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RecruitingNCT06309550TEST-PEFUpdated Aug 3, 2025

Provocative Tests for HFpEF

An observational study in Heart Failure With Preserved Ejection Fraction, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Istituto Auxologico Italiano · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure With Preserved Ejection Fraction
03

In context

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients referred to the Dyspnea and Pulmonary Hypertension Center for suspicion of HF, PH or unexplained dyspnea

Inclusion criteria

  • dyspnea

Exclusion criteria

Exclusion Criteria:

  • known HFpEF
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • Diagnostic testexercise test

    exercise test

06

What researchers measure

Primary outcomes

  1. Mortality

    Incidence of mortality

    Time frame: 5 years

  2. Hospitalization for heart failure

    Incidence of hospitalization for heart failure

    Time frame: 5 years

  3. Atrial fibrillation

    Incidence of atrial fibrillation

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Ospedale San Luca IRCCS Istituto Auxologico Italiano
    Milan, 20149, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06309550
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Mar 13, 2024
Start date
Mar 10, 2023
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 3, 2025

Study contacts

Sergio Caravita, MD, PhD
Contact
s.caravita@auxologico.it
+39 02 619112930

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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