Data-Driven Phenotyping in Heart Failure With Preserved Ejection Fraction

NCT07429396 | Not Yet Recruiting

• 1 other identifier: FCT 2023.05000.BDANA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure; Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Heart Failure; HFpEF; Preserved Ejection Fraction; Phenotyping; Machine Learning; Data-driven clustering; Cardiopulmonary Exercise Testing; H2FPEF score; HFA-PEFF score; Exercise tolerance

Outcome Measures

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.

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

Secondary Outcomes (3)

• Mean peak oxygen uptake (VO₂peak) during cardiopulmonary exercise testing

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

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

  Up to October 2027.

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

  Up to February 2028.

Study Arms (1)

Observational HFpEF Cohort

Single observational cohort including all adults with an established diagnosis of heart failure with preserved ejection fraction (LVEF ≥50%) who received care at the Local Health Unit of the Leiria Region (ULS RL) since September 2018. Clinical, biochemical, imaging, functional, and therapeutic information recorded during previous hospitalizations will be extracted for retrospective analysis. A subset of participants will later be invited to complete a single cardiopulmonary exercise test (CPET) according to the study protocol. Phenotypes (clusters) will be identified post-hoc using unsupervised machine-learning methods and are not predefined at the time of enrollment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Retropective observational phase (Phase I):
• 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.
• Cross-sectional observational phase (Phase II - CPET):
• Age ≥18 years;
• Established diagnosis of HFpEF;
• Selection as a volunteer representative of phenotypes identified in the retrospective clustering analysis;
• Provision of written informed consent prior to any study-specific procedures.

You may not qualify if:

• Retropective observational phase (Phase I):
• Incomplete or inadequate medical records preventing full data extraction.
• Cross-sectional observational phase (Phase II - CPET):
• Medical contraindication or physical inability to perform cardiopulmonary exercise testing (CPET);
• Inability to provide informed consent.

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead
• 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

Study Sites (2)

Local Health Unit of the Leiria Region

Leiria, Leiria District, 2410-197, Portugal

Location

ciTechCare - Center for Innovative Care and Health Technology

Leiria, 2414-016, Portugal

Location

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MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rui M Fonseca-Pinto, PhD

  ciTechCare - Center for Innovative Care and Health Technology, Polytechnic of Leiria

  STUDY DIRECTOR

• João C A Morais, PhD

  ciTechCare - Center for Innovative Care and Health Technology, Polytechnic of Leiria

  STUDY DIRECTOR

• Vera L P Geraldes, PhD

  Faculty of Medicine, University of Lisbon

  STUDY DIRECTOR

Central Study Contacts

Sónia C Santos, MSc

CONTACT

+351910724415; sonia.c.santos@ipleiria.pt

Rui M Fonseca-Pinto, PhD

CONTACT

+351965632378; rui.pinto@ipleiria.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 24, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)