Role of Comorbidities in Chronic Heart Failure Study

Study Overview
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Brief Summary
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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.

Official Title
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Role of Comorbidities in Chronic Heart Failure (RoC-HF) Study

Conditions
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Heart Failure, Comorbidity, Osteoporosis, Pulse Wave Analysis, Blood Pressure Monitoring, Ambulatory, Osteoporotic Fractures

Intervention / Treatment
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* Radiation: X-ray of the spine
* Procedure: Ambulatory blood pressure monitoring (ABPM)
* Radiation: Dual X-ray absorptiometry
* Procedure: Non-invasive procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: X-ray of the spine|Every participant will undergo X-ray of the spine so that vertebral fractures can be quantified using the Genant score.|
|Procedure: Ambulatory blood pressure monitoring (ABPM)|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of osteoporosis in chronic heart failure |  | 1 day | 
| Prevalence of vertebral fractures in chronic heart failure |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral and central pulse wave velocity |  | 24 hours | 
| 24-hours systolic and diastolic blood pressure |  | 24 hours |