Target Organ Damage in Patients With Repaired Coarctation... | NCT07134621

Studies
Target Organ Damage in Patients With Repaired Coarctation of Aorta and Exercise Induced Hypertension

NCT07134621

Sponsor

University Medical Centre Ljubljana

Status

Enrolling by invitation

Last Update Posted

Apr 30, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Coarctation of the Aorta

Interventions

Not provided

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2025Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Aug 14, 2025

First Submission Date that Met QC Criteria

Aug 14, 2025

First Posted Date

Aug 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

Apr 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to obtain data on the effect of exercise induced hypertension on target organs in adult patients with repaired coarctation of the aorta. The main questions it aims to answer are:

patients with exercise induced hypertension have signs of hypertensive heart disease?
patients with exercise induced hypertension have increased arterial stiffness?
patients with exercise induced hypertension have signs of hypertensive renal damage? Participants will be invited for an outpatient appointment during which medical history and physical investigation will be performed. They will undergo cardiopulmonary exercise testing during which blood pressure will be measured regularly. Transthoracic echocardiography will also be performed as well as assessment of arterial stiffness by measuring pulse wave velocity. Renal function will be assessed by blood and urine analysis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with EIH who also have signs of hypertensive heart disease.		At enrolment.
Number of patients with EIH and increased arterial stiffness.		At enrolment.
Number of patients with EIH and signs of hypertensive renal damage.		At enrolment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients aged 18 years and older
history of coarctation of aorta repair

Exclusion Criteria:

haemodynamically significant recoarctation
arterial hypertension at rest
antihypertensive therapy
associated haemodynamically significant valvular heart disease
associated complex congenital heart disease
advanced heart failure
symptomatic arrhythmias
cognitive or physical limitations to perform exercise stress testing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients aged 18 years and older with repaired coarctation of aorta.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
UMC Ljubljana		Ljubljana		1000	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D001017	Aortic Coarctation

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided