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

Not yet recruiting

• Conditions: Heart Failure; Peripheral Artery Disease

• Registration Number: NCT06215248
• Lead Sponsor: Tartu University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
left ventricular global longitudinal strain (GLS)	after enrollment and one year later	assessed by deformation analysis with echocardiography

Secondary Outcome Measures

Name	Time	Method
other echocardiographic parameters	after enrollment and one year later	left ventricular ejection fraction, left atrial strain, lateral, medial and averaged E/E', left atrial volume, maximal tricuspid regurgitation velocity, right ventricular strain
heart failure diagnosis	after enrollment and if necessary, reassessment one year later	according to European Society of Cardiology year 2021 heart failure guideline (i.e assessment of symptoms, ECG, natriuretic peptides)
cardiac- and renal injury markers	after enrollment and one year later	high-sensitivoty troponin T, natriuretic peptides (NT-proBNP), cystatine C, creatinine, urea, calculated eGFR
arterial stiffness	after enrollment and one year later	peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta
metabolomics	after enrollment and one year later	low molecular weight metabolites
markers of oxidative stress	after enrollment and one year later	oxidated LDL, interleukine-18, myeloperoxidase, isoprostanes

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia