Heart FailureSICA-HFNCT01872299
Studies Investigating Co-morbidities Aggravating Heart Failure
An observational study of Heart Failure and Type 2 Diabetes Mellitus, run by Charite University, Berlin, Germany at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Type 2 Diabetes Mellitus
- How many people
- 1,600 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Mar 2010to Jul 2016
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and controls will be recruited from hospitals' outpatients' departments and/or via advertisements; in-patients are permitted if clinically stable.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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 locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Russia4 sites
Lomonosov Moscow State University
Moscow, Moscow, 119192
Russian Cardiology Research and Production Complex
Moscow, Moscow, 12552
Almazov Federal Center for Heart, Blood & Endocrinology
Saint Petersburg, Sankt-Peterburg, 197341
Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
Tomsk, Tomsk Oblast, 634012
Germany2 sites
Charité- University Medicine Berlin, Campus Virchow Klinikum
Berlin, State of Berlin, 13353
Hannover Medical School
Hanover, Hannover, 30625
Poland2 sites
Wroclaw, Medical University
Wroclaw, Wroclaw, 50-367
Silesian Centre for Heart Diseases
Zabrze, Zabrze, 41800
Slovenia1 site
University Clinic of Respiratory and Allergic diseases Golnik
Golnik, Golnik, 4204
About this study
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.
Read 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 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
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure.
Measured: March 31, 2014
Secondary outcomes (5)
Change in exercise capacity and cardiorespiratory reflex control
To describe patterns of exercise capacity and cardiorespiratory reflex control
Measured: March 31, 2014
Change of body composition and its changes over time
To analyse body composition and its changes over time in patients with chronic heart failure and type 2 diabetes, obesity or cachexia
Measured: March 31, 2014
Incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with chronic heart failure
Measured: March 31, 2014
Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms
Measured: March 31, 2014
Changes of metabolic status in patients with heart failure and type 2 diabetes, obesity and cachexia
To describe the interplay and metabolic signalling pathways between adipose tissue, skeletal muscle, the bone marrow and the heart in patients with heart
Measured: March 31, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMar 2010
- Primary completionApr 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hull, Wroclaw Medical University, IRCCS San Raffaele, Hannover Medical School, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Moscow State University of Medicine and Dentistry, Siberian Branch of the Russian Academy of Medical Sciences, Russian Cardiology Research and Production Center, The University Clinic of Pulmonary and Allergic Diseases Golnik, Silesian Centre for Heart Diseases
- Responsible party
- Principal investigator, Prof. Stefan D Anker, Charite University, Berlin, Germany
- Investigators
- Stefan D Anker, MD, PhD, Principal investigator, Charité- University Medicine Berlin, Campus Virchow KlinikumStephan von Haehling, MD, PhD, Study chair, Charité- University Medicine Berlin, Campus Virchow KlinikumJohn Cleland, MD, PhD, Study chair, University of HullPiotr Ponikowski, MD, PhD, Study chair, Wroclaw Medical UniversityGiuseppe Rosano, MD, PhD, Study chair, IRCCS San RaffaeleJens Jordan, MD, PhD, Study chair, Hannover Medical SchoolEugeniy Shlyakhto, MD, PhD, Study chair, Almazov Federal Center for Heart, Blood & EndocrinologyVsevolod Tkachuk, MD, PhD, Study chair, Lomonosov Moscow State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872299
- Sponsor's protocol ID
- FP7/2007-2013, No. 241558
- Other IDs
- 241558
- Acronym
- SICA-HF
- Status last verified
- Jul 2016
- First submitted
- 17 May 2013
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21475696Emami 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.
PubMed 30160804Pellicori 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.
PubMed 26006717
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies Investigating Co-morbidities Aggravating Heart Failure
- ClinicalTrials.gov ID
- NCT01872299
- Acronym / sponsor ID
- SICA-HF / FP7/2007-2013, No. 241558
- Conditions
- Heart Failure, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Hull, Wroclaw Medical University, IRCCS San Raffaele, Hannover Medical School, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Moscow State University of Medicine and Dentistry, Siberian Branch of the Russian Academy of Medical Sciences, Russian Cardiology Research and Production Center, The University Clinic of Pulmonary and Allergic Diseases Golnik, Silesian Centre for Heart Diseases
- Study start
- Mar 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and controls will be recruited from hospitals' outpatients' departments and/or via advertisements; in-patients are permitted if clinically stable.
Key inclusion criteria (8 listed)
- Clinical diagnosis of heart failure;
- Objective evidence of cardiac dysfunctions as evidenced by at least ONE of the following:
- Current treatment with loop diuretics;
- Age >18 years;
- Willingness to provide informed consent
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure.
Time frame: March 31, 2014
5 secondary outcomes
Change in exercise capacity and cardiorespiratory reflex control
Time frame: March 31, 2014
Change of body composition and its changes over time
Time frame: 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
Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms
Time frame: March 31, 2014
Changes of metabolic status in patients with heart failure and type 2 diabetes, obesity and cachexia
Time frame: March 31, 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: PubMed 21475696von 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.
- Derived from this study: PubMed 30160804Emami 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.
- Derived from this study: PubMed 26006717Pellicori 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.
- Study home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan D Anker, MD, PhD principal investigator
Charité- University Medicine Berlin, Campus Virchow Klinikum
Stephan von Haehling, MD, PhD study chair
Charité- University Medicine Berlin, Campus Virchow Klinikum
John Cleland, MD, PhD study chair
University of Hull
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Type 2 Diabetes Mellitus, run by Charite University, Berlin, Germany at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia, Germany, Poland, Italy, Slovenia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure. (time frame: March 31, 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872299, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.