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Clinical Trials/NCT06309550
NCT06309550
Recruiting
Not Applicable

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

Istituto Auxologico Italiano1 site in 1 country500 target enrollmentMarch 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
Istituto Auxologico Italiano
Enrollment
500
Locations
1
Primary Endpoint
Mortality
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2023
End Date
March 1, 2028
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • known HFpEF

Outcomes

Primary Outcomes

Mortality

Time Frame: 5 years

Incidence of mortality

Hospitalization for heart failure

Time Frame: 5 years

Incidence of hospitalization for heart failure

Atrial fibrillation

Time Frame: 5 years

Incidence of atrial fibrillation

Study Sites (1)

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