End-stage Heart FailureNCT07382284
Long-Term Survival After LVAD Implantation in End-Stage Heart Failure
An observational study of End-stage Heart Failure, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-stage Heart Failure
- What is being tested?
- Left Ventricular Assist Device (LVAD) implantation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2022to 1 Aug 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of adult patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation as part of routine clinical care. Participants are primarily enrolled from Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhejiang University School of Medicine; and The First Affiliated Hospital of Harbin Medical University. A smaller number of patients are also enrolled from Jinan Central Hospital and the Affiliated Hospital of Yangzhou University. All participating centers are tertiary referral hospitals with established LVAD programs.
Who may be able to join
- Adults aged ≥18 years
- Diagnosis of end-stage heart failure refractory to optimal medical therapy
- Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care
- Able to provide written informed consent for participation and biospecimen collection
- Willing and able to comply with study procedures and long-term follow-up
- Availability of left ventricular apical myocardial tissue obtained during LVAD implantation surgery
- Availability of peripheral blood samples collected during routine clinical care
- Patients treated at participating study centers
Who cannot join
- Age <18 years
- Prior implantation of a durable mechanical circulatory support device
- Concomitant heart transplantation at the time of index surgery
- Congenital heart disease requiring complex surgical repair
- Active systemic infection or sepsis at the time of LVAD implantation
- Known active malignancy with a life expectancy <1 year
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- Severe non-cardiac comorbidities limiting expected survival to less than 1 year (e.g., advanced liver failure, end-stage renal disease not eligible for renal replacement therapy)
- Inability or unwillingness to provide informed consent
- Pregnancy or breastfeeding at the time of enrollment
- Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses
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
+86 025 83106666
Nanjing, Jiangsu, 210000
Hai-Tao Zhang, M.D, +86 15210143301, zhanght_pumc@126.com
About this study
Official title: Long-Term Survival After Left Ventricular Assist Device Support (LVAD) Implantation in Patients With End-Stage Heart Failure: A Prospective, Observational, Multi-Center Cohort Study
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.
Patients receiving LVAD implantation as part of routine clinical care will be enrolled and followed for up to 3-5 years. During the study period, data will be collected on baseline characteristics, preoperative medical therapy, intraoperative surgical information, in-hospital course, and long-term postoperative medication use, as well as survival status, major clinical outcomes, LVAD-related complications, and hospital readmissions.
Read more
In addition, myocardial tissue samples will be obtained from the left ventricular apex during LVAD implantation surgery. These tissue samples are routinely removed as part of the standard surgical procedure and would otherwise be discarded after pathological examination. Peripheral blood samples will also be collected at predefined time points as part of routine clinical blood testing. No additional surgical procedures or invasive interventions are required for this study.
This study does not involve any experimental treatment or changes to standard medical care. All treatments and follow-up assessments are determined by the treating physicians according to routine clinical practice.
The purpose of this study is to improve understanding of long-term outcomes after LVAD implantation and to explore potential biological factors associated with prognosis in patients with end-stage heart failure.
- Conditions
- End-stage Heart Failure
- Being tested
- Left Ventricular Assist Device (LVAD) implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Ventricular Assist Device (LVAD) implantationOther
Also called Mechanical circulatory support implantation
Left ventricular assist device (LVAD) implantation performed as part of routine clinical care for patients with end-stage heart failure. This study is observational in nature and does not assign, alter, or mandate any intervention. The decision to implant an LVAD, the type of device used, perioperative management, and postoperative treatment are determined solely by the treating clinical team according to standard clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response after LVAD implantation
Patients will be classified as responders or non-responders based on predefined criteria.
Measured: During longitudinal follow-up up to 5 years after LVAD implantation
Secondary outcomes (1)
Genetic and molecular correlates of clinical response after LVAD implantation
Genetic and molecular analyses will be performed using myocardial tissue obtained from the left ventricular apex during LVAD implantation and peripheral blood samples collected during routine clinical care. Genome-wide association analyses and expression quantitative trait locus (eQTL) analyses will be conducted to explore associations between genetic variation, gene expression profiles, and long-term clinical response after LVAD implantation. These analyses are exploratory and aim to characterize the biological background underlying heterogeneity in myocardial recovery among patients with end-stage heart failure.
Measured: Assessed during follow-up up to 3-5 years after LVAD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start17 Jul 2022
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (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 End-stage Heart FailureStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Yangzhou University, Qianfoshan Hospital, Xinhua Hospital of Ili Kazak Autonomous Prefecture, First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382284
- Sponsor's protocol ID
- 2024-577-02
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data, including genetic and molecular data generated from myocardial tissue and peripheral blood samples, will not be shared at this time due to ethical, legal, and regulatory considerations. In particular, the collection and use of human genetic data are subject to national regulations, and data sharing decisions will be evaluated after completion of data collection and analysis to ensure compliance with applicable laws and institutional policies.
Publications
Drakos SG, Badolia R, Makaju A, Kyriakopoulos CP, Wever-Pinzon O, Tracy CM, Bakhtina A, Bia R, Parnell T, Taleb I, Ramadurai DKA, Navankasattusas S, Dranow E, Hanff TC, Tseliou E, Shankar TS, Visker J, Hamouche R, Stauder EL, Caine WT, Alharethi R, Selzman CH, Franklin S. Distinct Transcriptomic and Proteomic Profile Specifies Patients Who Have Heart Failure With Potential of Myocardial Recovery on Mechanical Unloading and Circulatory Support. Circulation. 2023 Jan 31;147(5):409-424. doi: 10.1161/CIRCULATIONAHA.121.056600. Epub 2022 Nov 30.
PubMed 36448446
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Survival After Left Ventricular Assist Device Support (LVAD) Implantation in Patients With End-Stage Heart Failure: A Prospective, Observational, Multi-Center Cohort Study
- ClinicalTrials.gov ID
- NCT07382284
- Acronym / sponsor ID
- 2024-577-02
- Conditions
- End-stage Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Yangzhou University, Qianfoshan Hospital, Xinhua Hospital of Ili Kazak Autonomous Prefecture, First Affiliated Hospital of Zhejiang University
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 2 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.
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.
Patients receiving LVAD implantation as part of routine clinical care will be enrolled and followed for up to 3-5 years. During the study period, data will be collected on baseline characteristics, preoperative medical therapy, intraoperative surgical information, in-hospital course, and long-term postoperative medication use, as well as survival status, major clinical outcomes, LVAD-related complications, and hospital readmissions.
In addition, myocardial tissue samples will be obtained from the left ventricular apex during LVAD implantation surgery. These tissue samples are routinely removed as part of the standard surgical procedure and would otherwise be discarded after pathological examination. Peripheral blood samples will also be collected at predefined time points as part of routine clinical blood testing. No additional surgical procedures or invasive interventions are required for this study.
This study does not involve any experimental treatment or changes to standard medical care. All treatments and follow-up assessments are determined by the treating physicians according to routine clinical practice.
The purpose of this study is to improve understanding of long-term outcomes after LVAD implantation and to explore potential biological factors associated with prognosis in patients with end-stage heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of adult patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation as part of routine clinical care. Participants are primarily enrolled from Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhejiang University School of Medicine; and The First Affiliated Hospital of Harbin Medical University. A smaller number of patients are also enrolled from Jinan Central Hospital and the Affiliated Hospital of Yangzhou University. All participating centers are tertiary referral hospitals with established LVAD programs.
Key inclusion criteria (8 listed)
- Adults aged ≥18 years
- Diagnosis of end-stage heart failure refractory to optimal medical therapy
- Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care
- Able to provide written informed consent for participation and biospecimen collection
- Willing and able to comply with study procedures and long-term follow-up
Key exclusion criteria (10 listed)
- Age <18 years
- Prior implantation of a durable mechanical circulatory support device
- Concomitant heart transplantation at the time of index surgery
- Congenital heart disease requiring complex surgical repair
- Active systemic infection or sepsis at the time of LVAD implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Ventricular Assist Device (LVAD) implantationAlso: Mechanical circulatory support implantationLeft ventricular assist device (LVAD) implantation performed as part of routine clinical care for patients with end-stage heart failure. This study is observational in nature and does not assign, alter, or mandate any intervention. The decision to implant an LVAD, the type of device used, perioperative management, and postoperative treatment are determined solely by the treating clinical team according to standard clinical practice. | Other | – |
Primary outcome
Clinical response after LVAD implantation
Time frame: During longitudinal follow-up up to 5 years after LVAD implantation
Patients will be classified as responders or non-responders based on predefined criteria.
1 secondary outcome
Genetic and molecular correlates of clinical response after LVAD implantation
Time frame: Assessed during follow-up up to 3-5 years after LVAD implantation
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 2 Feb 2026.
- Results publication: PubMed 36448446Drakos SG, Badolia R, Makaju A, Kyriakopoulos CP, Wever-Pinzon O, Tracy CM, Bakhtina A, Bia R, Parnell T, Taleb I, Ramadurai DKA, Navankasattusas S, Dranow E, Hanff TC, Tseliou E, Shankar TS, Visker J, Hamouche R, Stauder EL, Caine WT, Alharethi R, Selzman CH, Franklin S. Distinct Transcriptomic and Proteomic Profile Specifies Patients Who Have Heart Failure With Potential of Myocardial Recovery on Mechanical Unloading and Circulatory Support. Circulation. 2023 Jan 31;147(5):409-424. doi: 10.1161/CIRCULATIONAHA.121.056600. Epub 2022 Nov 30.
- Individual participant dataSharing planned: No. Individual participant data, including genetic and molecular data generated from myocardial tissue and peripheral blood samples, will not be shared at this time due to ethical, legal, and regulatory considerations. In particular, the collection and use of human genetic data are subject to national regulations, and data sharing decisions will be evaluated after completion of data collection and analysis to ensure compliance with applicable laws and institutional policies.
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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.
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 End-stage Heart Failure, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 8 inclusion and 10 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 2 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 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 Tuo Pan, M.D (+86 15205160210, pan_tuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response after LVAD implantation (time frame: During longitudinal follow-up up to 5 years after LVAD implantation). 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 NCT07382284, 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 2 Feb 2026.