Exploring the Feasibility of Integrating Cardiopulmonary Exercise Testing, Echocardiography, and Biomarkers for Predicting Atrial Fibrillation Recurrence: Rationale, Design and Protocol for a Prospective Cohort Study (The PLACEBO Trial).

Background

Paroxysmal atrial fibrillation (PAF) presents significant challenges in management due to its unpredictable recurrence and associated complications. Current prognostic tools lack precision in predicting PAF outcomes, highlighting the need for a comprehensive approach integrating multiple diagnostic modalities.

Methods

The PLACEBO pilot study is a prospective observational investigation enrolling 80 adults with PAF from a tertiary hospital. Baseline assessments include cardiopulmonary exercise testing (CPET), a complete echocardiographic evaluation, 24-h ambulatory electrocardiographic monitoring, and plasma biomarker analysis. Participants will be followed for 12 months, with the primary outcome being AF recurrence. Secondary outcomes include cardiovascular events and other clinical indicators relevant to disease progression.

Results

The study will assess the feasibility of integrating CPET parameters, echocardiographic indices, and plasma biomarkers into clinical practice for prognostic evaluation. Data analysis will focus on identifying potential associations between these modalities and PAF recurrence, contributing to improved risk stratification.

Conclusions

By integrating CPET, echocardiographic parameters, and plasma biomarkers, the PLACEBO pilot study aims to enhance risk stratification and improve the prognostic assessment of patients with PAF. The findings from this study may pave the way for future research, ultimately contributing to the development of personalized management strategies.