Clinical trial NCT01230294: New Echocardiographic Methods for Right Ventricular Function.
Official title: Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Right Ventricular Dysfunction
Keywords: echocardiography of the right heart
3D 4D echocardiography
strain measurement
chronic heart failure
pulmonary hypertension
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

Brief 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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3D-volumetry of the right ventricle
timeFrame: 2 years
measure: 2D strain of the right ventricle
timeFrame: 2 years
Secondary outcomes:
measure: pulmonary artery systolic pressure (PASP)
timeFrame: 2 years
measure: tricuspid annular plane systolic excursion (TAPSE)
timeFrame: 2 years
measure: tricuspid annular systolic velocity (TASV)
timeFrame: 2 years
measure: Tei-index (myocardial performance index)
timeFrame: 2 years
measure: LV-eccentricity-index (Lei-index)
timeFrame: 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden-Wuerttemberg
Study officials:
affiliation: Heidelberg University
name: Sebastian Greiner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Derliz Mereles, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.