MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY (MAGIC-HF)

University of Catanzaro

Status: Enrolling

Conditions: Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT05915364

304.2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 1 patient group

HF patients

Description:

Adult subjects with all forms of HF will be recruited