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

Medical University of Graz

Status: Completed

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

Treatments: Procedure: Non-invasive procedures; Radiation: Dual X-ray absorptiometry; Procedure: Ambulatory blood pressure monitoring (ABPM); Radiation: X-ray of the spine

Study type: Observational

Funder types: Other

Identifiers

NCT02922478

28-476 ex 15/16

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >= 18
2. NYHA (New York Heart Association) class II-IV symptoms
3. Left ventricular ejection fraction < 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
6. Previous diagnosis of heart failure with reduced ejection fraction defined as symptomatic left ventricular ejection < 40% requiring optimization of heart failure therapy

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)

Trial design