Studies Investigating Co-morbidities Aggravating Heart Failure

NCT ID: NCT01872299

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2016-07-31

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.

Conditions

Heart Failure; Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

Healthy control subjects

No interventions assigned to this group

Heart failure without co-morbidities

Patients with a clinical diagnosis of chronic heart failure without co-morbidities

No interventions assigned to this group

Heart failure with co-morbidities

Patients with a clinical diagnosis of chronic heart failure with co-morbidities

No interventions assigned to this group

Type 2 diabetes mellitus

Patients with type 2 diabetes mellitus and without heart failure

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hull

OTHER

Sponsor Role: collaborator

Wroclaw Medical University

OTHER

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

OTHER

Sponsor Role: collaborator

Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role: collaborator

Siberian Branch of the Russian Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Russian Cardiology Research and Production Center

OTHER

Sponsor Role: collaborator

The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role: collaborator

Silesian Centre for Heart Diseases

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Stefan D Anker

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan D Anker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charité- University Medicine Berlin, Campus Virchow Klinikum

Stephan von Haehling, MD, PhD

Role: STUDY_CHAIR

Charité- University Medicine Berlin, Campus Virchow Klinikum

John Cleland, MD, PhD

Role: STUDY_CHAIR

University of Hull

Piotr Ponikowski, MD, PhD

Role: STUDY_CHAIR

Wroclaw Medical University

Giuseppe Rosano, MD, PhD

Role: STUDY_CHAIR

IRCCS San Raffaele

Jens Jordan, MD, PhD

Role: STUDY_CHAIR

Hannover Medical School

Eugeniy Shlyakhto, MD, PhD

Role: STUDY_CHAIR

Almazov Federal Center for Heart, Blood & Endocrinology

Vsevolod Tkachuk, MD, PhD

Role: STUDY_CHAIR

Lomonosov Moscow State University

Rostislav Karpov, MD, PhD

Role: STUDY_CHAIR

Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences

Yelena Parfyonova, MD, PhD

Role: STUDY_CHAIR

Russian Cardiology Research and Production Complex

Mitja Lainscak, MD, PhD

Role: STUDY_CHAIR

University Clinic of Respiratory and Allergic diseases Golnik

Piotr Rozentryt, MD, PhD

Role: STUDY_CHAIR

Silesian Centre for Heart Diseases

Locations

Hannover Medical School

Hanover, Hannover, Germany

Charité- University Medicine Berlin, Campus Virchow Klinikum

Berlin, State of Berlin, Germany

IRCCS San Raffaele

Rome, Rom, Italy

Wroclaw, Medical University

Wroclaw, Wroclaw, Poland

Silesian Centre for Heart Diseases

Zabrze, Zabrze, Poland

Russian Cardiology Research and Production Complex

Moscow, Moscow, Russia

Lomonosov Moscow State University

Moscow, Moskow, Russia

Almazov Federal Center for Heart, Blood & Endocrinology

Saint Petersburg, Sankt-Peterburg, Russia

Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences

Tomsk, Tomsk Oblast, Russia

University Clinic of Respiratory and Allergic diseases Golnik

Golnik, Golnik, Slovenia

University of HULL

Hull, Hull, United Kingdom

Countries

Germany; Italy; Poland; Russia; Slovenia; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 21475696 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30160804 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26006717 (View on PubMed)

Related Links

http://www.sica-hf.com/

Study home page

Other Identifiers

241558

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FP7/2007-2013, No. 241558

Identifier Type: -

Identifier Source: org_study_id