MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY

Study Overview
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Brief Summary
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The MAGIC-HF STUDY project (MAgna GraecIa evaluation of Comorbidities in patients with Heart Failure STUDY), is an observational prevalence and incidence study focusing on the role that risk factors, various comorbidities, and their treatment may have on CV and non-CV outcomes in patients with all forms of HF. It also aim to assess whether comorbidities and their treatment may be predictors of response to pharmacological and non-drug treatment of HF.

Detailed Description
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Adult subjects with all forms of HF (HFrEF, HFmrEf, HEpEF) with at least one comorbidity who are referred to the Heart Failure Outpatient Clinic of the AOU Mater Domini Geriatrics Unit in Catanzaro will be recruited. Initially, patients will be evaluated at baseline and followed-up for a minimum of six-month. All patients will be subjected to clinical, instrumental and laboratory examinations, including medical history data collection and complete anthropometric assessment . Plasma and serum samples will be collected at recruitment and at the six-months follow-up visit. Stool samples will also be obtained and stored at -80C for the omics studies.

Official Title
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MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY (MAGIC-HF STUDY): Observational Study on Physiopathological, Diagnostic, Therapeutic, and Predictive Aspects of Heart Failure and Associated Comorbidities

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent obtained before performing any procedure Age>18 years old Confirmed diagnosis of HFrEF, HFmrEF, HFpEF with clinical stability for at least 4 weeks Presence of at least one of the following comorbidities: Atrial fibrillation Peripheral arteriopathy Hypertension Chronic ischemic heart disease Diabetes mellitus type 2 or insulin resistance Hepatopathy Obesity Cancer Sleep apnea syndrome Chronic kidney disease Iron deficiency Cognitive Decline or Depression Sarcopenia Dysthyroidisms Hypovitaminosis D Hyperuricemia Exclusion Criteria: Liver cirrhosis Child-Pugh C Severe chronic renal failure defined by an estimated glomerular filtration rate (eGFR) value < 15 ml/min/1.73 m2 according to CKD-EPI Suspected alcohol or drug abuse Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HF patients<br>Adult subjects with all forms of HF will be recruited | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cardiac parameters | Echocardiographic evaluation of the left ventricular global system, left ventricular ejection fraction, left atrial diameter, cardiac output, cardiac index, right ventricular global function by Color-Doppler echocardiogram (Vivid E95, GE Healthcare, Horten, Norway) | 6 months | 
| Spekle-tracking Imaging | A 2D speckle tracking analysis was retrospectively performed using vendor-specific 2D speckle tracking software (EchoPAC PC, version 113.0.5, GE Healthcare, Horten, Norway). Manual tracings of the endocardial border during end-systole in three apical views was performed to evaluate GLS. echocardiogram (Vivid E95, GE Healthcare, Horten, Norway) | 6 months | 
| Determination of intimal media thickness | Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries | 6 months | 
| MiniMental State examination | Geriatric multidimensional assessment for the evaluation of MiniMental State examination (MMSE), in patients over 65 years old (range values 0-30 score). | 6 months | 
| Geriatric depression scale | Geriatric multidimensional assessment for the evaluation of Geriatric depression scale (GDS) in patients over 65 years old. The short form (GDS-S) consists of 15 items. Of the 15 elements, 10 indicate the presence of depression when responding positively, while the other five are indicative of depression when responding negatively, moreover > 5 points suggest depression and require follow-up evaluation, ≥ 10 points almost always indicates depression. | 6 months | 
| Montreal Cognitive Assessment | Geriatric multidimensional assessment for the evaluation of Montreal Cognitive Assessment (MoCA) in patients over 65 years old. This one-page 30-point test can be administered to the patient in at last 10 min. Cut-off score 26 points. | 6 months | 
| Evaluation of autonomy in daily activities | Geriatric multidimensional assessment for the evaluation of autonomy in daily activities living (ADL) in patients over 65 years old. The score ranges from 0/6 (maximum dependence) to 6/6 (maximum autonomy). | 6 months | 
| Autonomy in instrumental activities of daily living | Geriatric multidimensional assessment for the evaluation of autonomy in instrumental activities of daily living (IADL) in patients over 65 years old. Range values 0-8 points. | 6 months | 
| Short Performance Physical battery | Geriatric multidimensional assessment for the evaluation of Short Performance Physical battery (SPPB) in patients over 65 years old. The total score of the scale has a range from 0 to 12 minutes. | 6 months | 
| Sarcopenia | Geriatric multidimensional assessment for the evaluation of Sarcopenia by SARC-f questionnaire in patients over 65 years old. Score Range 0-10 points. | 6 months | 
| Assessment of endothelial function | Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT | 6 months | 
| Pulse Wave velocity assessment | Evaluation of carotid-femoral pulse wave velocity by SphygmoCor | 6 months | 
| Determination of lipopolysaccharide | Evaluation of lipopolysaccharide by ELISA sandwich | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of functional gut microbiota | Evaluation of gut microbiota by omics methods | 6 months | 
| Evaluation of gut microbiota | Evaluation of gut microbiota by bioinformatic methods | 6 months | 
| Evaluation of platelets activation | Evaluation of platelets activation biomarkers by ELISA sandwich method | 6 months | 
| Evaluation of oxidative stress | Evaluation of oxidative stress biomarkers by ELISA sandwich method | 6 months | 
| Evaluation of inflammatory cytokines | Evaluation of inflammatory cytokines (Interleukine-6, Interleukine-1) by ELISA sandwich method | 6 months | 
| Evaluation of endocan levels | Evaluation of values of endocan by ELISA sandwich method | 6 months | 
| Evaluation of hepcidin | Evaluation of circulating levels of hepcidin by ELISA sandwich method | 6 months | 
| Determination of mammalian target of rapamycin (mTOR) | Evaluation of mTOR by ELISA sandwich method | 6 months | 
| Proteomic analysis | Proteomics evaluation for study of post-translational modifications of circulating protein by reference Peptides markers | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, biomarkers, cardiovascular complications, Prevention