Clinical trial NCT05903586: Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy
Official title: Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy Using Ballon Angioplasty or Stent Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Isthmus Stenosis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)

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.

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)

Primary outcomes:
measure: change in central systolic blood pressure (BP) (mmHg) measured using pulse wave analysis
timeFrame: 4 weeks
Secondary outcomes:
measure: change in central diastolic blood pressure (BP) (mmHg) measured using pulse wave analysis
timeFrame: 4 weeks
measure: change in central pulse pressure measured (mmHg) using pulse wave analysis
timeFrame: 4 weeks
measure: change in augmentation index (-) measured using pulse wave analysis
timeFrame: 4 weeks
measure: change in pulse wave velocity (m/s)
timeFrame: 4 weeks
measure: change in systolic and diastolic office BP (mmHg)
timeFrame: 4 weeks
measure: change in systolic and diastolic 24 hour ambulatory BP (mmHg)
timeFrame: 4 weeks
measure: change in retinal arteriolar wall to lumen ratio (-) measured using Scanning Laser Doppler Flowmetry
timeFrame: 4 weeks
measure: change in retinal capillary flow (AU) measured using Scanning Laser Doppler Flowmetry
timeFrame: 4 weeks
measure: change in retinal capillary density measured using Scanning Laser Doppler Flowmetry
timeFrame: 4 weeks
measure: change in flow dependent vasodilation measured using the Unex Device
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen
Study officials:
References: