Advanced Heart FailureLVAD-GDF15NCT07497308
GDF-15 and Early Outcomes After LVAD Implantation
An observational study of Advanced Heart Failure and Left Ventricular Assist Device Implantation, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to investigate the association between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Heart Failure, Left Ventricular Assist Device Implantation
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2026to 23 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with advanced heart failure undergoing LVAD implantation. Eligible participants are those with available preoperative GDF-15 measurements who meet the study inclusion and exclusion criteria.
Who may be able to join
- Patients with advanced heart failure undergoing LVAD implantation
- Availability of preoperative GDF-15 measurement
- Ability to provide written informed consent or consent provided by a legally authorized representative, according to local regulations -
Who cannot join
- Active infection
- Active malignancy
- Severe hepatic failure
- Missing study data
- Refusal to participate
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University, Faculty of Medicine, Department of Anesthesiology and Reanimation
Antalya, Please Select:, 07050
emel gündüz, 02422496000, dregunduz@hotmail.com
About this study
Official title: Association of Preoperative GDF-15 Levels With Early Postoperative Outcomes and Mortality After LVAD Implantation
This observational study aims to investigate the association between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation. The study will evaluate whether elevated preoperative GDF-15 levels are associated with adverse early outcomes, including postoperative complications and mortality. The findings may help improve preoperative risk assessment and identify high-risk patients before LVAD implantation.
Read the detailed description
Left ventricular assist device (LVAD) implantation is an established treatment option for patients with advanced heart failure. However, these patients remain at substantial risk for early postoperative morbidity and mortality. Identification of preoperative biomarkers associated with adverse outcomes may improve perioperative risk assessment and support clinical decision-making. Growth differentiation factor-15 (GDF-15) is a biomarker related to inflammation, oxidative stress, and cardiovascular injury, and may have prognostic value in high-risk cardiac populations.
This observational study will investigate the relationship between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing LVAD implantation. Preoperative serum GDF-15 levels will be evaluated for their association with early postoperative complications, mortality, and other short-term clinical outcomes.
The study is intended to clarify whether GDF-15 can serve as a useful biomarker for identifying patients at increased risk before LVAD implantation. Improved preoperative risk stratification may help optimize perioperative management and patient selection.
- Keywords
- Left Ventricular Assist Device, GDF-15, Postoperative Outcomes, Early Mortality
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 |
|---|---|---|
| Patients Undergoing LVAD Implantation | Patients with advanced heart failure undergoing left ventricular assist device (LVAD) implantation whose preoperative GDF-15 levels will be evaluated in relation to early postoperative outcomes and mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Mortality
Mortality occurring during the early postoperative period after LVAD implantation
Measured: 30 days after LVAD implantation
Secondary outcomes (1)
Postoperative Complications
Occurrence of early postoperative complications after LVAD implantatio
Measured: Up to 30 days 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 posted27 Mar 2026
- Study start4 Feb 2026
- Primary completion10 Aug 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Gunduz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497308
- Sponsor's protocol ID
- AKD-LVAD-GDF15-2026
- Acronym
- LVAD-GDF15
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preoperative GDF-15 Levels With Early Postoperative Outcomes and Mortality After LVAD Implantation
- ClinicalTrials.gov ID
- NCT07497308
- Acronym / sponsor ID
- LVAD-GDF15 / AKD-LVAD-GDF15-2026
- Keywords
- Left Ventricular Assist Device, GDF-15, Postoperative Outcomes, Early Mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 27 Mar 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 observational study aims to investigate the association between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation. The study will evaluate whether elevated preoperative GDF-15 levels are associated with adverse early outcomes, including postoperative complications and mortality. The findings may help improve preoperative risk assessment and identify high-risk patients before LVAD implantation.
Detailed description
Left ventricular assist device (LVAD) implantation is an established treatment option for patients with advanced heart failure. However, these patients remain at substantial risk for early postoperative morbidity and mortality. Identification of preoperative biomarkers associated with adverse outcomes may improve perioperative risk assessment and support clinical decision-making. Growth differentiation factor-15 (GDF-15) is a biomarker related to inflammation, oxidative stress, and cardiovascular injury, and may have prognostic value in high-risk cardiac populations.
This observational study will investigate the relationship between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing LVAD implantation. Preoperative serum GDF-15 levels will be evaluated for their association with early postoperative complications, mortality, and other short-term clinical outcomes.
The study is intended to clarify whether GDF-15 can serve as a useful biomarker for identifying patients at increased risk before LVAD implantation. Improved preoperative risk stratification may help optimize perioperative management and patient selection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing LVAD Implantation | – | –Patients with advanced heart failure undergoing left ventricular assist device (LVAD) implantation whose preoperative GDF-15 levels will be evaluated in relation to early postoperative outcomes and mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with advanced heart failure undergoing LVAD implantation. Eligible participants are those with available preoperative GDF-15 measurements who meet the study inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Patients with advanced heart failure undergoing LVAD implantation
- Availability of preoperative GDF-15 measurement
- Ability to provide written informed consent or consent provided by a legally authorized representative, according to local regulations -
Key exclusion criteria (6 listed)
- Active infection
- Active malignancy
- Severe hepatic failure
- Missing study data
- Refusal to participate
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
Early Postoperative Mortality
Time frame: 30 days after LVAD implantation
Mortality occurring during the early postoperative period after LVAD implantation
1 secondary outcome
Postoperative Complications
Time frame: Up to 30 days 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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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 Advanced Heart Failure and Left Ventricular Assist Device Implantation, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 27 Mar 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 Turkey (Türkiye). 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 emel gündüz, md (+902422496000, dregunduz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Postoperative Mortality (time frame: 30 days after LVAD implantation). 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 27 Mar 2026.