Characterization of acute heart failure patients to guide clinical trial design

• Applicant: Dr. Benedikt Schrage
• Subject Area: Cardiology, Angiology
• Term: from 2019 to 2020
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 426451121

Acute heart failure is a serious disease associated with frequent hospitalizations and high health care costs. Affected patients have a 25% risk of re-hospitalization within one month after discharge and a 12-months all-cause mortality risk of up to 30%. Unfortunately, this high need for effective therapy is met by a significant gap in evidence. Indeed, no randomized controlled trial has yet provided any treatment affecting mortality endpoints in patients with acute heart failure. Heterogeneity of the patient population and incomplete understanding of the underlying disease seem to be responsible for this paucity of evidence. Available data on this topic mainly derive from small, single-center studies, leading to an insufficient characterization of the acute heart failure population. Importantly, this also includes a lack of knowledge on the role of distinct heart failure phenotypes in this setting. Registry-based studies offer the unique opportunity to perform a comprehensive investigation of this patient population and allow for a distinct characterization of specific sub-groups. These findings might then be used to guide clinical trial design and to optimize enrollment criteria. With the proposed project, the applicant will have the unique chance to investigate the acute heart failure population using the Swedish Heart Failure Registry. The Swedish Heart Failure Registry is the largest and most comprehensive research-registry covering the topic of heart failure. More than 60,000 individual heart failure patients are included in this registry, covering clinical and functional variables as well as a complete follow-up (including adjudicated end-points such as heart failure hospitalization and incident diseases). Due to the exceptional features of this registry, the applicant will be able to sufficiently characterize this patient population and to perform a distinctive risk stratification. In a second step, the applicant will use this registry-based characterization to optimize enrollment criteria for clinical trials covering acute heart failure patients and to guide trial design. Furthermore, the applicant will have the unique chance to participate in the first registry-based randomized trial on heart failure – SPIRRIT-HFpEF. This trial will investigate the effect of Spironolactone versus placebo in patients with a distinct heart failure phenotype. Using the existing structures of the Swedish Heart Failure Registry, the overall costs of this trial could be drastically reduced without impacting the scientific quality. The applicant will be directly involved in the conduction of this trial and will himself perform a sub-study on acute heart failure patients within the trial.

• DFG Programme: Research Fellowships
• International Connection: Sweden
• Host: Professor Lars Lund, Ph.D.