Heart Failure, Type 2 Diabetes Mellitus
Conditions
Brief summary
SICA-HF is a prospective, multicentre, multinational, longitudinal, pathophysiological evaluation study, which is being conducted in 11 centres across six countries. SICA-HF receives funding from the European commission's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 241558 (SICA-HF) and from the Russian Ministry of Science and Education within the file transfer protocol R&D in priority fields of the S&T complex of Russia 2007-2012 under state contract number 02.527.11.0007. The aim of SICA-HF is to provide detailed characteristics of co-morbidities of heart failure at baseline and over time, particularly with regards to obesity, cachexia, and type 2 diabetes.
Detailed description
SICA-HF, consisting of outstanding European heart failure clinicians and basic researchers, has accomplished to provide a common platform for the two different research teams. All partners of SICA-HF recruited more than 1462 patients with chronic heart failure, 199 patients with type 2 diabetes without heart failure, and 173 healthy control subjects. Thus, during the last year, a cumulative 91.4% of the target value was achieved for patients with chronic heart failure, 66.3% of the target value for diabetic controls, and 115.3% and thus over-achieving for healthy subjects. The data of all participating centers were collected and entered into the central database. As of this writing, 1469 of all chronic heart failure patients' visits, 255 of diabetic controls' visits, and 167 healthy controls' visits have been entered into the online database. In total, 171 patients have been reported to be deceased; the total number of hospitalizations is 2232.
Interventions
None listed
Sponsors
University of Hull
Wroclaw Medical University
IRCCS San Raffaele
Hannover Medical School
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Moscow State University of Medicine and Dentistry
Siberian Branch of the Russian Academy of Medical Sciences
Russian Cardiology Research and Production Center
The University Clinic of Pulmonary and Allergic Diseases Golnik
Silesian Centre for Heart Diseases
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of heart failure; * Objective evidence of cardiac dysfunctions as evidenced by at least ONE of the following: * left ventricular ejection fraction ≤ 40%; * left atrial dimension \>4.0 cm (or \>2.5 cm/m in height) * NT-proBNP \>400 pg/ml \[\>47.3 pmol/l\] (or BNP \>150 pg/ml) * Current treatment with loop diuretics; * Age \>18 years; * Willingness to provide informed consent
Exclusion criteria
* Congenital heart disease; * Any life-threatening disease other than heart failure; * Active malignancy of any type, or history of a malignancy within previous 5 years; * Previous heart transplantation; * Intra-venous therapy for heart failure given within the previous 72 hours; * Severe neuro-muscular disease; * History of unstable angina, myocardial infarction or stroke within 3 months prior to the study; * Pregnancy; * Treatment with immunosuppressive therapy, e.g. steroids for rheumatoid arthritis or obstructive lung disease; * Significant renal dysfunction, defined as serum creatinine \>250 μmol/L \[\>2.8 mg/dL\]; * Severe liver disease, defined as any liver function tests \>3 times the upper limit of normal; * Unable to understand and comply with protocol or to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure. | March 31, 2014 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity and cardiorespiratory reflex control | March 31, 2014 | To describe patterns of exercise capacity and cardiorespiratory reflex control |
| Change of body composition and its changes over time | March 31, 2014 | To analyse body composition and its changes over time in patients with chronic heart failure and type 2 diabetes, obesity or cachexia |
| Incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with chronic heart failure | March 31, 2014 | — |
| Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms | March 31, 2014 | — |
| Changes of metabolic status in patients with heart failure and type 2 diabetes, obesity and cachexia | March 31, 2014 | To describe the interplay and metabolic signalling pathways between adipose tissue, skeletal muscle, the bone marrow and the heart in patients with heart |
Countries
Germany, Italy, Poland, Russia, Slovenia, United Kingdom
Outcome results
None listed