Role of Comorbidities in Chronic Heart Failure Study

Heart Failure Clinical Trial

— RoC-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922478
• Other study ID #: 28-476 ex 15/16
• Status: Completed
• Start date: September 2016
• Est. completion date: December 20, 2018

Study information

• Verified date: June 2019
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of osteoporosis in chronic heart failure		1 day
Primary	Prevalence of vertebral fractures in chronic heart failure		1 day
Secondary	Peripheral and central pulse wave velocity		24 hours
Secondary	24-hours systolic and diastolic blood pressure		24 hours