NCT07497308

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Feb 2026Dec 2026

Study Start

First participant enrolled

February 4, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 19, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Left Ventricular Assist DeviceGDF-15Postoperative OutcomesEarly Mortality

Outcome Measures

Primary Outcomes (1)

  • Early Postoperative Mortality

    Mortality occurring during the early postoperative period after LVAD implantation

    30 days after LVAD implantation

Secondary Outcomes (1)

  • Postoperative Complications

    Up to 30 days after LVAD implantation

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 -

You may not qualify if:

  • Active infection
  • Active malignancy
  • Severe hepatic failure
  • Missing study data
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

RECRUITING

Central Study Contacts

emel gündüz, md

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 27, 2026

Study Start

February 4, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

December 23, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations