MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY

University of Catanzaro500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Magna Graecia Mater Domini Hospital

Catanzaro, Calabria, Italy

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 6 months

Determination of intimal media thickness

Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries

Time frame: 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).

Time frame: 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.

Time frame: 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.

Central Contacts

Angela Sciacqua, MD

CONTACT

003909613694103 sciacqua@unicz.it

Data from ClinicalTrials.gov

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Secondary Outcomes

Study of functional gut microbiota

Evaluation of gut microbiota by omics methods

Time frame: 6 months

Evaluation of gut microbiota

Evaluation of gut microbiota by bioinformatic methods

Time frame: 6 months

Evaluation of platelets activation

Evaluation of platelets activation biomarkers by ELISA sandwich method

Time frame: 6 months

Evaluation of oxidative stress

Evaluation of oxidative stress biomarkers by ELISA sandwich method

Time frame: 6 months

Evaluation of inflammatory cytokines

Evaluation of inflammatory cytokines (Interleukine-6, Interleukine-1) by ELISA sandwich method

Time frame: 6 months

Evaluation of endocan levels

Evaluation of values of endocan by ELISA sandwich method

Time frame: 6 months

Evaluation of hepcidin

Evaluation of circulating levels of hepcidin by ELISA sandwich method

Time frame: 6 months

Determination of mammalian target of rapamycin (mTOR)

Evaluation of mTOR by ELISA sandwich method

Time frame: 6 months

Proteomic analysis

Proteomics evaluation for study of post-translational modifications of circulating protein by reference Peptides markers

Time frame: 6 months