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CompletedNCT02922478RoC-HFUpdated Jun 24, 2019

Role of Comorbidities in Chronic Heart Failure Study

An observational study in Heart Failure, Comorbidity and Osteoporosis, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-24.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
205
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 205 is above the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Stable patients with chronic heart failure

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
205 participants (actual)
Target follow-up
1 Week
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • RadiationX-ray of the spine

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

  • ProcedureAmbulatory 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).

  • RadiationDual X-ray absorptiometry

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

  • ProcedureNon-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

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What researchers measure

Primary outcomes

  1. Prevalence of osteoporosis in chronic heart failure

    Time frame: 1 day

  2. Prevalence of vertebral fractures in chronic heart failure

    Time frame: 1 day

Secondary outcomes

  1. Peripheral and central pulse wave velocity

    Time frame: 24 hours

  2. 24-hours systolic and diastolic blood pressure

    Time frame: 24 hours

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Study locations

1 site
  • Medical University of Graz
    Graz, 8010, Austria
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References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 7, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02922478
Lead sponsor
Medical University of Graz
Responsible party
Dirk von Lewinski (Clinical Professor, Medical University of Graz) — Principal investigator
First posted
Oct 4, 2016
Start date
Sep 2016
Primary completion
Dec 20, 2018
Completion
Dec 20, 2018
Last update
Jun 24, 2019

Study contacts

Nicolas Verheyen, MD
principal investigator · Medical University of Graz
Klemens Ablasser, MD
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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