Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| First Affiliated Hospital of Harbin Medical University | OTHER |
| Yangzhou University | OTHER |
| Qianfoshan Hospital | OTHER |
| Xinhua Hospital of Ili Kazak Autonomous Prefecture |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Ventricular Assist Device (LVAD) implantation | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response after LVAD implantation | Patients will be classified as responders or non-responders based on predefined criteria. | During longitudinal follow-up up to 5 years after LVAD implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuo Pan, M.D | Contact | +86 15205160210 | pan_tuo@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| +86 025 83106666 | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36448446 | Result | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| UNKNOWN |
| Zhejiang University | OTHER |
Not provided
Not provided
Not provided
Myocardial tissue samples obtained from the left ventricular apex during LVAD implantation surgery, which are routinely removed as part of standard surgical care and would otherwise be discarded after pathological examination, will be retained. Peripheral blood samples obtained from routine clinical blood testing will also be retained for research analyses.
| Assessed during follow-up up to 3-5 years after LVAD implantation |