This trial is active, not recruiting.

Conditions heart failure, comorbidity, osteoporosis, pulse wave analysis, blood pressure monitoring, ambulatory, osteoporotic fractures
Treatments x-ray of the spine, ambulatory blood pressure monitoring (abpm), dual x-ray absorptiometry, non-invasive procedures
Sponsor Medical University of Graz
Start date September 2016
End date September 2018
Trial size 205 participants
Trial identifier NCT02922478, 28-476 ex 15/16


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Prevalence of osteoporosis in chronic heart failure
time frame: 1 day
Prevalence of vertebral fractures in chronic heart failure
time frame: 1 day
Peripheral and central pulse wave velocity
time frame: 24 hours
24-hours systolic and diastolic blood pressure
time frame: 24 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age >= 18 2. NYHA (New York Heart Association) class II-IV symptoms 3. Chronic HFrEF (Heart failure with reduced ejection fraction)defined as left ventricular ejection < 50% at Visit 1. 4. Treatment according to current Heart Failure Guidelines of the European Society of Cardiology 5. Willingness and ability to provide signed informed consent form (ICF) prior to participation in any study-related procedures Exclusion Criteria: 1. Unplanned hospitalization within 1 month prior to the Baseline Visit. 2. Discontinuation or initiation of a pharmacologic or device treatment for HFrEF within 1 month prior to the baseline visit. 3. Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit. 4. Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit. 5. Any acute illness 6. Disease reducing life expectancy to < 1 year, except HFrEF 7. Recipient of any organ transplant 8. Primary significant valve disease (at least moderate to severe valve disease)

Additional Information

Official title Role of Comorbidities in Chronic Heart Failure (RoC-HF) Study
Principal investigator Nicolas Verheyen, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Medical University of Graz.