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NCT Number: NCT02922478

Role of Comorbidities in Chronic Heart Failure Study

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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Key information

Conditions

Heart Failure Blood Pressure Monitoring, Ambulatory Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Comorbidity Fractures, Bone Heart Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporotic Fractures Pulse Wave Analysis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

X-ray of the spine

Radiation

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 absorptiometry

Radiation

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

Non-invasive procedures

Procedure

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 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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: RoC-HF

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2016
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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