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

Medical University of Graz1 site in 1 country205 target enrollmentSeptember 2016

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Medical University of Graz
Enrollment: 205
Locations: 1
Primary Endpoint: Prevalence of vertebral fractures in chronic heart failure
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

December 20, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medical University of Graz

Responsible Party

Principal Investigator

Dirk von Lewinski

Clinical Professor

Medical University of Graz

Eligibility Criteria

Inclusion Criteria

•NYHA (New York Heart Association) class II-IV symptoms
•Left ventricular ejection fraction \< 50% at Visit
•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)