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

NCT07134621 | Enrolling By Invitation

• 1 other identifier: 0120-135/2023/6
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coarctation of the Aorta

Outcome Measures

Primary Outcomes (3)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

SL (1)