New Echocardiographic Methods for Right Ventricular Function.

NCT01230294 | Unknown DMC

• 1 other identifier: S275-2010
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 .

Conditions

Right Ventricular Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 3D-volumetry of the right ventricle

  2 years

• 2D strain of the right ventricle

  2 years

Secondary Outcomes (5)

• pulmonary artery systolic pressure (PASP)

  2 years

• tricuspid annular plane systolic excursion (TAPSE)

  2 years

• tricuspid annular systolic velocity (TASV)

  2 years

• Tei-index (myocardial performance index)

  2 years

• LV-eccentricity-index (Lei-index)

  2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• present atrial fibrillation/flutter
• permanent pacemaker rhythm
• moderate/severe valvular heart disease
• pregnancy

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (3)

• 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.

  PMID: 23208080 RESULT

• 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.

  PMID: 30245839 DERIVED

• 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.

  PMID: 24830514 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Right; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Sebastian Greiner, M.D.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Derliz Mereles, M.D.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Derliz Mereles, M.D.

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2015
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

DE (1)