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

July 25, 2016 updated by: Prof. Stefan D Anker, Charite University, Berlin, Germany
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité- University Medicine Berlin, Campus Virchow Klinikum
      • Hannover, Germany, 30625
        • Hannover Medical School
  • Italy
      • Rom, Italy, 00163
        • IRCCS San Raffaele
  • Poland
      • Wroclaw, Poland, 50-367
        • Wroclaw, Medical University
      • Zabrze, Poland, 41800
        • Silesian Centre for Heart Diseases
  • Russian Federation
      • Moscow, Russian Federation, 12552
        • Russian Cardiology Research and Production Complex
      • St. Petersburg, Russian Federation, 197341
        • Almazov Federal Center for Heart, Blood & Endocrinology
      • Tomsk, Russian Federation, 634012
        • Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
    • Moskow
      • Moscow, Moskow, Russian Federation, 119192
        • Lomonosov Moscow State University
  • Slovenia
      • Golnik, Slovenia, 4204
        • University Clinic of Respiratory and Allergic Diseases Golnik
  • United Kingdom
      • Hull, United Kingdom, HU16 5JQ
        • University of Hull

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients and controls will be recruited from hospitals' outpatients' departments and/or via advertisements; in-patients are permitted if clinically stable.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Control
Healthy control subjects
Heart failure without co-morbidities
Patients with a clinical diagnosis of chronic heart failure without co-morbidities
Heart failure with co-morbidities
Patients with a clinical diagnosis of chronic heart failure with co-morbidities
Type 2 diabetes mellitus
Patients with type 2 diabetes mellitus and without heart failure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure.
Time Frame: March 31, 2014
March 31, 2014

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in exercise capacity and cardiorespiratory reflex control
Time Frame: March 31, 2014
To describe patterns of exercise capacity and cardiorespiratory reflex control
March 31, 2014
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
March 31, 2014
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
March 31, 2014
Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms
Time Frame: March 31, 2014
March 31, 2014
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
March 31, 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Hull
IRCCS San Raffaele
Hannover Medical School
Russian Cardiology Research and Production Center
Wroclaw Medical University
Moscow State University of Medicine and Dentistry
The University Clinic of Pulmonary and Allergic Diseases Golnik
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Silesian Centre for Heart Diseases
Siberian Branch of the Russian Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan D Anker, MD, PhD, Charité- University Medicine Berlin, Campus Virchow Klinikum
  • Study Chair: Stephan von Haehling, MD, PhD, Charité- University Medicine Berlin, Campus Virchow Klinikum
  • Study Chair: John Cleland, MD, PhD, University of Hull
  • Study Chair: Piotr Ponikowski, MD, PhD, Wroclaw Medical University
  • Study Chair: Giuseppe Rosano, MD, PhD, IRCCS San Raffaele
  • Study Chair: Jens Jordan, MD, PhD, Hannover Medical School
  • Study Chair: Eugeniy Shlyakhto, MD, PhD, Almazov Federal Center for Heart, Blood & Endocrinology
  • Study Chair: Vsevolod Tkachuk, MD, PhD, Lomonosov Moscow State University
  • Study Chair: Rostislav Karpov, MD, PhD, Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
  • Study Chair: Yelena Parfyonova, MD, PhD, Russian Cardiology Research and Production Complex
  • Study Chair: Mitja Lainscak, MD, PhD, University Clinic of Respiratory and Allergic Diseases Golnik
  • Study Chair: Piotr Rozentryt, MD, PhD, Silesian Centre for Heart Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FP7/2007-2013, No. 241558
  • 241558 (Other Grant/Funding Number: European Commission under the 7th Framework Programme)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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