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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922478
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dirk von Lewinski, 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.

Condition or disease Intervention/treatment
Heart Failure Comorbidity Osteoporosis Pulse Wave Analysis Blood Pressure Monitoring, Ambulatory Osteoporotic Fractures Radiation: X-ray of the spine Procedure: Ambulatory blood pressure monitoring (ABPM) Radiation: Dual X-ray absorptiometry Procedure: Non-invasive procedures

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Study Type : Observational [Patient Registry]
Actual Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Role of Comorbidities in Chronic Heart Failure (RoC-HF) Study
Study Start Date : September 2016
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  1. Peripheral and central pulse wave velocity [ Time Frame: 24 hours ]
  2. 24-hours systolic and diastolic blood pressure [ Time Frame: 24 hours ]

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stable patients with chronic heart failure
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922478


Locations
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Austria
Medical University of Graz
Graz, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Nicolas Verheyen, MD Medical University of Graz
Principal Investigator: Klemens Ablasser, MD Medical University of Graz
  Study Documents (Full-Text)

Documents provided by Dirk von Lewinski, Medical University of Graz:

Additional Information:

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Responsible Party: Dirk von Lewinski, Clinical Professor, Medical University of Graz
ClinicalTrials.gov Identifier: NCT02922478    
Other Study ID Numbers: 28-476 ex 15/16
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoporosis
Heart Failure
Osteoporotic Fractures
Heart Diseases
Cardiovascular Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Fractures, Bone
Wounds and Injuries