New Echocardiographic Methods for Right Ventricular Function. (NEW-RV)

November 5, 2016 updated by: Derliz Mereles, Heidelberg University

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 .

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

150

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

  • Germany
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • University of Heidelberg

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

Description

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

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3D-volumetry of the right ventricle
Time Frame: 2 years
2 years
2D strain of the right ventricle
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary artery systolic pressure (PASP)
Time Frame: 2 years
standard value: ≤ 30 mmHg
2 years
tricuspid annular plane systolic excursion (TAPSE)
Time Frame: 2 years
standard value: ≥ 20 mm
2 years
tricuspid annular systolic velocity (TASV)
Time Frame: 2 years
standard value: ≥ 20cm/s
2 years
Tei-index (myocardial performance index)
Time Frame: 2 years
standard value: ≥ 0,5
2 years
LV-eccentricity-index (Lei-index)
Time Frame: 2 years
standard value: ≥ 1,0
2 years

Collaborators and Investigators

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

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Sebastian Greiner, M.D., Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2010

Primary Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (ESTIMATE)

October 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 5, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S275-2010

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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