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Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF)

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ClinicalTrials.gov Identifier: NCT01872299
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Prof. Stefan D Anker, 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.

Condition or disease
Heart Failure Type 2 Diabetes Mellitus

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.

Study Type : Observational [Patient Registry]
Actual Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Studies Investigating Co-morbidities Aggravating Heart Failure
Study Start Date : March 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
Control
Healthy control subjects
Heart failure without co-morbidities
Patients with a clinical diagnosis of chronic heart failure without co-morbidities
Heart failure with co-morbidities
Patients with a clinical diagnosis of chronic heart failure with co-morbidities
Type 2 diabetes mellitus
Patients with type 2 diabetes mellitus and without heart failure



Primary Outcome Measures :
  1. Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure. [ Time Frame: March 31, 2014 ]

Secondary Outcome Measures :
  1. Change in exercise capacity and cardiorespiratory reflex control [ Time Frame: March 31, 2014 ]
    To describe patterns of exercise capacity and cardiorespiratory reflex control

  2. Change of body composition and its changes over time [ Time Frame: 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

  3. Incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with chronic heart failure [ Time Frame: March 31, 2014 ]
  4. Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms [ Time Frame: March 31, 2014 ]
  5. Changes of metabolic status in patients with heart failure and type 2 diabetes, obesity and cachexia [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, DNA, biopsies from fat and muscle.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients and controls will be recruited from hospitals' outpatients' departments and/or via advertisements; in-patients are permitted if clinically stable.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872299


Locations
Germany
Charité- University Medicine Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353
Hannover Medical School
Hannover, Germany, 30625
Italy
IRCCS San Raffaele
Rom, Italy, 00163
Poland
Wroclaw, Medical University
Wroclaw, Poland, 50-367
Silesian Centre for Heart Diseases
Zabrze, Poland, 41800
Russian Federation
Lomonosov Moscow State University
Moscow, Moskow, Russian Federation, 119192
Russian Cardiology Research and Production Complex
Moscow, Russian Federation, 12552
Almazov Federal Center for Heart, Blood & Endocrinology
St. Petersburg, Russian Federation, 197341
Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
Tomsk, Russian Federation, 634012
Slovenia
University Clinic of Respiratory and Allergic diseases Golnik
Golnik, Slovenia, 4204
United Kingdom
University of HULL
Hull, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Charite University, Berlin, Germany
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
Investigators
Principal Investigator: Stefan D Anker, MD, PhD Charité- University Medicine Berlin, Campus Virchow Klinikum
Study Chair: Stephan von Haehling, MD, PhD Charité- University Medicine Berlin, Campus Virchow Klinikum
Study Chair: John Cleland, MD, PhD University of Hull
Study Chair: Piotr Ponikowski, MD, PhD Wroclaw Medical University
Study Chair: Giuseppe Rosano, MD, PhD IRCCS San Raffaele
Study Chair: Jens Jordan, MD, PhD Hannover Medical School
Study Chair: Eugeniy Shlyakhto, MD, PhD Almazov Federal Center for Heart, Blood & Endocrinology
Study Chair: Vsevolod Tkachuk, MD, PhD Lomonosov Moscow State University
Study Chair: Rostislav Karpov, MD, PhD Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
Study Chair: Yelena Parfyonova, MD, PhD Russian Cardiology Research and Production Complex
Study Chair: Mitja Lainscak, MD, PhD University Clinic of Respiratory and Allergic diseases Golnik
Study Chair: Piotr Rozentryt, MD, PhD Silesian Centre for Heart Diseases

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Stefan D Anker, MD, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01872299     History of Changes
Other Study ID Numbers: FP7/2007-2013, No. 241558
241558 ( Other Grant/Funding Number: European Commission under the 7th Framework Programme )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases