combination of heart failure and atrial fibrillation, DZHK scientists are investigating in the CABA-HFPEF-DZHK27 study whether treatment of atrial fibrillation by so-called catheter ablation helps heart failure patients and has a positive effect on their state of health and prognosis. The study focuses on heart failure patients with preserved or only mildly reduced ejection fraction (Heart Failure with Preserved Ejection Fraction, HFPEF, and Heart Failure with mildly reduced Ejection Fraction, HFmrEF).

CABA-HFPEF-DZHK27 is now the first large, multicenter study to investigate this relationship. Across Europe, 60 centers are participating, and 1,550 patients with predefined inclusion and exclusion criteria are expected to participate through the centers. The study is designed to last five years.

Population: adult | Intervention type: therapeutic medical device