New Echocardiographic Methods for Right Ventricular Function.

NCT ID: NCT01230294

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Right Ventricular Dysfunction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

echocardiography of the right heart 3D 4D echocardiography strain measurement chronic heart failure pulmonary hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

participants without structural heart disease

No interventions assigned to this group

CHF

patients with chronic heart failure of the left ventricle affecting the right heart

No interventions assigned to this group

PAH

patients with pulmonary arterial hypertension without left ventricular dysfunction

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* persons of 18 years and older who receive a transthoracic echocardiography at our department
* written consent

Exclusion Criteria

* present atrial fibrillation/flutter
* permanent pacemaker rhythm
* moderate/severe valvular heart disease
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Derliz Mereles

Derliz Mereles, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sebastian Greiner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Derliz Mereles, M.D.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23208080 (View on PubMed)

Greiner 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.

Reference Type DERIVED
PMID: 30245839 (View on PubMed)

Greiner 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.

Reference Type DERIVED
PMID: 24830514 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S275-2010

Identifier Type: -

Identifier Source: org_study_id