PATHFINDER-CHD: prospective registry on adults with congenital heart disease, abnormal ventricular function, and/or heart failure as a foundation for establishing rehabilitative, prehabilitative, preventive, and health-promoting measures: rationale, aims, design and methods
Authors: Freilinger Sebastian , Kaemmerer Harald , Pittrow Robert D. , Achenbach Stefan , Baldus Stefan , Dewald Oliver , Ewert Peter , Freiberger Annika , Gorenflo Matthias , Harig Frank , Hohmann Christopher , Holdenrieder Stefan , Hörer Jürgen , Huntgeburth Michael , Hübler Michael , Kohls Niko , Klawonn Frank , Kozlik-Feldmann Rainer , Kaulitz Renate , Loßnitzer Dirk , Mellert Friedrich , Nagdyman Nicole , Nordmeyer Johannes , Pittrow Benjamin A. , Pittrow Leonard B. , Rickers Carsten , Rosenkranz Stefan , Schelling Jörg , Sinning Christoph , Suleiman Mathieu N. , von Kodolitsch Yskert , von Scheidt Fabian , Kaemmerer-Suleiman Ann-Sophie 
Published: March 2024

Abstract
Background
Adults with congenital heart defects (ACHD) globally constitute a notably medically underserved patient population. Despite therapeutic advancements, these individuals often confront substantial physical and psychosocial residua or sequelae, requiring specialized, integrative cardiological care throughout their lifespan. Heart failure (HF) is a critical challenge in this population, markedly impacting morbidity and mortality.

Aims
The primary aim of this study is to establish a comprehensive, prospective registry to enhance understanding and management of HF in ACHD. Named PATHFINDER-CHD, this registry aims to establish foundational data for treatment strategies as well as the development of rehabilitative, prehabilitative, preventive, and health-promoting interventions, ultimately aiming to mitigate the elevated morbidity and mortality rates associated with congenital heart defects (CHD).

Methods
This multicenter survey will be conducted across various German university facilities with expertise in ACHD. Data collection will encompass real-world treatment scenarios and clinical trajectories in ACHD with manifest HF or at risk for its development, including those undergoing medical or interventional cardiac therapies, cardiac surgery, inclusive of pacemaker or ICD implantation, resynchronization therapy, assist devices, and those on solid organ transplantation.

Design
The study adopts an observational, exploratory design, prospectively gathering data from participating centers, with a focus on patient management and outcomes. The study is non-confirmatory, aiming to accumulate a broad spectrum of data to inform future hypotheses and studies.

Processes
Regular follow-ups will be conducted, systematically collecting data during routine clinical visits or hospital admissions, encompassing alterations in therapy or CHD-related complications, with visit schedules tailored to individual clinical needs.

Assessments
Baseline assessments and regular follow-ups will entail comprehensive assessments of medical history, ongoing treatments, and outcomes, with a focus on HF symptoms, cardiac function, and overall health status.

Discussion of the design
The design of the PATHFINDER-CHD Registry is tailored to capture a wide range of data, prioritizing real-world HF management in ACHD. Its prospective nature facilitates longitudinal data acquisition, pivotal for comprehending for disease progression and treatment impacts.

Conclusion
The PATHFINDER-CHD Registry is poised to offer valuable insights into HF management in ACHD, bridging current knowledge gaps, enhancing patient care, and shaping future research endeavors in this domain.