Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy Using Ballon Angioplasty or Stent Implantation

Conditions
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Aortic Isthmus Stenosis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central systolic blood pressure (BP) (mmHg) measured using pulse wave analysis | change in central systolic blood pressure (BP) (mmHg) between baseline and 4 weeks post intervention | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central diastolic blood pressure (BP) (mmHg) measured using pulse wave analysis | change in central diastolic blood pressure (BP) (mmHg) between baseline and 4 weeks post intervention | 4 weeks | 
| change in central pulse pressure measured (mmHg) using pulse wave analysis | change in central pulse pressure (mmHg) between baseline and 4 weeks post intervention | 4 weeks | 
| change in augmentation index (-) measured using pulse wave analysis | change in augmentation index (-) between baseline and 4 weeks post intervention | 4 weeks | 
| change in pulse wave velocity (m/s) | change in pulse wave velocity (m/s) between baseline and 4 weeks post intervention | 4 weeks | 
| change in systolic and diastolic office BP (mmHg) | change in systolic and diastolic office BP (mmHg) between baseline and 4 weeks post intervention | 4 weeks | 
| change in systolic and diastolic 24 hour ambulatory BP (mmHg) | change in systolic and diastolic 24 hour ambulatory BP (mmHg) between baseline and 4 weeks post intervention | 4 weeks | 
| change in retinal arteriolar wall to lumen ratio (-) measured using Scanning Laser Doppler Flowmetry | change in retinal arteriolar wall to lumen ratio between baseline and 4 weeks post intervention | 4 weeks | 
| change in retinal capillary flow (AU) measured using Scanning Laser Doppler Flowmetry | change in retinal capillary flow (AU) between baseline and 4 weeks post intervention | 4 weeks | 
| change in retinal capillary density measured using Scanning Laser Doppler Flowmetry | change in retinal capillary density between baseline and 4 weeks post intervention | 4 weeks | 
| change in flow dependent vasodilation measured using the Unex Device | change in flow dependent vasodilation between baseline and 4 weeks post intervention | 4 weeks |