Studies Investigating Co-morbidities Aggravating Heart Failure

Heart Failure Clinical Trial

— SICA-HF  

Official title:

Studies Investigating Co-morbidities Aggravating Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872299
• Other study ID #: FP7/2007-2013, No. 241558
• Secondary ID: 241558
• Status: Completed
• Phase: N/A
• First received: May 17, 2013
• Last updated: July 25, 2016
• Start date: March 2010
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: July 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Germany	Charité- University Medicine Berlin, Campus Virchow Klinikum	Berlin
Germany	Hannover Medical School	Hannover
Italy	IRCCS San Raffaele	Rom
Poland	Wroclaw, Medical University	Wroclaw
Poland	Silesian Centre for Heart Diseases	Zabrze
Russian Federation	Lomonosov Moscow State University	Moscow	Moskow
Russian Federation	Russian Cardiology Research and Production Complex	Moscow
Russian Federation	Almazov Federal Center for Heart, Blood & Endocrinology	St. Petersburg
Russian Federation	Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences	Tomsk
Slovenia	University Clinic of Respiratory and Allergic diseases Golnik	Golnik
United Kingdom	University of HULL	Hull

Sponsors (11)

Lead Sponsor

Collaborator

Charite University, Berlin, Germany

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

Countries where clinical trial is conducted

Germany,  Italy,  Poland,  Russian Federation,  Slovenia,  United Kingdom, 

References & Publications (1)

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. Epub 2010 Dec 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure.		March 31, 2014	No
Secondary	Change in exercise capacity and cardiorespiratory reflex control	To describe patterns of exercise capacity and cardiorespiratory reflex control	March 31, 2014	No
Secondary	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	No
Secondary	Incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with chronic heart failure		March 31, 2014	No
Secondary	Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms		March 31, 2014	No
Secondary	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	No

External Links

•   Study home page