Studies Investigating Co-morbidities Aggravating Heart Failure
- Conditions
- Heart FailureType 2 Diabetes Mellitus
- Registration Number
- NCT01872299
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure. March 31, 2014
- Secondary Outcome Measures
Name Time Method Change in exercise capacity and cardiorespiratory reflex control March 31, 2014 To describe patterns of exercise capacity and cardiorespiratory reflex control
Incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with chronic heart failure March 31, 2014 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
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
Trial Locations
- Locations (11)
Silesian Centre for Heart Diseases
🇵🇱Zabrze, Poland
Wroclaw, Medical University
🇵🇱Wroclaw, Poland
Hannover Medical School
🇩🇪Hannover, Germany
University Clinic of Respiratory and Allergic diseases Golnik
🇸🇮Golnik, Slovenia
Russian Cardiology Research and Production Complex
🇷🇺Moscow, Russian Federation
IRCCS San Raffaele
🇮🇹Rom, Italy
Lomonosov Moscow State University
🇷🇺Moscow, Moskow, Russian Federation
Almazov Federal Center for Heart, Blood & Endocrinology
🇷🇺St. Petersburg, Russian Federation
Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
🇷🇺Tomsk, Russian Federation
Charité- University Medicine Berlin, Campus Virchow Klinikum
🇩🇪Berlin, Germany
University of HULL
🇬🇧Hull, United Kingdom