NCT02922478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

September 28, 2016

Last Update Submit

June 21, 2019

Conditions

Heart FailureComorbidityOsteoporosisPulse Wave AnalysisBlood Pressure Monitoring, AmbulatoryOsteoporotic Fractures

Outcome Measures

Primary Outcomes (2)

  • Prevalence of osteoporosis in chronic heart failure

    1 day

  • Prevalence of vertebral fractures in chronic heart failure

    1 day

Secondary Outcomes (2)

  • Peripheral and central pulse wave velocity

    24 hours

  • 24-hours systolic and diastolic blood pressure

    24 hours

Interventions

X-ray of the spineRADIATION

Every participant will undergo X-ray of the spine so that vertebral fractures can be quantified using the Genant score.

Ambulatory blood pressure monitoring (ABPM)PROCEDURE

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).

Dual X-ray absorptiometryRADIATION

Individual bone mineral density and T-Score will be determined by X-ray absorptiometry.

Non-invasive proceduresPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stable patients with chronic heart failure

You may qualify if:

  • Age \>= 18
  • NYHA (New York Heart Association) class II-IV symptoms
  • Left ventricular ejection fraction \< 50% at Visit 1.
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA plasma, serum and buffy coat will be stored at -80 °C for later determination of biomarkers and DNA sequencing.

MeSH Terms

Conditions

Heart FailureOsteoporosisOsteoporotic Fractures

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Nicolas Verheyen, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

  • Klemens Ablasser, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

AU(1)