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

June 21, 2019 updated by: Dirk von Lewinski, Medical University of Graz

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Stable patients with chronic heart failure

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of osteoporosis in chronic heart failure
Time Frame: 1 day
1 day
Prevalence of vertebral fractures in chronic heart failure
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Peripheral and central pulse wave velocity
Time Frame: 24 hours
24 hours
24-hours systolic and diastolic blood pressure
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Nicolas Verheyen, MD, Medical University of Graz
  • Principal Investigator: Klemens Ablasser, MD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

December 20, 2018

Study Completion (ACTUAL)

December 20, 2018

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (ESTIMATE)

October 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28-476 ex 15/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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