Early Phase 1 N=27 Randomized Prevention

Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT04130061 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Number of Participants With Adverse Events — 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Human Amniotic Membrane (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	0; 0	—
PRIMARY Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls	5; 6	—
PRIMARY proBNP (Serum) Between Groups at Time of Surgery	198; 347	—
PRIMARY C-reactive Protein (Serum) Between Groups at Time of Surgery	0.34; 0.39	—
PRIMARY Interleukin-6 (Serum) Between Groups at Time of Surgery	2.25; 2.23	—
PRIMARY Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery	2.45; 3.63	—
PRIMARY proBNP (Serum) Between Groups at 24 Hours Post-op	1922.83; 2239.42	—
PRIMARY C-reactive Protein (Serum) Between Groups at 24-hours Post-op	14.94; 10.66	—
PRIMARY Interleukin-6 (Serum) Between Groups at 24-hours Post-op	26.95; 18.28	—
PRIMARY Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op	2.61; 2.87	—
PRIMARY proBNP (Serum) Between Groups at 48 Hours Post-op	6081.83; 7750.35	—
PRIMARY C-reactive Protein (Serum) Between Groups at 48 Hours Post-op	21.67; 15.71	—
PRIMARY Interleukin-6 (Serum) Between Groups at 48 Hours Post-op	12.32; 14.39	—
PRIMARY Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op	2.34; 2.27	—
PRIMARY proBNP (Serum) Between Groups at 72 Hours Post-op	2707.75; 449.71	—
PRIMARY CRP (Serum) Between Groups at 72 Hours Post-op	17.45; 14.21	—
PRIMARY Interleukin-6 (Serum) Between Groups at 72 Hours Post-op	5.81; 10.38	—
PRIMARY TNFa (Serum) Between Groups at 72 Hours Post-op	2.12; 2.38	—
PRIMARY proBNP (Serum) Between Groups at Follow-up	847; 1391.7	—
PRIMARY CRP (Serum) Between Groups at Follow-Up	0.975; 1.96	—
PRIMARY Interleukin-6 (Serum) Between Groups at Follow-up	2.37; 6.86	—
PRIMARY TNFa (Serum) Between Groups at Follow-up	2.11; 3.11	—
PRIMARY proBNP (Pericardial Fluid) Between Groups at Time of Surgery	1039.6; 1771.07	—
PRIMARY C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery	0.34; 0.39	—
PRIMARY Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery	30.3; 59.9	—
PRIMARY Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery	2.81; 2.77	—
PRIMARY proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op	6081.83; 7750.35	—
PRIMARY C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op	4.54; 2.84	—
PRIMARY Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op	88823.8; 67217.8	—
PRIMARY Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op	8.58; 10.35	—
PRIMARY proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op	8823.4; 10027.57	—
PRIMARY C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op	6.8; 4.9	—
PRIMARY Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op	64370.14; 45839.95	—
PRIMARY Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op	8.3; 8.03	—
PRIMARY proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op	3895.5; 8423	—
PRIMARY C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op	8.53; 6.35	—
PRIMARY Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op	9296.6; 25316.6	—
PRIMARY Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op	12.32; 8.38	—

Summary

This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.

Eligibility Criteria

Inclusion Criteria

Patients undergoing primary elective CABG at the University of Utah Hospital
Ability to provided informed consent and follow-up with protocol procedures

Exclusion Criteria

Patients in AF at the time of surgery
Prior history of sternotomy
Prior history of pericarditis
Currently on aggressive antiarrhythmic therapy (does not include beta blockers)
Patients with an implantable cardiac device (pacemaker, ICD, CRT-D)
Ejection fraction <45%

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04130061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.