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Enrolling by invitation NCT07134621

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

Observational Coarctation of the Aorta

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coarctation of the Aorta. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Number of patients with EIH who also have signs of hypertensive heart disease. [Time frame: At enrolment.]
  • Number of patients with EIH and increased arterial stiffness. [Time frame: At enrolment.]
  • Number of patients with EIH and signs of hypertensive renal damage. [Time frame: At enrolment.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Slovenia · 1 center
  • UMC Ljubljana — Ljubljana

Identifiers

NCT: NCT07134621 · 0120-135/2023/6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗