Clinical trial NCT01872299: Studies Investigating Co-morbidities Aggravating Heart Failure
Official title: Studies Investigating Co-morbidities Aggravating Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Type 2 Diabetes Mellitus
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University of Hull
name: Wroclaw Medical University
name: IRCCS San Raffaele
name: Hannover Medical School
name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
name: Moscow State University of Medicine and Dentistry
name: Siberian Branch of the Russian Academy of Medical Sciences
name: Russian Cardiology Research and Production Center
name: The University Clinic of Pulmonary and Allergic Diseases Golnik
name: Silesian Centre for Heart Diseases
First posted: 2013-06-07
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure.
timeFrame: March 31, 2014
Secondary outcomes:
measure: Change in exercise capacity and cardiorespiratory reflex control
timeFrame: March 31, 2014
measure: Change of body composition and its changes over time
timeFrame: March 31, 2014
measure: Incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with chronic heart failure
timeFrame: March 31, 2014
measure: Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms
timeFrame: March 31, 2014
measure: Changes of metabolic status in patients with heart failure and type 2 diabetes, obesity and cachexia
timeFrame: March 31, 2014
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité- University Medicine Berlin, Campus Virchow Klinikum
city: Hannover
country: Germany
facility: Hannover Medical School
city: Rom
country: Italy
facility: IRCCS San Raffaele
city: Wroclaw
country: Poland
facility: Wroclaw, Medical University
city: Zabrze
country: Poland
facility: Silesian Centre for Heart Diseases
city: Moscow
country: Russian Federation
facility: Lomonosov Moscow State University
state: Moskow
city: Moscow
country: Russian Federation
facility: Russian Cardiology Research and Production Complex
city: St. Petersburg
country: Russian Federation
facility: Almazov Federal Center for Heart, Blood & Endocrinology
city: Tomsk
country: Russian Federation
facility: Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
city: Golnik
country: Slovenia
facility: University Clinic of Respiratory and Allergic diseases Golnik
city: Hull
country: United Kingdom
facility: University of HULL
Study officials:
affiliation: Charité- University Medicine Berlin, Campus Virchow Klinikum
name: Stefan D Anker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité- University Medicine Berlin, Campus Virchow Klinikum
name: Stephan von Haehling, MD, PhD
role: STUDY_CHAIR
affiliation: University of Hull
name: John Cleland, MD, PhD
role: STUDY_CHAIR
affiliation: Wroclaw Medical University
name: Piotr Ponikowski, MD, PhD
role: STUDY_CHAIR
affiliation: IRCCS San Raffaele
name: Giuseppe Rosano, MD, PhD
role: STUDY_CHAIR
affiliation: Hannover Medical School
name: Jens Jordan, MD, PhD
role: STUDY_CHAIR
affiliation: Almazov Federal Center for Heart, Blood & Endocrinology
name: Eugeniy Shlyakhto, MD, PhD
role: STUDY_CHAIR
affiliation: Lomonosov Moscow State University
name: Vsevolod Tkachuk, MD, PhD
role: STUDY_CHAIR
affiliation: Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences
name: Rostislav Karpov, MD, PhD
role: STUDY_CHAIR
affiliation: Russian Cardiology Research and Production Complex
name: Yelena Parfyonova, MD, PhD
role: STUDY_CHAIR
affiliation: University Clinic of Respiratory and Allergic diseases Golnik
name: Mitja Lainscak, MD, PhD
role: STUDY_CHAIR
affiliation: Silesian Centre for Heart Diseases
name: Piotr Rozentryt, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Emami 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.
citation: Pellicori 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.