Role of Comorbidities in Chronic Heart Failure Study

Completed

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

• Registration Number: NCT02922478
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of vertebral fractures in chronic heart failure	1 day
Prevalence of osteoporosis in chronic heart failure	1 day

Secondary Outcome Measures

Name	Time	Method
Peripheral and central pulse wave velocity	24 hours
24-hours systolic and diastolic blood pressure	24 hours

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria