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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-ray of the spine | Radiation | Every participant will undergo X-ray of the spine so that vertebral fractures can be quantified using the Genant score. | ||
| Ambulatory blood pressure monitoring (ABPM) | Procedure | 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). | ||
| Dual X-ray absorptiometry | Radiation | Individual bone mineral density and T-Score will be determined by X-ray absorptiometry. | ||
| Non-invasive procedures | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of osteoporosis in chronic heart failure | 1 day | |
| Prevalence of vertebral fractures in chronic heart failure | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral and central pulse wave velocity | 24 hours | |
| 24-hours systolic and diastolic blood pressure | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Stable patients with chronic heart failure
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Verheyen, MD | Medical University of Graz | Principal Investigator |
| Klemens Ablasser, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8010 | Austria |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2018 |
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EDTA plasma, serum and buffy coat will be stored at -80 °C for later determination of biomarkers and DNA sequencing.
| Nov 29, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D010024 | Osteoporosis |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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