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NCT Number: NCT06309550

Provocative Tests for HFpEF

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.

Recruiting

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Luca IRCCS Istituto Auxologico Italiano

Milan, 20149, Italy

Location status: Recruiting

Location contact

Sergio Caravita, MD, PhD

CONTACT

[email protected]

+39 02 61911 2930

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • dyspnea

Exclusion criteria

  • known HFpEF

Treatment and study plan

Exercise test

Diagnostic Test

exercise test

Primary outcomes

  1. Mortality

    Time frame: 5 years

    Incidence of mortality

  2. Hospitalization for heart failure

    Time frame: 5 years

    Incidence of hospitalization for heart failure

  3. Atrial fibrillation

    Time frame: 5 years

    Incidence of atrial fibrillation

Study contacts

Contact information is provided by the study sponsor or research team.

Sergio Caravita, MD, PhD

CONTACT

[email protected]

+39 02 619112930

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: TEST-PEF

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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