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

June 21, 2023 updated by: Angela Sciacqua, University of Catanzaro

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Recruiting
        • University Magna Graecia Mater Domini Hospital
        • Contact:
          • Angela Sciacqua, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HF patients
Adult subjects with all forms of HF will be recruited

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of cardiac parameters
Time Frame: 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)
6 months
Spekle-tracking Imaging
Time Frame: 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)
6 months
Determination of intimal media thickness
Time Frame: 6 months
Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries
6 months
MiniMental State examination
Time Frame: 6 months
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
Time Frame: 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.
6 months
Montreal Cognitive Assessment
Time Frame: 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.
6 months
Evaluation of autonomy in daily activities
Time Frame: 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).
6 months
Autonomy in instrumental activities of daily living
Time Frame: 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.
6 months
Short Performance Physical battery
Time Frame: 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.
6 months
Sarcopenia
Time Frame: 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.
6 months
Assessment of endothelial function
Time Frame: 6 months
Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT
6 months
Pulse Wave velocity assessment
Time Frame: 6 months
Evaluation of carotid-femoral pulse wave velocity by SphygmoCor
6 months
Determination of lipopolysaccharide
Time Frame: 6 months
Evaluation of lipopolysaccharide by ELISA sandwich
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study of functional gut microbiota
Time Frame: 6 months
Evaluation of gut microbiota by omics methods
6 months
Evaluation of gut microbiota
Time Frame: 6 months
Evaluation of gut microbiota by bioinformatic methods
6 months
Evaluation of platelets activation
Time Frame: 6 months
Evaluation of platelets activation biomarkers by ELISA sandwich method
6 months
Evaluation of oxidative stress
Time Frame: 6 months
Evaluation of oxidative stress biomarkers by ELISA sandwich method
6 months
Evaluation of inflammatory cytokines
Time Frame: 6 months
Evaluation of inflammatory cytokines (Interleukine-6, Interleukine-1) by ELISA sandwich method
6 months
Evaluation of endocan levels
Time Frame: 6 months
Evaluation of values of endocan by ELISA sandwich method
6 months
Evaluation of hepcidin
Time Frame: 6 months
Evaluation of circulating levels of hepcidin by ELISA sandwich method
6 months
Determination of mammalian target of rapamycin (mTOR)
Time Frame: 6 months
Evaluation of mTOR by ELISA sandwich method
6 months
Proteomic analysis
Time Frame: 6 months
Proteomics evaluation for study of post-translational modifications of circulating protein by reference Peptides markers
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Investigators

  • Principal Investigator: Angela Sciacqua, MD, University of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 304.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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