- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06309550
Provocative Tests for HFpEF (TEST-PEF)
March 7, 2024 updated by: Istituto Auxologico Italiano
Provocative Tests for Diagnosing and Phenotyping Heart Failure With Preserved Ejection Fraction
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sergio Caravita, MD, PhD
- Phone Number: +39 02 619112930
- Email: s.caravita@auxologico.it
Study Locations
-
-
-
Milan, Italy, 20149
- Recruiting
- Ospedale San Luca IRCCS Istituto Auxologico Italiano
-
Contact:
- Sergio Caravita, MD, PhD
- Phone Number: +39 02 61911 2930
- Email: s.caravita@auxologico.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
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
Description
Inclusion Criteria:
- dyspnea
Exclusion Criteria:
- known HFpEF
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 5 years
|
Incidence of mortality
|
5 years
|
Hospitalization for heart failure
Time Frame: 5 years
|
Incidence of hospitalization for heart failure
|
5 years
|
Atrial fibrillation
Time Frame: 5 years
|
Incidence of atrial fibrillation
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
March 7, 2024
First Submitted That Met QC Criteria
March 7, 2024
First Posted (Actual)
March 13, 2024
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09W002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure With Preserved Ejection Fraction
-
University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
-
Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
-
Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
-
Zhijun SunEnrolling by invitationHeart Failure | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
-
Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
-
Corvia MedicalWithdrawnHeart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction
-
Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
Clinical Trials on exercise test
-
M.D. Anderson Cancer CenterUnknownLung CancerUnited States
-
Great Ormond Street Hospital for Children NHS Foundation...CompletedCystic FibrosisUnited Kingdom
-
Freeman-Sheldon Research Group, Inc.CompletedObesity | Gender | Problem of AgingUnited States
-
University of AarhusCompleted
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingFabry Disease | Fabry Disease, Cardiac VariantNetherlands
-
University of ZurichNot yet recruiting
-
Centre Hospitalier Universitaire de BesanconUnknownVentilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD (CONvEX)Chronic Obstructive Pulmonary Disease SevereFrance
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia | Pulmonary Arteriovenous MalformationsUnited Kingdom
-
Samsung Medical CenterRecruitingHeart Failure With Preserved Ejection Fraction | Chronic Pulmonary Thromboembolism (Disorder)Korea, Republic of
-
Stony Brook UniversityUnknown