Role of Comorbidities in Chronic Heart Failure Study (RoC-HF)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
This study aims to create a database of patients with stable and chronic heart failure with comprehensive assessment of bone, skeletal and vascular status. RoC-HF will facilitate cross-sectional and, eventually, longitudinal mechanistic epidemiological analyses to disentangle the role of the bone- vascular axis in chronic heart failure. Blood and urine samples will be stored to facilitate future biomarker analyses.
ABPM will be performed using the brachial, oscillometric, automated self-measurement mobil-O-Graph device (I.E.M. GmbH, Stolberg, Germany) with integrated ARCSolver®-Software (Austrian Institute of Technology Wien).
Radiation: Dual X-ray absorptiometry
Individual bone mineral density and T-Score will be determined by X-ray absorptiometry.
Procedure: Non-invasive procedures
Other non-invasive study procedures include structured patient interview, sampling of blood, buffy coat and spot urine (including biobanking), electrocardiogram, pulse wave velocity and analysis, transthoracic echocardiography, 4-meter gait speed test, hand grip test, questionnaires
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Stable patients with chronic heart failure
Age >= 18
NYHA (New York Heart Association) class II-IV symptoms
Left ventricular ejection fraction < 50% at Visit 1.
Treatment according to current Heart Failure Guidelines of the European Society of Cardiology
Willingness and ability to provide signed informed consent form (ICF) prior to participation in any study-related procedures
Previous diagnosis of heart failure with reduced ejection fraction defined as symptomatic left ventricular ejection < 40% requiring optimization of heart failure therapy
Unplanned hospitalization within 1 month prior to the Baseline Visit.
Discontinuation or initiation of a pharmacologic or device treatment for HFrEF within 1 month prior to the baseline visit.
Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
Any acute illness
Disease reducing life expectancy to < 1 year, except HFrEF
Recipient of any organ transplant
Primary significant valve disease (at least moderate to severe valve disease)