Heart FailureRoC-HFNCT02922478
Role of Comorbidities in Chronic Heart Failure Study
An observational study of Heart Failure and Comorbidity, run by Medical University of Graz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Comorbidity, Osteoporosis
- What is being tested?
- X-ray of the spine, Ambulatory blood pressure monitoring (ABPM) and Dual X-ray absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 205 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2016to 20 Dec 2018
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable patients with chronic heart failure
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heart Failure, Comorbidity, Osteoporosis, Pulse Wave Analysis, Blood Pressure Monitoring, Ambulatory, Osteoporotic Fractures
- Being tested
- X-ray of the spine, Ambulatory blood pressure monitoring (ABPM), Dual X-ray absorptiometry, Non-invasive procedures
- Medical subject headings
- Heart Failure, Osteoporosis, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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 or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of osteoporosis in chronic heart failure
Measured: 1 day
Prevalence of vertebral fractures in chronic heart failure
Measured: 1 day
Secondary outcomes (2)
Peripheral and central pulse wave velocity
Measured: 24 hours
24-hours systolic and diastolic blood pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk von Lewinski, Medical University of Graz
- Investigators
- Nicolas Verheyen, MD, Principal investigator, Medical University of GrazKlemens Ablasser, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922478
- Sponsor's protocol ID
- 28-476 ex 15/16
- Acronym
- RoC-HF
- Status last verified
- Jun 2019
- First submitted
- 28 Sep 2016
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Comorbidities in Chronic Heart Failure (RoC-HF) Study
- ClinicalTrials.gov ID
- NCT02922478
- Acronym / sponsor ID
- RoC-HF / 28-476 ex 15/16
- Conditions
- Heart Failure, Comorbidity, Osteoporosis, Pulse Wave Analysis, Blood Pressure Monitoring, Ambulatory, Osteoporotic Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable patients with chronic heart failure
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-ray of the spineEvery participant will undergo X-ray of the spine so that vertebral fractures can be quantified using the Genant score. | Radiation | – |
| 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). | Procedure or surgery | – |
| Dual X-ray absorptiometryIndividual bone mineral density and T-Score will be determined by X-ray absorptiometry. | Radiation | – |
| Non-invasive proceduresOther 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 | Procedure or surgery | – |
Primary outcome
Prevalence of osteoporosis in chronic heart failure
Time frame: 1 day
Prevalence of vertebral fractures in chronic heart failure
Time frame: 1 day
2 secondary outcomes
Peripheral and central pulse wave velocity
Time frame: 24 hours
24-hours systolic and diastolic blood pressure
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Verheyen, MD principal investigator
Medical University of Graz
Klemens Ablasser, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Comorbidity, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of osteoporosis in chronic heart failure (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.