Right Ventricular DysfunctionNEW-RVNCT01230294
New Echocardiographic Methods for Right Ventricular Function.
An observational study of Right Ventricular Dysfunction, run by Heidelberg University at 1 site in Germany.
Trial summary
Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Right Ventricular Dysfunction
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * patients with pulmonary aterial hypertension * patients with chronic heart failure of the left ventricle affecting the right heart * patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group)
Who may be able to join
- persons of 18 years and older who receive a transthoracic echocardiography at our department
- written consent
Who cannot join
- present atrial fibrillation/flutter
- permanent pacemaker rhythm
- moderate/severe valvular heart disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.
Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function .
Read the detailed description
Studies of the last years revealed that the right ventricular function is an important predictive value for the survival of patients with congenital heart disease, pulmonary hypertension or chronic heart failure. In 2006 the National Heart, Lung and Blood Institute has pronounced the right ventricular dysfunction including the non-invasive assessment of the right ventricular function as preferential aim of cardiovascular research.
Many parameters are used to describe right ventricular dysfunction, but none of these has a comparable significance like the left ventricular ejection fraction. Because of the limitation of each right ventricular parameter the stepwise combination of these parameters is used to describe right ventricular function what frequently results in further problems, especially in comparison of long-term controls.
Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function. The study is carried out as prospective, monocentric trial at the Department of Cardiology of the University Hospital of Heidelberg. Three different groups are set up for the assessment of the right ventricular function: patients with pulmonary arterial hypertension, patients with chronic heart failure of the left ventricle affecting the right heart and patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group).
All participants are re-examined in constant intervals as clinically indicated.
- Conditions
- Right Ventricular Dysfunction
- Keywords
- echocardiography of the right heart, 3D 4D echocardiography, strain measurement, chronic heart failure, pulmonary hypertension
- Medical subject headings
- Ventricular Dysfunction, Right, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | participants without structural heart disease | |
| CHF | patients with chronic heart failure of the left ventricle affecting the right heart | |
| PAH | patients with pulmonary arterial hypertension without left ventricular dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D-volumetry of the right ventricle
Measured: 2 years
2D strain of the right ventricle
Measured: 2 years
Secondary outcomes (5)
pulmonary artery systolic pressure (PASP)
standard value: ≤ 30 mmHg
Measured: 2 years
tricuspid annular plane systolic excursion (TAPSE)
standard value: ≥ 20 mm
Measured: 2 years
tricuspid annular systolic velocity (TASV)
standard value: ≥ 20cm/s
Measured: 2 years
Tei-index (myocardial performance index)
standard value: ≥ 0,5
Measured: 2 years
LV-eccentricity-index (Lei-index)
standard value: ≥ 1,0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derliz Mereles, Heidelberg University
- Investigators
- Sebastian Greiner, M.D., Principal investigator, Heidelberg UniversityDerliz Mereles, M.D., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230294
- Sponsor's protocol ID
- S275-2010
- Acronym
- NEW-RV
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2010
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greiner S, Andre F, Heimisch M, Hess A, Steen H, Katus HA, Mereles D. Non-invasive quantification of right ventricular systolic function by echocardiography: a new semi-automated approach. Clin Res Cardiol. 2013 Mar;102(3):229-35. doi: 10.1007/s00392-012-0528-z. Epub 2012 Dec 4.
PubMed 23208080Greiner S, Goppelt F, Aurich M, Katus HA, Mereles D. Prognostic relevance of the right ventricular myo-mechanical index (RV-MMI) in patients with precapillary pulmonary hypertension. Open Heart. 2018 Sep 12;5(2):e000903. doi: 10.1136/openhrt-2018-000903. eCollection 2018.
PubMed 30245839Greiner S, Heimisch M, Aurich M, Hess JA, Katus HA, Mereles D. Multiplane two-dimensional strain echocardiography for segmental analysis of right ventricular mechanics: new-RV study. Clin Res Cardiol. 2014 Oct;103(10):817-24. doi: 10.1007/s00392-014-0723-1. Epub 2014 May 16.
PubMed 24830514
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.
- ClinicalTrials.gov ID
- NCT01230294
- Acronym / sponsor ID
- NEW-RV / S275-2010
- Conditions
- Right Ventricular Dysfunction
- Keywords
- echocardiography of the right heart, 3D 4D echocardiography, strain measurement, chronic heart failure, pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (actual)
- First posted
- 29 Oct 2010 (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.
Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function .
Detailed description
Studies of the last years revealed that the right ventricular function is an important predictive value for the survival of patients with congenital heart disease, pulmonary hypertension or chronic heart failure. In 2006 the National Heart, Lung and Blood Institute has pronounced the right ventricular dysfunction including the non-invasive assessment of the right ventricular function as preferential aim of cardiovascular research.
Many parameters are used to describe right ventricular dysfunction, but none of these has a comparable significance like the left ventricular ejection fraction. Because of the limitation of each right ventricular parameter the stepwise combination of these parameters is used to describe right ventricular function what frequently results in further problems, especially in comparison of long-term controls.
Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function. The study is carried out as prospective, monocentric trial at the Department of Cardiology of the University Hospital of Heidelberg. Three different groups are set up for the assessment of the right ventricular function: patients with pulmonary arterial hypertension, patients with chronic heart failure of the left ventricle affecting the right heart and patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group).
All participants are re-examined in constant intervals as clinically indicated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | –participants without structural heart disease |
| CHF | – | –patients with chronic heart failure of the left ventricle affecting the right heart |
| PAH | – | –patients with pulmonary arterial hypertension without left ventricular dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * patients with pulmonary aterial hypertension * patients with chronic heart failure of the left ventricle affecting the right heart * patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group)
Key inclusion criteria (2 listed)
- persons of 18 years and older who receive a transthoracic echocardiography at our department
- written consent
Key exclusion criteria (4 listed)
- present atrial fibrillation/flutter
- permanent pacemaker rhythm
- moderate/severe valvular heart disease
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3D-volumetry of the right ventricle
Time frame: 2 years
2D strain of the right ventricle
Time frame: 2 years
5 secondary outcomes
pulmonary artery systolic pressure (PASP)
Time frame: 2 years
tricuspid annular plane systolic excursion (TAPSE)
Time frame: 2 years
tricuspid annular systolic velocity (TASV)
Time frame: 2 years
Tei-index (myocardial performance index)
Time frame: 2 years
LV-eccentricity-index (Lei-index)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Results publication: PubMed 23208080Greiner S, Andre F, Heimisch M, Hess A, Steen H, Katus HA, Mereles D. Non-invasive quantification of right ventricular systolic function by echocardiography: a new semi-automated approach. Clin Res Cardiol. 2013 Mar;102(3):229-35. doi: 10.1007/s00392-012-0528-z. Epub 2012 Dec 4.
- Derived from this study: PubMed 30245839Greiner S, Goppelt F, Aurich M, Katus HA, Mereles D. Prognostic relevance of the right ventricular myo-mechanical index (RV-MMI) in patients with precapillary pulmonary hypertension. Open Heart. 2018 Sep 12;5(2):e000903. doi: 10.1136/openhrt-2018-000903. eCollection 2018.
- Derived from this study: PubMed 24830514Greiner S, Heimisch M, Aurich M, Hess JA, Katus HA, Mereles D. Multiplane two-dimensional strain echocardiography for segmental analysis of right ventricular mechanics: new-RV study. Clin Res Cardiol. 2014 Oct;103(10):817-24. doi: 10.1007/s00392-014-0723-1. Epub 2014 May 16.
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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.
Sebastian Greiner, M.D. principal investigator
Heidelberg University
Derliz Mereles, M.D. principal investigator
Heidelberg University
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 Right Ventricular Dysfunction, run by Heidelberg University at 1 site in Germany.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Nov 2016. 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 Germany. 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?
Results are not available in the source record.
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?
3D-volumetry of the right ventricle (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT01230294, which also lists 3 linked publications.
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 8 Nov 2016.