Heart FailureRE-STARTNCT05775432
Prognosis of Heart Transplanted Patients With Heart Failure
An observational study of Heart Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Heart transplantation is the most effective treatment for end-stage heart failure, advanced cardiomyopathy, and complex congenital heart disease with severe heart failure or hypoxia. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Heart Failure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2023to 31 Dec 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation are enrolled into heart transplantation group. Individuals whose hearts are donated are enrolled into control group.
Who may be able to join
- Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation
- Individuals whose hearts are donated
Who cannot join
- Patients refuse to sign informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Guoliang Li, liguoliang_med@163.com
Yang Yan, +862985323865, yangyan3@xjtu.edu.cn
About this study
Official title: Prognosis of Heart Transplanted Patients With Heart Failure (RE-START): a National Multi-center, Retrospective-prospective, Cohort Study
Heart transplantation is the most effective treatment for end-stage heart failure, advanced cardiomyopathy, and complex congenital heart disease with severe heart failure or hypoxia. Several clinical studies have shown significant differences in the prognosis of heart transplantation patients with different etiologies, and post-transplantation complications are an important factor affecting patient survival, and there is still a lack of overall prognostic stratification and extensive clinical studies on risk factors after heart transplantation. Therefore, this study is intended to include patients who underwent heart transplantation for different etiologies of heart failure, collect clinical data and biological samples from patients, and use various techniques to deeply interpret the risk factors affecting the prognosis of heart transplantation patients and construct a prognostic prediction model to provide specific and individualized treatment ideas and theoretical basis for improving the survival rate of patients after heart transplantation.
- Conditions
- Heart Failure
- Keywords
- Heart transplantation, Heart failure, Prognosis
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart transplantation group | Patients with heart failure of different etiologies undergoing heart transplant. | |
| Control group | Individuals whose hearts are donated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of all-cause death
Death from any cause in patients after heart transplantation, will be assessed from medical records.
Measured: In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation.
Secondary outcomes (4)
Use of advanced life support (ALS)
Duration of ALS after heart transplantation, will be assessed from medical records.
Measured: In-hospital (an average of 1 month)
Incidence of postoperative complications
Postoperative complications after heart transplantation will be assessed from medical records.
Measured: In-hospital (an average of 1 month)
ICU admission time
ICU admission time after heart transplantation, will be assessed from medical records.
Measured: In-hospital (an average of 1 month)
Change of cardiac function index
Cardiac functional index after heart transplantation will be assessed by transthoracic echocardiography.
Measured: In-hospital (an average of 1 month).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start23 Apr 2023
- Primary completion31 Dec 2042 (estimated)
- Study completion31 Dec 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityYang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775432
- Sponsor's protocol ID
- XJTU1AF2023LSK-391
- Acronym
- RE-START
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cao Y, Xu L, Zhang M, Su A, Wang S, Li T, Liu S, Mao Z, He Y, Shao Z, Zhang J, Wang Y, Tian H, Sun Y, Li Y, Yan L, Zhang G, Sun S, Mei N, Chen F, Xiong Y, Liang G, Offermanns S, Yan Y, Yuan Z, Wang S. PIEZO1 regulates smooth muscle cell plasticity by integrating mechanical stretch with glycolytic metabolism. Cardiovasc Res. 2026 Apr 28;122(6):748-763. doi: 10.1093/cvr/cvag058.
PubMed 41846580
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Heart Transplanted Patients With Heart Failure (RE-START): a National Multi-center, Retrospective-prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT05775432
- Acronym / sponsor ID
- RE-START / XJTU1AF2023LSK-391
- Conditions
- Heart Failure
- Keywords
- Heart transplantation, Heart failure, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 31 Dec 2042 (estimated)
- Study completion
- 31 Dec 2042 (estimated)
- First posted
- 20 Mar 2023 (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.
Heart transplantation is the most effective treatment for end-stage heart failure, advanced cardiomyopathy, and complex congenital heart disease with severe heart failure or hypoxia. Several clinical studies have shown significant differences in the prognosis of heart transplantation patients with different etiologies, and post-transplantation complications are an important factor affecting patient survival, and there is still a lack of overall prognostic stratification and extensive clinical studies on risk factors after heart transplantation. Therefore, this study is intended to include patients who underwent heart transplantation for different etiologies of heart failure, collect clinical data and biological samples from patients, and use various techniques to deeply interpret the risk factors affecting the prognosis of heart transplantation patients and construct a prognostic prediction model to provide specific and individualized treatment ideas and theoretical basis for improving the survival rate of patients after heart transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart transplantation group | – | –Patients with heart failure of different etiologies undergoing heart transplant. |
| Control group | – | –Individuals whose hearts are donated. |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation are enrolled into heart transplantation group. Individuals whose hearts are donated are enrolled into control group.
Key inclusion criteria (2 listed)
- Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation
- Individuals whose hearts are donated
Key exclusion criteria (1 listed)
- Patients refuse to sign informed consent form
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
Change in the incidence of all-cause death
Time frame: In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation.
Death from any cause in patients after heart transplantation, will be assessed from medical records.
4 secondary outcomes
Use of advanced life support (ALS)
Time frame: In-hospital (an average of 1 month)
Incidence of postoperative complications
Time frame: In-hospital (an average of 1 month)
ICU admission time
Time frame: In-hospital (an average of 1 month)
Change of cardiac function index
Time frame: In-hospital (an average of 1 month).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 41846580Cao Y, Xu L, Zhang M, Su A, Wang S, Li T, Liu S, Mao Z, He Y, Shao Z, Zhang J, Wang Y, Tian H, Sun Y, Li Y, Yan L, Zhang G, Sun S, Mei N, Chen F, Xiong Y, Liang G, Offermanns S, Yan Y, Yuan Z, Wang S. PIEZO1 regulates smooth muscle cell plasticity by integrating mechanical stretch with glycolytic metabolism. Cardiovasc Res. 2026 Apr 28;122(6):748-763. doi: 10.1093/cvr/cvag058.
- Individual participant dataSharing planned: Undecided
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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.
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 2 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: looking for participants now, as of the sponsor's last update on 12 Jul 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoliang Li (+8613759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of all-cause death (time frame: In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775432, which also lists 1 linked publication.
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 12 Jul 2024.