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

April 29, 2026 updated by: University Medical Centre Ljubljana

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 14, 2025

First Submitted That Met QC Criteria

August 14, 2025

First Posted (Actual)

August 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-135/2023/6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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