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Clinical trial Recruiting at 1 site Observational Ages 35 to 85

Heart muscle strain imaging in people with lower limb artery disease

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

Run by Tartu University Hospital · NCT06215248 · Data updated 2026-11-12

This study tests whether people with lower extremity arterial disease have subtle heart muscle problems detected by strain imaging that relate to changes in blood metabolites.

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Quick facts

Study typeObservational
Ages35 Years to 85 Years
SexAll
Enrollment162 (estimated)
SponsorTartu University Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Tartu)
StatusRecruiting
StartedFebruary 1, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedDecember 16, 2025
Trial IDNCT06215248 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 35–85 with confirmed lower extremity arterial disease (any Fontaine class), or control participants aged 35–85 who have hypertension, diabetes, coronary artery disease, or a history of smoking.

Probably not a fit

People outside the 35–85 age range or with known heart failure, significant structural heart disease, recent acute coronary syndrome or stroke, severe pulmonary disease, very high BMI (≥40), chronic severe kidney dysfunction, or implanted cardiac devices are excluded and unlikely to benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center observational study at Tartu University Hospital uses deformation (strain) echocardiography and blood metabolomic profiling to characterize cardiac dysfunction in patients with lower extremity arterial disease (LEAD). Investigators will enroll a LEAD group (Fontaine I–IV) and a control group aged 35–85 with cardiovascular risk factors, performing standardized echocardiographic strain analyses, blood sampling, and clinical assessment of target organ damage. No treatments are given; researchers will compare strain metrics and metabolite patterns between groups and correlate those measures with signs of organ damage. The approach aims to identify subclinical myocardial dysfunction and metabolic signatures associated with LEAD.

Why it matters

Potential benefit: If successful, the work could allow earlier detection and better risk stratification of heart damage in people with leg artery disease, supporting closer monitoring or earlier interventions.

How similar studies have gone: Echocardiographic strain imaging has previously detected subclinical cardiac dysfunction in vascular disease, but combining strain measures with metabolomic profiling specifically in LEAD is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Tartu University Hospital
    Tartu, Estonia     Recruiting

Study contacts

  • Principal investigator: Jaak Kals, PhD — Tartu University Hospital
  • Study coordinator: Jaak Kals, PhD
  • Email: jaak.kals@ut.ee
  • Phone: 731 8292

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.