Heart TransplantNCT07431814
Registry for Longitudinal Evaluation of Heart Transplanted Patients
An observational study of Heart Transplant, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplant
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jun 2018to 29 Dec 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- -
- 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
Who cannot join
- Withdrawn of the consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Transplant
- Keywords
- heart transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mortality in Heart Transplant Recipients
The primary objective of this registry is to evaluate overall mortality of the cohort of heart transplanted patients at Fondazione IRCCS Policlinico San Matteo.
Measured: After 1 month, 6 months, one year, and 5 years
Secondary outcomes (1)
Cause-Specific Mortality, Morbidity, and Hospitalization
The secondary objective is to evaluate the specific mortality, morbidity and hospitalization
Measured: After 1 month, 6 months, one year, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start28 Jun 2018
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Turco, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431814
- Sponsor's protocol ID
- P_60156
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Longitudinal Evaluation of Heart Transplanted Patients
- ClinicalTrials.gov ID
- NCT07431814
- Acronym / sponsor ID
- P_60156
- Conditions
- Heart Transplant
- Keywords
- heart transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- -
- Give written informed consent to participate for the prospective evaluations
- Be a heart transplanted patient
- Be aged 18 years and over
Key exclusion criteria (1 listed)
- Withdrawn of the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Cause-Specific Mortality, Morbidity, and Hospitalization
Time frame: After 1 month, 6 months, one year, and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Mortality in Heart Transplant Recipients (time frame: After 1 month, 6 months, one year, and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.