MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY

Heart Failure Clinical Trial

— MAGIC-HF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915364
• Other study ID #: 304.2022
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: November 2024

Study information

• Verified date: May 2023
• Source: University of Catanzaro
• Contact: Angela Sciacqua, MD
• Phone: 003909613694103
• Email: sciacqua[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	University Magna Graecia Mater Domini Hospital	Catanzaro	Calabria

Sponsors (1)

Lead Sponsor	Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. Erratum In: Eur Heart J. 2021 Oct 14;: — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Primary	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)	6 months
Primary	Determination of intimal media thickness	Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries	6 months
Primary	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).	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	Evaluation of autonomy in daily activities	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).	6 months
Primary	Autonomy in instrumental activities of daily living	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.	6 months
Primary	Short Performance Physical battery	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.	6 months
Primary	Sarcopenia	Geriatric multidimensional assessment for the evaluation of Sarcopenia by SARC-f questionnaire in patients over 65 years old. Score Range 0-10 points.	6 months
Primary	Assessment of endothelial function	Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT	6 months
Primary	Pulse Wave velocity assessment	Evaluation of carotid-femoral pulse wave velocity by SphygmoCor	6 months
Primary	Determination of lipopolysaccharide	Evaluation of lipopolysaccharide by ELISA sandwich	6 months
Secondary	Study of functional gut microbiota	Evaluation of gut microbiota by omics methods	6 months
Secondary	Evaluation of gut microbiota	Evaluation of gut microbiota by bioinformatic methods	6 months
Secondary	Evaluation of platelets activation	Evaluation of platelets activation biomarkers by ELISA sandwich method	6 months
Secondary	Evaluation of oxidative stress	Evaluation of oxidative stress biomarkers by ELISA sandwich method	6 months
Secondary	Evaluation of inflammatory cytokines	Evaluation of inflammatory cytokines (Interleukine-6, Interleukine-1) by ELISA sandwich method	6 months
Secondary	Evaluation of endocan levels	Evaluation of values of endocan by ELISA sandwich method	6 months
Secondary	Evaluation of hepcidin	Evaluation of circulating levels of hepcidin by ELISA sandwich method	6 months
Secondary	Determination of mammalian target of rapamycin (mTOR)	Evaluation of mTOR by ELISA sandwich method	6 months
Secondary	Proteomic analysis	Proteomics evaluation for study of post-translational modifications of circulating protein by reference Peptides markers	6 months