MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY
- Conditions
- Heart Failure
- Registration Number
- NCT05915364
- Lead Sponsor
- University of Catanzaro
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
Determination of intimal media thickness 6 months Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries
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)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).
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.
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.
Assessment of endothelial function 6 months Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT
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.
Pulse Wave velocity assessment 6 months Evaluation of carotid-femoral pulse wave velocity by SphygmoCor
Determination of lipopolysaccharide 6 months Evaluation of lipopolysaccharide by ELISA sandwich
- Secondary Outcome Measures
Name Time Method Study of functional gut microbiota 6 months Evaluation of gut microbiota by omics methods
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 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
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
Trial Locations
- Locations (1)
University Magna Graecia Mater Domini Hospital
🇮🇹Catanzaro, Calabria, Italy