GDF-15 and Early Outcomes After LVAD Implantation (LVAD-GDF15)

March 24, 2026 updated by: Emel Gunduz, Akdeniz University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Please Select:
      • Antalya, Please Select:, Turkey (Türkiye), 07050
        • Recruiting
        • Akdeniz University, Faculty of Medicine, Department of Anesthesiology and Reanimation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:Adults aged 18 years and older

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 -

Exclusion Criteria:Age under 18 years

Active infection

Active malignancy

Severe hepatic failure

Missing study data

Refusal to participate

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Postoperative Mortality
Time Frame: 30 days after LVAD implantation
Mortality occurring during the early postoperative period after LVAD implantation
30 days after LVAD implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: Up to 30 days after LVAD implantation
Occurrence of early postoperative complications after LVAD implantatio
Up to 30 days after LVAD implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AKD-LVAD-GDF15-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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