Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy

NCT ID: NCT05903586

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2025-05-01

Brief Summary

This controlled clinical study investigates arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of re-stenosis of the aortic isthmus (Recoarctatio Aortae).

Detailed Description

Patients with treated aortic isthmus stenosis during their first year of life often develop a Recoarctatio Aortae (re-stenosis of the aortic isthmus) in the long term followed by arterial hypertension. The Recoarctatio Aortae can be treated during a cather intervention by balloon dilatation or stent implantation. Patients with arterial hypertension often develop vascular remodeling with increased central systolic blood pressure and increased pulse pressure. Vascular remodling predics cardiovascular events and increases mortality. Vascular remodeling can be assessed non-invasively by using scanning laser doppler flowmetry (SLDF)), pulse wave analysis and measurement of flow-dependent vasodilation. In this controlled clinical study we investigate arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of Recoarctatio Aortae.

Conditions

Aortic Isthmus Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• male and female persons with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
• adequate contraceptive methods in females with childbearing potential

Exclusion Criteria

• other secondary causes for hypertension
• treatment resistent arterial hypertension or uncontrolled hypertension (office BP ≥ 180/110 mmHg)
• history of hypertensive enzephalopathy or intracerebral bleeding
• diabetes mellitus
• cataract
• known renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic, immunolic, hematologic, oncologic, neurologic or psychiatric diseases besides the diagnosis of artoic isthmus stenosis
• one of the following diseases or conditions during the last 6 months: myocardial infaction, instable angina pectoris, cardiac insufficiency
• pregnant or lactating woman or inadequate contraception (pearl-index ≥ 1%)
• participation in another clinical study
• drug or medication abuse
• inadequate adherence or other condition preventing the patient from study participation (in the eyes of the treating physician)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Agnes Bosch

Dr. med. Agnes Bosch, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen

Erlangen, , Germany

Countries

Germany

Other Identifiers

ISTHA

Identifier Type: -

Identifier Source: org_study_id