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Recruiting NCT06309550

Provocative Tests for HFpEF

Observational Heart Failure With Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exercise test.
Who it may be relevant to
Registry conditions: Heart Failure With Preserved Ejection Fraction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Provocative Tests for Diagnosing and Phenotyping Heart Failure With Preserved Ejection Fraction

Overview

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.

Interventions

  • Diagnostic test exercise test
    exercise test

Primary outcome measures

  • Mortality [Time frame: 5 years]
  • Hospitalization for heart failure [Time frame: 5 years]
  • Atrial fibrillation [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • dyspnea

Exclusion criteria

  • known HFpEF

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Ospedale San Luca IRCCS Istituto Auxologico Italiano — Milan

Identifiers

NCT: NCT06309550 · 09W002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗