Provocative Tests for HFpEF

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT06309550
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-10
• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• dyspnea

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Exclusion Criteria

• known HFpEF

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	5 years	Incidence of mortality
Hospitalization for heart failure	5 years	Incidence of hospitalization for heart failure
Atrial fibrillation	5 years	Incidence of atrial fibrillation

Trial Locations

Locations (1)

Ospedale San Luca IRCCS Istituto Auxologico Italiano; 🇮🇹 Milan, Italy