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NCT Number: NCT07497308

GDF-15 and Early Outcomes 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University, Faculty of Medicine, Department of Anesthesiology and Reanimation

Antalya, Please Select:, 07050, Turkey (Türkiye)

Location status: Recruiting

Location contact

emel gündüz

CONTACT

[email protected]

02422496000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Early Postoperative Mortality

    Time frame: 30 days after LVAD implantation

    Mortality occurring during the early postoperative period after LVAD implantation

Secondary outcomes

  1. Postoperative Complications

    Time frame: Up to 30 days after LVAD implantation

    Occurrence of early postoperative complications after LVAD implantatio

Study contacts

Contact information is provided by the study sponsor or research team.

emel gündüz, md

CONTACT

[email protected]

+902422496000

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Association of Preoperative GDF-15 Levels With Early Postoperative Outcomes and Mortality After LVAD Implantation

Acronym: LVAD-GDF15

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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