Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-85
SponsorTartu University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fontaine I-IV class symptoms
Confirmed diagnosis of LEAD
Age 35-85
Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes
Disqualifiers
Age <35 or >85 years
BMI ≥40 kg/m²
Known heart failure in history
Any acute or chronic autoimmune or rheumatic disease
Trial population
Patients with cardiovascular risk factors
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
162 Participants
are grouped into 2 trial groupsGroup A: LEAD
Group B: Controls
Trial outcomes
Primary outcomes
1
left ventricular global longitudinal strain (GLS)
assessed by deformation analysis with echocardiography
Time frame
after enrollment and one year laterSecondary 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 later2
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 later3
arterial stiffness
peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta
Time frame
after enrollment and one year later4
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 laterSponsors and contacts
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Source ClinicalTrials.gov