- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431814
Registry for Longitudinal Evaluation of Heart Transplanted Patients
February 20, 2026 updated by: Annalisa Turco, Fondazione IRCCS Policlinico San Matteo di Pavia
The overall objective of compiling this registry is to obtain a complete collection of data, in a dedicated database, on all patients who have undergone transplantation at our Center in order to assess the main causes of mortality, hospitalization, and morbidity.
Study Overview
Status
Completed
Conditions
Detailed Description
Secondary objective: the information acquired will enable us to review more appropriate outpatient management of these patients and redefine our internal management protocols in order to reduce morbidity, hospitalization, and mortality in these patients.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
-
-
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
Probability Sample
Study Population
The objective of the registry is to have an up-to-date, high quality and exhaustive data collection for the evaluation of the overall survival in the population of heart transplanted recipients and the incidence of hearth, kidney, infectious complications over the last thirty years and their determinants.
Description
Inclusion Criteria:
-
To be included in the study the patient must:
- Give written informed consent to participate for the prospective evaluations
- Be a heart transplanted patient
- Be aged 18 years and over
Exclusion Criteria:
- Withdrawn of the consent
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 |
|---|---|---|
|
Overall Mortality in Heart Transplant Recipients
Time Frame: After 1 month, 6 months, one year, and 5 years
|
The primary objective of this registry is to evaluate overall mortality of the cohort of heart transplanted patients at Fondazione IRCCS Policlinico San Matteo.
|
After 1 month, 6 months, one year, and 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cause-Specific Mortality, Morbidity, and Hospitalization
Time Frame: After 1 month, 6 months, one year, and 5 years
|
The secondary objective is to evaluate the specific mortality, morbidity and hospitalization
|
After 1 month, 6 months, one year, and 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 28, 2018
Primary Completion (Actual)
December 29, 2023
Study Completion (Actual)
December 29, 2023
Study Registration Dates
First Submitted
December 5, 2025
First Submitted That Met QC Criteria
February 20, 2026
First Posted (Actual)
February 25, 2026
Study Record Updates
Last Update Posted (Actual)
February 25, 2026
Last Update Submitted That Met QC Criteria
February 20, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P_60156
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.
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