drugset / Trial / NCT05025644

Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test

NCT05025644

Phase 4 Unknown 60 enrolled University Health Network, Toronto
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

The objectives of this study are to determine if the left ventricle outflow tract (LVOT) gradients may be reproduced with dobutamine (DBT) provocation test in obstructive HCM patients under general anesthesia and to analyze the change in anatomic LVOT area and pressure gradients (PG) before and after septal myectomy. If the DBT stress test can reproduce preoperative gradients in HCM patients during septal myectomy surgery, surgeons will have the opportunity to assess the quality of the surgical procedure depending on the obtained gradients with DBT stress test after surgery when gradients can't be reproduced during general anesthesia after myectomy, and decide if further myectomy is required, saving a re-operation on the patient in the future.

Timeline

Start
2023-03
Primary completion
2024-08
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Dobutamine Small molecule 5 ug/kg
Subject Dobutamine Small molecule 10 ug/kg
Subject Dobutamine Small molecule 15 ug/kg
Subject Dobutamine Small molecule 20 ug/kg