Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
NCT07076329
Arrhythmias, Cardiac, Atrial Fibrillation
Florence, Italy
View Trial DetailsNCT Number: NCT07737444
About one in three patients who undergo open-heart surgery develop an irregular heart rhythm called postoperative atrial fibrillation (POAF). This condition increases the risk of stroke, prolongs hospital stays, and raises the chances of complications and death compared with patients who do not develop it. Because of these serious outcomes, researchers are working to identify which patients are most at risk.
One potential blood marker is lipoprotein(a), or Lp(a). Higher levels of Lp(a) have been linked to abnormal heart rhythms in previous studies. We want to determine whether patients with elevated Lp(a) are more likely to develop POAF after heart surgery and better understand the biological mechanisms behind this risk.
In this study, patients will be grouped based on whether they have high or low Lp(a) levels. All participants will wear a chest band monitor that continuously tracks heart rhythm for 3 months after surgery to detect POAF. During surgery, small tissue samples from the heart will also be collected. By examining these samples, we will assess whether patients with elevated Lp(a) show more scarring and inflammation which are two pathways known to cause abnormal heart rhythms.
The goal of this study is to determine whether elevated Lp(a) increases susceptibility to POAF. This could help identify patients who may benefit from preventive treatments and closer monitoring. By understanding how Lp(a) affects heart tissue, we also hope to uncover the mechanisms that contribute to abnormal rhythm and guide the development of future targeted therapies to treat POAF and other heart rhythms.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months post-operation
Incidence of Postoperative Atrial Fibrillation (POAF), as Detected by Continuous ECG Monitoring, Stratified by Preoperative Lp(a) Level (≥125 nmol/L vs <125 nmol/L)
Time frame: 3 months post-operation
Total Duration of POAF Episodes During the 3-Month Monitoring Period, Stratified by Preoperative Lp(a) Level (≥125 nmol/L vs <125 nmol/L)
Time frame: Tissue will be collected during surgery
Histological and Transcriptional Markers of Atrial Fibrosis and Inflammation in Left Atrial Appendage Tissue, Correlated with POAF Incidence and Burden
Time frame: Tissue will be collected during surgery
Histological and Transcriptional Markers of Atrial Fibrosis and Inflammation in Left Atrial Appendage Tissue, Stratified by Preoperative Lp(a) Level (≥125 nmol/L vs <125 nmol/L)
Time frame: Blood will be collected at baseline, day 1 postoperative and day 30 pos-operative
Serum Inflammatory Cytokine Levels, as Measured by ELISA, at Baseline, Postoperative Day 1, and Postoperative Day 90, Stratified by Preoperative Lp(a) Level (≥125 nmol/L vs <125 nmol/L)
Anthony Tang
Other
Acronym: LPa and POAF
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