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Recruiting NCT07497308

GDF-15 and Early Outcomes After LVAD Implantation

Observational Advanced Heart Failure Left Ventricular Assist Device Implantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Advanced Heart Failure, Left Ventricular Assist Device Implantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Early Postoperative Mortality [Time frame: 30 days after LVAD implantation]
Secondary outcome measures (1)
  • Postoperative Complications [Time frame: Up to 30 days after LVAD implantation]

Eligibility criteria

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Akdeniz University, Faculty of Medicine, Department of Anesthesiology and Reanimation — Antalya

Identifiers

NCT: NCT07497308 · AKD-LVAD-GDF15-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗