MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY

NCT05915364 | Unknown

• 1 other identifier: 304.2022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; biomarkers; cardiovascular complications; Prevention

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• Determination of intimal media thickness

  Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries

  6 months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Assessment of endothelial function

  Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT

  6 months

• Pulse Wave velocity assessment

  Evaluation of carotid-femoral pulse wave velocity by SphygmoCor

  6 months

• Determination of lipopolysaccharide

  Evaluation of lipopolysaccharide by ELISA sandwich

  6 months

Secondary Outcomes (9)

• Study of functional gut microbiota

  6 months

• Evaluation of gut microbiota

  6 months

• Evaluation of platelets activation

  6 months

• Evaluation of oxidative stress

  6 months

• Evaluation of inflammatory cytokines

  6 months

Study Arms (1)

HF patients

Adult subjects with all forms of HF will be recruited

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University Magna Graecia Mater Domini Hospital

Catanzaro, Calabria, 88100, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 34447992 BACKGROUND

• 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.

  PMID: 31708358 BACKGROUND

• 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.

  PMID: 33277825 BACKGROUND

• 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.

  PMID: 17081210 BACKGROUND

• 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.

  PMID: 27173772 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples, Blood samples, Lymphocytes preparations, Stools samples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Angela Sciacqua, MD

  University of Catanzaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Sciacqua, MD

CONTACT

003909613694103; sciacqua@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 23, 2023
• Study Start: November 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-05

Locations

IT (1)