Heart Failure, Peripheral Artery Disease
Conditions
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.
Interventions
None listed
Sponsors
Tartu University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular global longitudinal strain (GLS) | after enrollment and one year later | assessed by deformation analysis with echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| arterial stiffness | after enrollment and one year later | peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta |
| 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 |
| 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 |
Countries
Estonia
Contacts
Primary ContactJaak Kals, PhD
Outcome results
None listed