NCT01872299

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
6 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

5.1 years

First QC Date

May 17, 2013

Last Update Submit

July 25, 2016

Conditions

Heart FailureType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with chronic heart failure.

    March 31, 2014

Secondary Outcomes (5)

  • Change in exercise capacity and cardiorespiratory reflex control

    March 31, 2014

  • Change of body composition and its changes over time

    March 31, 2014

  • Incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with chronic heart failure

    March 31, 2014

  • Impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms

    March 31, 2014

  • Changes of metabolic status in patients with heart failure and type 2 diabetes, obesity and cachexia

    March 31, 2014

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hannover Medical School

Hanover, Hannover, 30625, Germany

Location

Charité- University Medicine Berlin, Campus Virchow Klinikum

Berlin, State of Berlin, 13353, Germany

Location

IRCCS San Raffaele

Rome, Rom, 00163, Italy

Location

Wroclaw, Medical University

Wroclaw, Wroclaw, 50-367, Poland

Location

Silesian Centre for Heart Diseases

Zabrze, Zabrze, 41800, Poland

Location

Russian Cardiology Research and Production Complex

Moscow, Moscow, 12552, Russia

Location

Lomonosov Moscow State University

Moscow, Moskow, 119192, Russia

Location

Almazov Federal Center for Heart, Blood & Endocrinology

Saint Petersburg, Sankt-Peterburg, 197341, Russia

Location

Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences

Tomsk, Tomsk Oblast, 634012, Russia

Location

University Clinic of Respiratory and Allergic diseases Golnik

Golnik, Golnik, 4204, Slovenia

Location

University of HULL

Hull, Hull, HU16 5JQ, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 21475696BACKGROUND

  • 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.

    PMID: 30160804DERIVED

  • 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.

    PMID: 26006717DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, DNA, biopsies from fat and muscle.

MeSH Terms

Conditions

Heart FailureDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Stefan D Anker, MD, PhD

    Charité- University Medicine Berlin, Campus Virchow Klinikum

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 17, 2013

First Posted

June 7, 2013

Study Start

March 1, 2010

Primary Completion

April 1, 2015

Study Completion

July 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

SL(1)IT(1)DE(2)PL(2)RU(4)GB(1)