Heart FailureMAGIC-HFNCT05915364
MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY
An observational study of Heart Failure, run by University of Catanzaro at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll patients referred to the outpatient heart failure clinic of the Geriatrics Units of Mater Domini Hospital
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Magna Graecia Mater Domini Hospital
Catanzaro, Calabria, 88100
Angela Sciacqua, MD
About this 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
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- heart failure, biomarkers, cardiovascular complications, Prevention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HF patients | Adult subjects with all forms of HF will be recruited |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 6 months
Determination of intimal media thickness
Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Assessment of endothelial function
Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT
Measured: 6 months
Pulse Wave velocity assessment
Evaluation of carotid-femoral pulse wave velocity by SphygmoCor
Measured: 6 months
Determination of lipopolysaccharide
Evaluation of lipopolysaccharide by ELISA sandwich
Measured: 6 months
Secondary outcomes (9)
Study of functional gut microbiota
Evaluation of gut microbiota by omics methods
Measured: 6 months
Evaluation of gut microbiota
Evaluation of gut microbiota by bioinformatic methods
Measured: 6 months
Evaluation of platelets activation
Evaluation of platelets activation biomarkers by ELISA sandwich method
Measured: 6 months
Evaluation of oxidative stress
Evaluation of oxidative stress biomarkers by ELISA sandwich method
Measured: 6 months
Evaluation of inflammatory cytokines
Evaluation of inflammatory cytokines (Interleukine-6, Interleukine-1) by ELISA sandwich method
Measured: 6 months
Evaluation of endocan levels
Evaluation of values of endocan by ELISA sandwich method
Measured: 6 months
Evaluation of hepcidin
Evaluation of circulating levels of hepcidin by ELISA sandwich method
Measured: 6 months
Determination of mammalian target of rapamycin (mTOR)
Evaluation of mTOR by ELISA sandwich method
Measured: 6 months
Proteomic analysis
Proteomics evaluation for study of post-translational modifications of circulating protein by reference Peptides markers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Nov 2022
- Primary completion1 Jun 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Sciacqua, University of Catanzaro
- Investigators
- Angela Sciacqua, MD, Principal investigator, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915364
- Sponsor's protocol ID
- 304.2022
- Acronym
- MAGIC-HF
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34447992Correale 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.
PubMed 31708358Tomasoni 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.
PubMed 33277825Gentlesk 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.
PubMed 17081210Parati 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.
PubMed 27173772
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05915364
- Acronym / sponsor ID
- MAGIC-HF / 304.2022
- Conditions
- Heart Failure
- Keywords
- heart failure, biomarkers, cardiovascular complications, Prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF patients | – | –Adult subjects with all forms of HF will be recruited |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients referred to the outpatient heart failure clinic of the Geriatrics Units of Mater Domini Hospital
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
Determination of intimal media thickness
Time frame: 6 months
Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries
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).
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.
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.
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).
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.
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.
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.
Assessment of endothelial function
Time frame: 6 months
Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT
Pulse Wave velocity assessment
Time frame: 6 months
Evaluation of carotid-femoral pulse wave velocity by SphygmoCor
Determination of lipopolysaccharide
Time frame: 6 months
Evaluation of lipopolysaccharide by ELISA sandwich
9 secondary outcomes
Study of functional gut microbiota
Time frame: 6 months
Evaluation of gut microbiota
Time frame: 6 months
Evaluation of platelets activation
Time frame: 6 months
Evaluation of oxidative stress
Time frame: 6 months
Evaluation of inflammatory cytokines
Time frame: 6 months
Evaluation of endocan levels
Time frame: 6 months
Evaluation of hepcidin
Time frame: 6 months
Determination of mammalian target of rapamycin (mTOR)
Time frame: 6 months
Proteomic analysis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 31708358Correale 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.
- Background: PubMed 33277825Tomasoni 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.
- Background: PubMed 17081210Gentlesk 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.
- Background: PubMed 27173772Parati 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Sciacqua, MD principal investigator
University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Catanzaro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Sciacqua, MD (003909613694103, sciacqua@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cardiac parameters (time frame: 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05915364, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.