Heart Failure
Conditions
Keywords
heart failure, biomarkers, cardiovascular complications, Prevention
Brief summary
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
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.
Interventions
None listed
Sponsors
University of Catanzaro
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of lipopolysaccharide | 6 months | Evaluation of lipopolysaccharide by ELISA sandwich |
| MiniMental State examination | 6 months | Geriatric multidimensional assessment for the evaluation of MiniMental State examination (MMSE), in patients over 65 years old (range values 0-30 score). |
| Geriatric depression scale | 6 months | 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. |
| Montreal Cognitive Assessment | 6 months | 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. |
| Evaluation of autonomy in daily activities | 6 months | 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). |
| Autonomy in instrumental activities of daily living | 6 months | 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. |
| Short Performance Physical battery | 6 months | 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. |
| Sarcopenia | 6 months | Geriatric multidimensional assessment for the evaluation of Sarcopenia by SARC-f questionnaire in patients over 65 years old. Score Range 0-10 points. |
| Assessment of endothelial function | 6 months | Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT |
| Pulse Wave velocity assessment | 6 months | Evaluation of carotid-femoral pulse wave velocity by SphygmoCor |
| Determination of intimal media thickness | 6 months | Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries |
| Evaluation of cardiac parameters | 6 months | 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) |
| Spekle-tracking Imaging | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of gut microbiota | 6 months | Evaluation of gut microbiota by bioinformatic methods |
| Evaluation of platelets activation | 6 months | Evaluation of platelets activation biomarkers by ELISA sandwich method |
| Evaluation of oxidative stress | 6 months | Evaluation of oxidative stress biomarkers by ELISA sandwich method |
| Evaluation of inflammatory cytokines | 6 months | Evaluation of inflammatory cytokines (Interleukine-6, Interleukine-1) by ELISA sandwich method |
| Evaluation of endocan levels | 6 months | Evaluation of values of endocan by ELISA sandwich method |
| Evaluation of hepcidin | 6 months | Evaluation of circulating levels of hepcidin by ELISA sandwich method |
| Determination of mammalian target of rapamycin (mTOR) | 6 months | Evaluation of mTOR by ELISA sandwich method |
| Proteomic analysis | 6 months | Proteomics evaluation for study of post-translational modifications of circulating protein by reference Peptides markers |
| Study of functional gut microbiota | 6 months | Evaluation of gut microbiota by omics methods |
Countries
Italy
Contacts
Primary ContactAngela Sciacqua, MD
Outcome results
None listed