Studies Investigating Co-morbidities Aggravating Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Studies Investigating Co-morbidities Aggravating Heart Failure

Conditions
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Heart Failure, Type 2 Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Healthy control subjects | |
| Heart failure without co-morbidities<br>Patients with a clinical diagnosis of chronic heart failure without co-morbidities | |
| Heart failure with co-morbidities<br>Patients with a clinical diagnosis of chronic heart failure with co-morbidities | |
| Type 2 diabetes mellitus<br>Patients with type 2 diabetes mellitus and without heart failure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure. |  | March 31, 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise capacity and cardiorespiratory reflex control | To describe patterns of exercise capacity and cardiorespiratory reflex control | March 31, 2014 | 
| Change of body composition and its changes over time | To analyse body composition and its changes over time in patients with chronic heart failure and type 2 diabetes, obesity or cachexia | March 31, 2014 | 
| 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 | To describe the interplay and metabolic signalling pathways between adipose tissue, skeletal muscle, the bone marrow and the heart in patients with heart | March 31, 2014 |