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
Age ≥18 years Scheduled for elective or urgent CABG, valve replacement, or combined CABG and valve replacement Willing to wear the Skiin chest band for the duration of the study Have a smartphone with an Operating System compatible with the Skiin Connected Life App (Android 9+ or iOS 13+)
Exclusion criteria
Emergency indication for CABG, valve replacement, or combined CABG and valve replacement Prior cardiac surgery History of pre-operative persistent atrial fibrillation
Time frame: 3 months post-operation
To determine whether patients with elevated preoperative Lp(a) levels (≥125 nmol/L) have a higher incidence of POAF, as detected by 3 months of continuous ECG monitoring.
Time frame: 3 months post-operation
To determine whether patients with elevated preoperative Lp(a) levels (≥125 nmol/L) have a higher burden of POAF, defined as the total duration of AF episodes during the 3-month monitoring period.
Time frame: Tissue will be collected during surgery
To evaluate whether patients with increased incidence and burden of POAF have increased atrial fibrosis and inflammation, as measured by histological and transcriptional markers.
Time frame: Tissue will be collected during surgery
To evaluate whether patients with elevated pre-operative Lp(a) levels (≥125 nmol/L) have increased incidence and burden of POAF and increased atrial fibrosis and inflammation, as measured by histological and transcriptional markers.
Time frame: Blood will be collected at baseline, day 1 postoperative and day 30 pos-operative
To evaluate whether patients with elevated pre-operative Lp(a) levels (≥125 nmol/L) have increased serum inflammatory cytokine levels, as measured by ELISA.
Anthony Tang
Other
Acronym: LPa and POAF
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