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NCT06309550 Clinical Trial

Provocative Tests for HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

— TEST-PEF  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06309550
Other study ID # 09W002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2023
Est. completion date March 2028

Study information
Verified date March 2024
Source Istituto Auxologico Italiano
Contact Sergio Caravita, MD, PhD
Phone +39 02 619112930
Email s.caravita@auxologico.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date March 2028
Est. primary completion date March 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - dyspnea Exclusion Criteria: - known HFpEF

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• exercise test
exercise test

Locations
Country Name City State
Italy Ospedale San Luca IRCCS Istituto Auxologico Italiano Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Incidence of mortality 5 years
Primary Hospitalization for heart failure Incidence of hospitalization for heart failure 5 years
Primary Atrial fibrillation Incidence of atrial fibrillation 5 years
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