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RecruitingNCT07757282LIPID-AFUpdated Aug 11, 2026

Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation

An observational study in Atrial Fibrillation (AF), sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

This prospective multi-cohort observational study evaluates the association between peripheral blood lipidomic and ceramide profiles and atrial fibrillation. The study hypothesis is that peripheral blood lipidomic features and ceramide-related profiles are associated with the presence of atrial fibrillation. Participants with atrial fibrillation and control participants with other cardiovascular diseases will be prospectively enrolled. Peripheral blood samples will be analyzed using untargeted lipidomic profiling in one cohort and targeted ceramide assays in another cohort.

Read the detailed description

Atrial fibrillation is a common cardiac arrhythmia associated with metabolic disturbance and cardiac remodeling. Lipid metabolism, including sphingolipid and ceramide metabolism, may be involved in the pathophysiology of atrial fibrillation. Further clinical evidence is needed to clarify whether peripheral blood lipidomic and ceramide profiles are associated with atrial fibrillation.

This study is designed as a prospective multi-cohort observational study. Participants will be classified into an atrial fibrillation group or a control group according to Holter monitoring and clinical information. Control participants will be patients with other cardiovascular diseases without documented atrial fibrillation. Peripheral blood samples will be collected for lipidomic or targeted ceramide analysis.

Untargeted lipidomic profiling will be used to evaluate peripheral blood lipidomic features in one cohort, and targeted ceramide assays will be used to evaluate peripheral blood ceramide profiles in another cohort. The overall purpose of this study is to explore the relationship between peripheral blood lipidomic and ceramide profiles and atrial fibrillation.

02

Conditions studied

  • Atrial Fibrillation (AF)

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population includes adult patients prospectively enrolled from clinical cardiovascular cohorts. Participants will include patients with atrial fibrillation diagnosed by Holter monitoring and control patients with other cardiovascular diseases without documented atrial fibrillation. All participants will provide peripheral blood samples for untargeted lipidomic profiling or targeted ceramide analysis.

Inclusion criteria

  • Adults aged 18 years or older.
  • Participants who are able to provide informed consent.
  • Participants diagnosed with atrial fibrillation based on Holter monitoring, or control participants with other cardiovascular diseases and no documented atrial fibrillation.
  • Participants with available peripheral blood samples for untargeted lipidomic profiling or targeted ceramide analysis.

Exclusion criteria

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent.
  • Missing key clinical information.
  • Missing or poor-quality peripheral blood samples unsuitable for lipidomic or targeted ceramide analysis.
  • Participants considered unsuitable for this study by the investigators.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cohort 1 Atrial Fibrillation Group

    Participants in cohort 1 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using untargeted lipidomic profiling.

    Other: Peripheral blood untargeted lipidomic profiling

  • Cohort 1 Control Group

    Control participants in cohort 1 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using untargeted lipidomic profiling.

    Other: Peripheral blood untargeted lipidomic profiling

  • Cohort 2 Atrial Fibrillation Group

    Participants in cohort 2 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using targeted ceramide assays.

    Other: Peripheral blood targeted ceramide assay

  • Cohort 2 Control Group

    Control participants in cohort 2 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using targeted ceramide assays.

    Other: Peripheral blood targeted ceramide assay

Interventions

  • OtherPeripheral blood untargeted lipidomic profiling

    Peripheral blood samples from cohort 1 will be analyzed using untargeted lipidomic profiling. No treatment or therapeutic intervention will be assigned by the investigators.

  • OtherPeripheral blood targeted ceramide assay

    Peripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays. No treatment or therapeutic intervention will be assigned by the investigators.

05

What researchers measure

Primary outcomes

  1. Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L

    The concentration of Cer(d18:1/18:1) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  2. Peripheral Serum Concentration of Cer(d18:1/16:0), nmol/L

    The concentration of Cer(d18:1/16:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

    Time frame: baseline

  3. Peripheral Serum Concentration of Cer(d18:1/18:0), nmol/L

    The concentration of Cer(d18:1/18:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  4. Peripheral Serum Concentration of Cer(d18:1/20:0), nmol/L

    The concentration of Cer(d18:1/20:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  5. Peripheral Serum Concentration of Cer(d18:1/22:0), nmol/L

    The concentration of Cer(d18:1/22:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  6. Peripheral Serum Concentration of Cer(d18:1/24:0), nmol/L

    The concentration of Cer(d18:1/24:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  7. Peripheral Serum Concentration of Cer(d18:1/24:1), nmol/L

    The concentration of Cer(d18:1/24:1) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  8. Normalized Relative Abundance of Serum Cer(d18:1/18:1), AU

    The normalized relative abundance of Cer(d18:1/18:1) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  9. Normalized Relative Abundance of Serum Cer(d18:1/16:0), AU

    The normalized relative abundance of Cer(d18:1/16:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  10. Normalized Relative Abundance of Serum Cer(d18:1/18:0), AU

    The normalized relative abundance of Cer(d18:1/18:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  11. Normalized Relative Abundance of Serum Cer(d18:1/20:0), AU

    The normalized relative abundance of Cer(d18:1/20:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  12. Normalized Relative Abundance of Serum Cer(d18:1/22:0), AU

    The normalized relative abundance of Cer(d18:1/22:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  13. Normalized Relative Abundance of Serum Cer(d18:1/24:0), AU

    The normalized relative abundance of Cer(d18:1/24:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

  14. Normalized Relative Abundance of Serum Cer(d18:1/24:1), AU

    The normalized relative abundance of Cer(d18:1/24:1) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

    Time frame: Baseline

06

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xian JiaotongUniversity
    Xi'an, Shaanxi 710061, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because the study involves clinical information and biological sample-related data. Data sharing is not planned beyond the approved study protocol and ethical approval.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07757282
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
She JianQing (First Affiliated Hospital Xian Jiaotong University, First Affiliated Hospital Xi'an Jiaotong University) — Principal investigator
First posted
Aug 11, 2026
Start date
Jun 15, 2017
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Weiyan Zhang
Contact
zwhy19324@gmail.com
0086-13571200428
Weiyan Zhang
Contact
3093887704@qq.com
0086-13571200428

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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