Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy (ISTHA)

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Aortic Isthmus Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT05903586

ISTHA

Details and patient eligibility

About

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).

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

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)