Data-Driven Phenotyping in Heart Failure With Preserved Ejection Fraction

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto Politécnico de Leiria

About this trial

The goal of this observational study is to learn how people with Heart Failure with Preserved Ejection Fraction (HFpEF) can be grouped into different "phenotypes" based on their clinical information. The researchers want to understand whether these groups have different health profiles and different responses during a cardiopulmonary exercise test (CPET).

The main questions this study aims to answer are:

* Can clinical data be used to identify meaningful HFpEF phenotypes? * Do these phenotypes match well-known HFpEF scores, such as the H2FPEF and Heart Failure Association Pre-test Assessment, Echocardiography and Natriuretic Peptide (HFA-PEFF) scores? * Do people in different phenotypes show different results on a CPET?

Participants will:

* Have their past clinical records reviewed if they were diagnosed with HFpEF at the Local Health Unit of the Leiria Region (ULS RL); * A smaller group will attend one visit to complete a CPET, which measures how the heart, lungs and muscles respond during exercise.

This study includes adults aged 18 years or older who have HFpEF. The study does not involve any new treatments or experimental drugs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Established diagnosis of heart failure with preserved ejection fraction (LVEF ≥50%);

Patients receiving care (outpatient or inpatient) at the Local Health Unit of the Leiria Region (ULS RL) since September 2018.

Age ≥18 years;

Disqualifiers

Incomplete or inadequate medical records preventing full data extraction.

Medical contraindication or physical inability to perform cardiopulmonary exercise testing (CPET);

Inability to provide informed consent.

Trial population

Adult patients (≥18 years) with a confirmed diagnosis of heart failure with preserved ejection fraction (LVEF ≥50%) admitted in the Local Health Unit of the Leiria Region since September 2018. The retrospective phase includes electronic health records from approximately 200 patients, used to obtain multimodal datasets for unsupervised clustering. A cross-sectional phase recruits volunteer participants selected for representativeness of the identified phenotypes to undergo cardiopulmonary exercise testing (CPET) for functional characterization. Collected data include sociodemographic variables, clinical history, imaging findings, laboratory biomarkers (e.g., NT-proBNP), therapeutic data and CPET-derived functional parameters.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Observational HFpEF Cohort

Trial outcomes

Primary outcomes

1

Identification and characterization of HFpEF phenotypes using multimodal clustering analysis

Identification of distinct phenotypic clusters in patients with heart failure with preserved ejection fraction using unsupervised machine learning applied to multimodal clinical, biochemical, imaging and functional data.

Time frame
Up to December 2026 (completion of retrospective data collection and clustering analysis).

Secondary outcomes

1

Mean peak oxygen uptake (VO₂peak) during cardiopulmonary exercise testing

Peak oxygen uptake (VO₂peak), expressed in mL·kg-¹·min-¹, measured by breath-by-breath gas analysis during maximal cardiopulmonary exercise testing and compared across HFpEF phenotypes.

Time frame
December 2026 to July 2027 (single assessment per participant).
2

Concordance between H2FPEF and HFA-PEFF scores and identified HFpEF phenotypes

Assessment of concordance and discrimination performance of H2FPEF and HFA-PEFF scores in identifying phenotypes derived from data-driven clustering.

Time frame
Up to October 2027.
3

Mean plasma NT-proBNP concentration (pg/mL) by HFpEF phenotypes

Comparison of plasma NT-proBNP concentrations (pg/mL) between HFpEF phenotypes identified by clustering analysis.

Time frame
Up to February 2028.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Politécnico de Leiria

Lead sponsor

Faculty of Medicine of Universidade de Lisboa (FMUL)

Collaborator

Hospital Santo André - Centro Hospitalar de Leiria

Collaborator

Fundação para a Ciência e a Tecnologia (FCT)

Collaborator

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