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

Charité University Medicine Berlin

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01872299

241558 (Other Grant/Funding Number)

FP7/2007-2013, No. 241558

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,600 participants in 4 patient groups

Control

Description:

Healthy control subjects

Heart failure without co-morbidities

Description:

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

Heart failure with co-morbidities

Description:

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

Type 2 diabetes mellitus

Description:

Patients with type 2 diabetes mellitus and without heart failure