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Recruiting NCT06215248

Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis

— Observational Peripheral Artery Disease Heart Failure

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: Peripheral Artery Disease, Heart Failure. Basic parameters: 35 years — 85 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
Estonia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease

Overview

Single centre observational study to assess lower extremity arterial disease (LEAD) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in LEAD.

Primary outcome measures

  • left ventricular global longitudinal strain (GLS) [Time frame: after enrollment and one year later]
Secondary outcome measures (6)
  • other echocardiographic parameters [Time frame: after enrollment and one year later]
  • heart failure diagnosis [Time frame: after enrollment and if necessary, reassessment one year later]
  • arterial stiffness [Time frame: after enrollment and one year later]
  • cardiac- and renal injury markers [Time frame: after enrollment and one year later]
  • metabolomics [Time frame: after enrollment and one year later]
  • markers of oxidative stress [Time frame: after enrollment and one year later]

Eligibility criteria

Inclusion Criteria in LEAD group:

  • Fontaine I-IV class symptoms
  • Confirmed diagnosis of LEAD

Inclusion Criteria in control group:

  • Age 35-85
  • Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes

Exclusion criteria

  • Age <35 or >85 years
  • BMI ≥40 kg/m²
  • Known heart failure in history
  • Any acute or chronic autoimmune or rheumatic disease
  • Cardiac structural disease in history: inflammatory, infiltrative diseases, nonischemic cardiomyopathies
  • Acute coronary syndrome in last 3 months
  • Moderate to severe cardiac valvular disease
  • Cardiac valvular disease operative/invasive treatment in history
  • Cardiac implantable electronic device (CIED)
  • Transitory ischemic attack or stroke in last 3 months
  • Severe COPD (GOLD C or D)
  • Moderate to severe asthma (according to GINA 2022 criteria)
  • Untreated hypertension (noninvasive blood pressure measurement ≥180/110 mmHg during recruitment)
  • Chronic severe kidney dysfunction (eGFR <30 ml/min/1,73 m²)
  • Malignant tumor with radiation treatment to thorax, oncologic or biologic treatment in history
  • Chronic hematologic disease (except for anemia)
  • Severe liver dysfunction
  • Malignant tumor with <5 years of remission
  • Acute or chronic infectious disease
  • Anemia with hemoglobin <80 g/L

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

Estonia · 1 center
  • Tartu University Hospital — Tartu

Identifiers

NCT: NCT06215248 · 23105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗