Rationale and design of the PACIFIC-PRESERVED (PhenomApping, ClassIFication and Innovation for Cardiac dysfunction in patients with heart failure and PRESERVED left ventricular ejection fraction) study - 01/06/24
, Philip Janiak c, Philippe Boutinaud d, Pierre Boutouyrie a, e, Frédérique Chézalviel-Guilbert c, Jean-Joseph Christophe f, Ariel Cohen g, Thibaud Damy h, Juliette Djadi-Prat i, Hüseyin Firat j, Pierre-Yves Hervé d, Richard Isnard k, Guillaume Jondeau l, Elie Mousseaux a, m, Mathieu Pernot n, Pierre Prot o, Benoit Tyl p, Gilles Soulat a, m, Damien Logeart qon behalf of the
PACIFIC consortium
Graphical abstract |
Highlights |
• | PACIFIC-PRESERVED is a prospective multicentre observational cohort study. |
• | Study designed to perform multidimensional deep phenotyping of patients with HFpEF. |
• | Patients with HFrEF and subjects without overt HF also enrolled as comparators. |
• | Ratio of HFpEF:HFrEF:no overt HF=3:2:1. |
• | HFpEF defined as LVEF≥50%; HFrEF defined as LVEF≤40%. |
• | Platform study to enable standard and innovative measurements in enrolled patients. |
• | Will foster development of innovative strategies for HFpEF diagnosis/stratification. |
• | Aim is to redefine phenotypic spectrum of HFpEF using machine-learning techniques. |
Abstract |
Background |
Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous syndrome that is poorly defined, reflecting an incomplete understanding of its pathophysiology.
Aim |
To redefine the phenotypic spectrum of HFpEF.
Methods |
The PACIFIC-PRESERVED study is a prospective multicentre cohort study designed to perform multidimensional deep phenotyping of patients diagnosed with HFpEF (left ventricular ejection fraction≥50%), patients with heart failure with reduced ejection fraction (left ventricular ejection fraction≤40%) and subjects without overt heart failure (3:2:1 ratio). The study proposes prospective investigations in patients during a 1-day hospital stay: physical examination; electrocardiogram; performance-based tests; blood samples; cardiac magnetic resonance imaging; transthoracic echocardiography (rest and low-level exercise); myocardial shear wave elastography; chest computed tomography; and non-invasive measurement of arterial stiffness. Dyspnoea, depression, general health and quality of life will be assessed by dedicated questionnaires. A biobank will be established. After the hospital stay, patients are asked to wear a connected garment (with digital sensors) to collect electrocardiography, pulmonary and activity variables in real-life conditions (for up to 14 days). Data will be centralized for machine-learning-based analyses, with the aim of reclassifying HFpEF into more distinct subgroups, improving understanding of the disease mechanisms and identifying new biological pathways and molecular targets. The study will also serve as a platform to enable the development of innovative technologies and strategies for the diagnosis and stratification of patients with HFpEF.
Conclusions |
PACIFIC-PRESERVED is a prospective multicentre phenomapping study, using novel analytical techniques, which will provide a unique data resource to better define HFpEF and identify new clinically meaningful subgroups of patients.
Le texte complet de cet article est disponible en PDF.Keywords : Heart failure, Heart failure with preserved ejection fraction, Machine learning, Phenomapping, Diagnosis
Plan
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Vol 117 - N° 5
P. 332-342 - mai 2024 Retour au numéro
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