Clinical trial NCT05915364: MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: heart failure
biomarkers
cardiovascular complications
Prevention
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll patients referred to the outpatient heart failure clinic of the Geriatrics Units of Mater Domini Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of cardiac parameters
timeFrame: 6 months
measure: Spekle-tracking Imaging
timeFrame: 6 months
measure: Determination of intimal media thickness
timeFrame: 6 months
measure: MiniMental State examination
timeFrame: 6 months
measure: Geriatric depression scale
timeFrame: 6 months
measure: Montreal Cognitive Assessment
timeFrame: 6 months
measure: Evaluation of autonomy in daily activities
timeFrame: 6 months
measure: Autonomy in instrumental activities of daily living
timeFrame: 6 months
measure: Short Performance Physical battery
timeFrame: 6 months
measure: Sarcopenia
timeFrame: 6 months
measure: Assessment of endothelial function
timeFrame: 6 months
measure: Pulse Wave velocity assessment
timeFrame: 6 months
measure: Determination of lipopolysaccharide
timeFrame: 6 months
Secondary outcomes:
measure: Study of functional gut microbiota
timeFrame: 6 months
measure: Evaluation of gut microbiota
timeFrame: 6 months
measure: Evaluation of platelets activation
timeFrame: 6 months
measure: Evaluation of oxidative stress
timeFrame: 6 months
measure: Evaluation of inflammatory cytokines
timeFrame: 6 months
measure: Evaluation of endocan levels
timeFrame: 6 months
measure: Evaluation of hepcidin
timeFrame: 6 months
measure: Determination of mammalian target of rapamycin (mTOR)
timeFrame: 6 months
measure: Proteomic analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University Magna Graecia Mater Domini Hospital
state: Calabria
Study officials:
affiliation: University of Catanzaro
name: Angela Sciacqua, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
citation: Correale M, Paolillo S, Mercurio V, Limongelli G, Barilla F, Ruocco G, Palazzuoli A, Scrutinio D, Lagioia R, Lombardi C, Lupi L, Magri D, Masarone D, Pacileo G, Scicchitano P, Matteo Ciccone M, Parati G, Tocchetti CG, Nodari S. Comorbidities in chronic heart failure: An update from Italian Society of Cardiology (SIC) Working Group on Heart Failure. Eur J Intern Med. 2020 Jan;71:23-31. doi: 10.1016/j.ejim.2019.10.008. Epub 2019 Nov 8.
citation: Tomasoni D, Adamo M, Anker MS, von Haehling S, Coats AJS, Metra M. Heart failure in the last year: progress and perspective. ESC Heart Fail. 2020 Dec;7(6):3505-3530. doi: 10.1002/ehf2.13124. Epub 2020 Dec 5.
citation: Gentlesk PJ, Sauer WH, Gerstenfeld EP, Lin D, Dixit S, Zado E, Callans D, Marchlinski FE. Reversal of left ventricular dysfunction following ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2007 Jan;18(1):9-14. doi: 10.1111/j.1540-8167.2006.00653.x. Epub 2006 Nov 1.
citation: Parati G, Lombardi C, Castagna F, Mattaliano P, Filardi PP, Agostoni P; Italian Society of Cardiology (SIC) Working Group on Heart Failure members. Heart failure and sleep disorders. Nat Rev Cardiol. 2016 Jul;13(7):389-403. doi: 10.1038/nrcardio.2016.71. Epub 2016 May 12.