The TOSCA Registry: Hormonal and Metabolic Deficiencies in Chronic Heart Failure
- Conditions
- Chronic Heart Failure
- Registration Number
- NCT02335801
- Lead Sponsor
- Federico II University
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 650
- patients of either sex affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
- left ventricle ejection fraction 40% or less
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method all-cause mortality and hospitalization every six months (up to 5 years) outcome assessed during scheduled visits or phone calls
- Secondary Outcome Measures
Name Time Method cardiovascular mortality every six months (up to 5 years) outcome assessed during scheduled visits or phone calls
cardiovascular hospitalizations every six months (up to 5 years) outcome assessed during scheduled visits or phone calls
Trial Locations
- Locations (17)
U.O. di Cardiologia 2 IRCCS-Istituto Scientifico di Riabilitazione di Cassano delle Murge
🇮🇹Cassano delle Murge, Bari, Italy
Policlinico di Bari
🇮🇹Bari, Italy
Unità Operativa di Malattie Cardiovascolari del Policlinico Mater Domini
🇮🇹Catanzaro, Italy
UOC Clinica Medica Dipartimento ad Attività Integrata di Medicina Azienda Ospedaliera-Universitaria S.Anna
🇮🇹Ferrara, Italy
IRCCS Policlinico San Donato Milanese
🇮🇹Milan, Italy
Department of Traslational Sciences - Federico II University
🇮🇹Naples, Italy
Medicina Generale ad Indirizzo Endocrinologico - d.O. Azienda Ospedaliera Universitaria Integrata
🇮🇹Verona, Italy
UOC di Medicina Interna IRCCS Oasi Maria SS
🇮🇹Enna, Italy
University of Florence
🇮🇹Florence, Italy
AORN V. Monaldi SUN - Centro di diagnosi e cura Cardiomiopatie e Scompenso Cardiaco
🇮🇹Napoli, Italy
U.O.S. Endocrinologia Ospedali Riuniti "Villa Sofia - Cervello"
🇮🇹Palermo, Italy
U.O. di Riabilitazione Cardiologica IRCCS S. Raffaele Pisana
🇮🇹Rome, Italy
U.O. di Cardiologia e UTIC Ospedale S. Maria Incoronata dell'Olmo
🇮🇹Salerno, Italy
Santa Maria della Pietà Hospital
🇮🇹Nola, Napoli, Italy
Policlinico "Vittorio Emanuele" University of Catania
🇮🇹Catania, Italy
Dipartimento di Scienze Biomediche Avanzate Università degli studi di Napoli Federico II
🇮🇹Napoli, Italy
UOC Endocrinologia e Malattie del Metabolismo Policlinico Universitario Gemelli
🇮🇹Rome, Italy