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Chronic Heart FailureTOSCANCT02335801

The TOSCA Registry: Hormonal and Metabolic Deficiencies in Chronic Heart Failure

An observational study of Chronic Heart Failure, run by Federico II University at 17 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to determine whether the presence of metabolic alteration and anabolic deficiencies in patients with chronic heart failure are able to identify a subset of patients with poor outcome. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
How many people
650 participants
Where
17 sitesItaly
Study dates
Apr 2013to 1 Dec 2019
How long will I take part?
30 Months
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with stable chronic heart failure with reduced ejection fraction

Who may be able to join

  • patients of either sex affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
  • left ventricle ejection fraction 40% or less

Who cannot join

  • severe liver disease
  • serum creatinine levels >2.5 mg/dl
  • history of active cancer with life expectancy below 1 year
  • acute coronary syndrome in the previous 6 months

Trial locations and contacts

17 sites in 1 country.

Antonio Cittadini, Professor contact

+39 081 7464375

antonio.cittadini@unina.it

Michele Arcopinto, MD contact

+ 39 3397707531

michele.arcopinto83@gmail.com

17 sites in 1 country

Italy17 sites, 17 recruiting

  • Policlinico di Bari

    Bari

    Massimo Iacoviello, MD, massimo.iacoviello@cardio.uniba.it

    Vincenzo Triggiani, MD, v.triggiani@endo.uniba.it

    Recruiting

  • U.O. di Cardiologia 2 IRCCS-Istituto Scientifico di Riabilitazione di Cassano delle Murge

    Cassano delle Murge, Bari

    Andrea Passantino, MD, andrea.passantino@fsm.it

    Recruiting

  • Policlinico "Vittorio Emanuele" University of Catania

    Catania

    Ines Monte, MD, inemonte@unict.it

    Recruiting

  • Unità Operativa di Malattie Cardiovascolari del Policlinico Mater Domini

    Catanzaro

    Francesco Perticone, perticone@unicz.it

    Antonio Belfiore, belfiore@unicz.it

    Recruiting

  • UOC di Medicina Interna IRCCS Oasi Maria SS

    Enna

    Letizia Ragusa, MD, lragusa@oasi.en.it

    Recruiting

  • UOC Clinica Medica Dipartimento ad Attività Integrata di Medicina Azienda Ospedaliera-Universitaria S.Anna

    Ferrara

    Roberto Manfredini, MD, roberto.manfredini@unife.it

    Recruiting

  • University of Florence

    Florence

    Pietro Amedeo Modesti, MD, pamodesti@unifi.it

    Not yet recruiting

  • IRCCS Policlinico San Donato Milanese

    Milan

    Michele Arcopinto, MD, michele.arcopinto83@gmail.com

    Recruiting

  • Department of Traslational Sciences - Federico II University

    Naples, 80100

    Antonio Cittadini, MD, +39 081 7464375, antonio.cittadini@unina.it

    Michele Arcopinto, MD, +39 339 7707531, michele.arcopinto83@gmail.com

    Recruiting

  • AORN V. Monaldi SUN - Centro di diagnosi e cura Cardiomiopatie e Scompenso Cardiaco

    Naples

    Giuseppe Limongelli, MD, limongelligiuseppe@libero.it

    Recruiting

  • Dipartimento di Scienze Biomediche Avanzate Università degli studi di Napoli Federico II

    Naples

    Pasquale Perrone-Filardi, MD, pasquale.perronefilardi@unina.it

    Recruiting

  • Santa Maria della Pietà Hospital

    Nola, Napoli

    Luigi Caliendo, MD, l.caliendo@alice.it

    Luciano Carbone, MD, luciano_carbone@virgilio.it

    Recruiting

  • U.O.S. Endocrinologia Ospedali Riuniti "Villa Sofia - Cervello"

    Palermo

    Graziella Malizia, MD, graziella.malizia@alice.it

    Piernicola Garofalo, MD, piernicolagarofalo@alice.it

    Not yet recruiting

  • U.O. di Riabilitazione Cardiologica IRCCS S. Raffaele Pisana

    Rome

    Maurizio Volterrani, MD, maurizio.volterrani@sanraffaele.it

    Recruiting

  • UOC Endocrinologia e Malattie del Metabolismo Policlinico Universitario Gemelli

    Rome

    Antonio Mancini, MD, mancini.giac@mclink.it

    Recruiting

  • U.O. di Cardiologia e UTIC Ospedale S. Maria Incoronata dell'Olmo

    Salerno

    Eduardo Bossone, MD, PhD, ebossone@hotmail.com

    Francesco Ferrara, MD, francesco.ferrara30@tin.it

    Recruiting

  • Medicina Generale ad Indirizzo Endocrinologico - d.O. Azienda Ospedaliera Universitaria Integrata

    Verona

    Roberto Castello, MD, roberto.castello@ospedaleuniverona.it

    Recruiting

Other trials in Italy

About this study

Official title: The TOSCA Registry: Epidemiology, Clinical and Prognostic Value of Hormonal and Metabolic Deficiencies in Chronic Heart Failure

The objective of this study is to determine whether the presence of metabolic alteration and anabolic deficiencies in patients with chronic heart failure are able to identify a subset of patients with poor outcome.

Read the detailed description

Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.

Aim of this registry is to determine the prevalence of hormone/metabolic deficiencies in heart failure patients and to look for possible association with clinical variables. Moreover, enrolled patients will be followed up for a mean of 2,5 years in order to collect outcome data including all-cause mortality, cardiovascular mortality, hospitalizations.

This is a multi-center observational study involving several Italian Department of Cardiology, Endocrinology, Internal Medicine

Keywords
heart failure, growth hormone, testosterone, insulin resistance, thyroid hormones, survival
Medical subject headings
Heart Failure, Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all-cause mortality and hospitalization

    outcome assessed during scheduled visits or phone calls

    Measured: every six months (up to 5 years)

Secondary outcomes (2)

  1. cardiovascular mortality

    outcome assessed during scheduled visits or phone calls

    Measured: every six months (up to 5 years)

  2. cardiovascular hospitalizations

    outcome assessed during scheduled visits or phone calls

    Measured: every six months (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionJun 2015
  4. Study completion1 Dec 2019 (estimated)

Resources

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
Prospective
Enrolment
650 participants (estimated)
Target duration
30 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02335801
Sponsor's protocol ID
TOSCA0001
Acronym
TOSCA
Status last verified
Dec 2018
First submitted
9 Dec 2014
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Cittadini A, Saldamarco L, Marra AM, Arcopinto M, Carlomagno G, Imbriaco M, Del Forno D, Vigorito C, Merola B, Oliviero U, Fazio S, Sacca L. Growth hormone deficiency in patients with chronic heart failure and beneficial effects of its correction. J Clin Endocrinol Metab. 2009 Sep;94(9):3329-36. doi: 10.1210/jc.2009-0533. Epub 2009 Jul 7.

    PubMed 19584187

  • Bossone E, Limongelli G, Malizia G, Ferrara F, Vriz O, Citro R, Marra AM, Arcopinto M, Bobbio E, Sirico D, Caliendo L, Ballotta A, D'Andrea A, Frigiola A, Isgaard J, Sacca L, Antonio C; T.O.S.CA. Investigators. The T.O.S.CA. Project: research, education and care. Monaldi Arch Chest Dis. 2011 Dec;76(4):198-203. doi: 10.4081/monaldi.2011.177.

    PubMed 22567736

  • Arcopinto M, Isgaard J, Marra AM, Formisano P, Bossone E, Vriz O, Vigorito C, Sacca L, Douglas PS, Cittadini A. IGF-1 predicts survival in chronic heart failure. Insights from the T.O.S.CA. (Trattamento Ormonale Nello Scompenso CArdiaco) registry. Int J Cardiol. 2014 Oct 20;176(3):1006-8. doi: 10.1016/j.ijcard.2014.07.003. Epub 2014 Jul 11. No abstract available.

    PubMed 25037691

  • Cittadini A, Marra AM, Arcopinto M, Bobbio E, Salzano A, Sirico D, Napoli R, Colao A, Longobardi S, Baliga RR, Bossone E, Sacca L. Growth hormone replacement delays the progression of chronic heart failure combined with growth hormone deficiency: an extension of a randomized controlled single-blind study. JACC Heart Fail. 2013 Aug;1(4):325-330. doi: 10.1016/j.jchf.2013.04.003. Epub 2013 Aug 5.

    PubMed 24621936

  • Salzano A, D'Assante R, Iacoviello M, Triggiani V, Rengo G, Cacciatore F, Maiello C, Limongelli G, Masarone D, Sciacqua A, Filardi PP, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Arcopinto M, Gargiulo P, Perticone M, Colao A, Milano S, Garavaglia A, Napoli R, Suzuki T, Bossone E, Marra AM, Cittadini A; T.O.S.CA. Investigators. Progressive right ventricular dysfunction and exercise impairment in patients with heart failure and diabetes mellitus: insights from the T.O.S.CA. Registry. Cardiovasc Diabetol. 2022 Jun 16;21(1):108. doi: 10.1186/s12933-022-01543-3.

    PubMed 35710369

  • Cittadini A, Salzano A, Iacoviello M, Triggiani V, Rengo G, Cacciatore F, Maiello C, Limongelli G, Masarone D, Perticone F, Cimellaro A, Perrone Filardi P, Paolillo S, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Monte IP, Puzzo A, Ballotta A, D'Assante R, Arcopinto M, Gargiulo P, Sciacqua A, Bruzzese D, Colao A, Napoli R, Suzuki T, Eagle KA, Ventura HO, Marra AM, Bossone E; T.O.S.CA. Investigators. Multiple hormonal and metabolic deficiency syndrome predicts outcome in heart failure: the T.O.S.CA. Registry. Eur J Prev Cardiol. 2021 Dec 29;28(15):1691-1700. doi: 10.1093/eurjpc/zwab020.

    PubMed 33693736

  • Bossone E, Arcopinto M, Iacoviello M, Triggiani V, Cacciatore F, Maiello C, Limongelli G, Masarone D, Perticone F, Sciacqua A, Perrone-Filardi P, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Monte I, Puzzo A, Ballotta A, Caliendo L, D'Assante R, Marra AM, Salzano A, Suzuki T, Cittadini A; TOSCA Investigators. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry. Intern Emerg Med. 2018 Aug;13(5):661-671. doi: 10.1007/s11739-018-1844-8. Epub 2018 Apr 4.

    PubMed 29619769

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure, run by Federico II University at 17 sites 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 2 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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 Antonio Cittadini, Professor (+39 081 7464375, antonio.cittadini@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all-cause mortality and hospitalization (time frame: every six months (up to 5 years)). 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 NCT02335801, which also lists 7 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 13 Dec 2018.

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