NCT06309550

Brief Summary

Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2023Mar 2028

Study Start

First participant enrolled

March 10, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

March 7, 2024

Last Update Submit

August 1, 2025

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (3)

  • Mortality

    Incidence of mortality

    5 years

  • Hospitalization for heart failure

    Incidence of hospitalization for heart failure

    5 years

  • Atrial fibrillation

    Incidence of atrial fibrillation

    5 years

Interventions

exercise testDIAGNOSTIC_TEST

exercise test

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients referred to the Dyspnea and Pulmonary Hypertension Center for suspicion of HF, PH or unexplained dyspnea

You may qualify if:

  • dyspnea

You may not qualify if:

  • known HFpEF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Luca IRCCS Istituto Auxologico Italiano

Milan, 20149, Italy

RECRUITING

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Central Study Contacts

Sergio Caravita, MD, PhD

CONTACT

+39 02 619112930s.caravita@auxologico.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 13, 2024

Study Start

March 10, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

August 3, 2025

Record last verified: 2025-08

Locations

IT(1)