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RecruitingNCT06215248MEDALUpdated Dec 16, 2025

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

An observational study in Peripheral Artery Disease and Heart Failure, sponsored by Tartu University Hospital. Recruiting at 1 site in Estonia. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Tartu University Hospital · Observational

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
162
Ages
35 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Peripheral Artery Disease
  • Heart Failure
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 162 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Tartu University Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cardiovascular risk factors

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
162 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • LEAD

    LEAD diagnosis confirmed by by ankle-brachial index (≤0,9 or \>1,3) or angiography. Fontaine I-IV class symptoms.

  • Controls

    Matched with LEAD group's patients as much as possible for age, sex, smoking history, hypertension, diabetes, coronary artery disease.

06

What researchers measure

Primary outcomes

  1. left ventricular global longitudinal strain (GLS)

    assessed by deformation analysis with echocardiography

    Time frame: after enrollment and one year later

Secondary outcomes

  1. other echocardiographic parameters

    left ventricular ejection fraction, left atrial strain, lateral, medial and averaged E/E', left atrial volume, maximal tricuspid regurgitation velocity, right ventricular strain

    Time frame: after enrollment and one year later

  2. heart failure diagnosis

    according to European Society of Cardiology year 2021 heart failure guideline (i.e assessment of symptoms, ECG, natriuretic peptides)

    Time frame: after enrollment and if necessary, reassessment one year later

  3. arterial stiffness

    peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta

    Time frame: after enrollment and one year later

  4. cardiac- and renal injury markers

    high-sensitivoty troponin T, natriuretic peptides (NT-proBNP), cystatine C, creatinine, urea, calculated eGFR

    Time frame: after enrollment and one year later

  5. metabolomics

    low molecular weight metabolites

    Time frame: after enrollment and one year later

  6. markers of oxidative stress

    oxidated LDL, interleukine-18, myeloperoxidase, isoprostanes

    Time frame: after enrollment and one year later

07

Study locations

1 of 1 sites recruiting
  • Tartu University Hospital
    Tartu, Estonia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06215248
Lead sponsor
Tartu University Hospital
Responsible party
Jaak Kals (Professor of Vasology, Tartu University Hospital) — Principal investigator
First posted
Jan 22, 2024
Start date
Feb 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 16, 2025

Study contacts

Jaak Kals, PhD
Contact
jaak.kals@ut.ee
731 8292 ext. +372
Jaak Kals, PhD
principal investigator · Tartu University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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