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

Heart Failure Clinical Trial

— MEDAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215248
• Other study ID #: 23105
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Tartu University Hospital
• Contact: Jaak Kals, PhD
• Phone: 731 8292
• Email: jaak.kals[@]ut.ee
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular global longitudinal strain (GLS)	assessed by deformation analysis with echocardiography	after enrollment and one year later
Secondary	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	after enrollment and one year later
Secondary	heart failure diagnosis	according to European Society of Cardiology year 2021 heart failure guideline (i.e assessment of symptoms, ECG, natriuretic peptides)	after enrollment and if necessary, reassessment one year later
Secondary	arterial stiffness	peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta	after enrollment and one year later
Secondary	cardiac- and renal injury markers	high-sensitivoty troponin T, natriuretic peptides (NT-proBNP), cystatine C, creatinine, urea, calculated eGFR	after enrollment and one year later
Secondary	metabolomics	low molecular weight metabolites	after enrollment and one year later
Secondary	markers of oxidative stress	oxidated LDL, interleukine-18, myeloperoxidase, isoprostanes	after enrollment and one year later

External Links

•   Endothelial Research Centre