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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 1600

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité- University Medicine Berlin, Campus Virchow Klinikum
  • Hannover, Germany, 30625
    • Hannover Medical School
• Italy
  • Rom, Italy, 00163
    • IRCCS San Raffaele
• Poland
  • Wroclaw, Poland, 50-367
    • Wroclaw, Medical University
  • Zabrze, Poland, 41800
    • Silesian Centre for Heart Diseases
• Russian Federation
  • Moscow, Russian Federation, 12552
    • Russian Cardiology Research and Production Complex
  • St. Petersburg, Russian Federation, 197341
    • Almazov Federal Center for Heart, Blood & Endocrinology
  • Tomsk, Russian Federation, 634012
    • Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
  • Moskow
    • Moscow, Moskow, Russian Federation, 119192
      • Lomonosov Moscow State University
• Slovenia
  • Golnik, Slovenia, 4204
    • University Clinic of Respiratory and Allergic Diseases Golnik
• United Kingdom
  • Hull, United Kingdom, HU16 5JQ
    • University of Hull

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: University of Hull; IRCCS San Raffaele; Hannover Medical School; Russian Cardiology Research and Production Center; Wroclaw Medical University; Moscow State University of Medicine and Dentistry; The University Clinic of Pulmonary and Allergic Diseases Golnik; Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health; Silesian Centre for Heart Diseases; Siberian Branch of the Russian Academy of Medical Sciences
• 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 and helpful links

General Publications

• von Haehling S, Lainscak M, Doehner W, Ponikowski P, Rosano G, Jordan J, Rozentryt P, Rauchhaus M, Karpov R, Tkachuk V, Parfyonova Y, Zaritskey AY, Shlyakhto EV, Cleland JG, Anker SD. Diabetes mellitus, cachexia and obesity in heart failure: rationale and design of the Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF). J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):187-194. doi: 10.1007/s13539-010-0013-3. Epub 2010 Dec 17.
• Emami A, Saitoh M, Valentova M, Sandek A, Evertz R, Ebner N, Loncar G, Springer J, Doehner W, Lainscak M, Hasenfuss G, Anker SD, von Haehling S. Comparison of sarcopenia and cachexia in men with chronic heart failure: results from the Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF). Eur J Heart Fail. 2018 Nov;20(11):1580-1587. doi: 10.1002/ejhf.1304. Epub 2018 Aug 30.
• Pellicori P, Kallvikbacka-Bennett A, Dierckx R, Zhang J, Putzu P, Cuthbert J, Boyalla V, Shoaib A, Clark AL, Cleland JG. Prognostic significance of ultrasound-assessed jugular vein distensibility in heart failure. Heart. 2015 Jul;101(14):1149-58. doi: 10.1136/heartjnl-2015-307558. Epub 2015 May 25.

Helpful Links

• Study home page

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 17, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Heart Failure; Diabetes Mellitus, Type 2
• Other Study ID Numbers: FP7/2007-2013, No. 241558; 241558 (Other Grant/Funding Number: European Commission under the 7th Framework Programme)