Understanding heart mechanics in patients with aorta coarctation
Assessment of the Impact of Transcatheter Stenting of Aortic Coarctation on the Left Ventricular Afterload and Work Using Left Ventricular Pressure Volume Loops
This study looks at how stent therapy affects heart function in people with aorta coarctation to see if it helps improve their heart's performance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT05362721 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with coarctation of the aorta, a condition that affects the heart's ability to function properly. It aims to gather data on how current management strategies, particularly stent therapy, influence cardiac mechanics and workload. By utilizing pressure-volume loop catheterization, the study will assess the impact of these interventions on heart performance. The findings will help clarify the effectiveness of existing treatments and guide future management approaches.
Who should consider this trial
Good fit: Ideal candidates include children aged 6 and older and adults who are scheduled for elective cardiac catheterization and stent therapy for coarctation of the aorta.
Not a fit: Patients undergoing other interventions for coarctation or those with single ventricle physiology or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with coarctation of the aorta, enhancing their cardiac function and overall health.
How similar studies have performed: While there is existing research on coarctation of the aorta, this specific approach using pressure-volume loop catheterization is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation * Those who provide informed consent for study participant. Exclusion Criteria: * Children who undergo other interventions in addition to the coarctation * Children with single ventricle physiology. * Renal impairment * Participant unwilling to sign a consent form.
Where this trial is running
Los Angeles, California and 6 other locations
- Children's Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's Hospital of Boston — Boston, Massachusetts, United States (Recruiting)
- Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- University of Texas-Southwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Gurumurthy Hiremath — University of Minnesota
- Study coordinator: Brittany Faanes
- Email: grego318@umn.edu
- Phone: 612-625-5929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.