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NCT Number: NCT01872299

Studies Investigating Co-morbidities Aggravating Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School, Hanover, Hannover, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • 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

Registry information

Acronym: SICA-HF

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Jun 7, 2013
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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