Status:
COMPLETED
Studies Investigating Co-morbidities Aggravating Heart Failure
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
University of Hull
Wroclaw Medical University
Conditions:
Heart Failure
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT01872299
Start Date
March 1 2010
End Date
July 1 2016
Last Update
July 26 2016
Active Locations (11)
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1
Hannover Medical School
Hanover, Hannover, Germany, 30625
2
Charité- University Medicine Berlin, Campus Virchow Klinikum
Berlin, State of Berlin, Germany, 13353
3
IRCCS San Raffaele
Rome, Rom, Italy, 00163
4
Wroclaw, Medical University
Wroclaw, Wroclaw, Poland, 50-367