Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 5:41 PM
Study NCT ID:
NCT01230294
Status:
UNKNOWN
Last Update Posted:
2016-11-08
First Post:
2010-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Echocardiographic Methods for Right Ventricular Function.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-05', 'studyFirstSubmitDate': '2010-10-28', 'studyFirstSubmitQcDate': '2010-10-28', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3D-volumetry of the right ventricle', 'timeFrame': '2 years'}, {'measure': '2D strain of the right ventricle', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'pulmonary artery systolic pressure (PASP)', 'timeFrame': '2 years', 'description': 'standard value: ≤ 30 mmHg'}, {'measure': 'tricuspid annular plane systolic excursion (TAPSE)', 'timeFrame': '2 years', 'description': 'standard value: ≥ 20 mm'}, {'measure': 'tricuspid annular systolic velocity (TASV)', 'timeFrame': '2 years', 'description': 'standard value: ≥ 20cm/s'}, {'measure': 'Tei-index (myocardial performance index)', 'timeFrame': '2 years', 'description': 'standard value: ≥ 0,5'}, {'measure': 'LV-eccentricity-index (Lei-index)', 'timeFrame': '2 years', 'description': 'standard value: ≥ 1,0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['echocardiography of the right heart', '3D 4D echocardiography', 'strain measurement', 'chronic heart failure', 'pulmonary hypertension'], 'conditions': ['Right Ventricular Dysfunction']}, 'referencesModule': {'references': [{'pmid': '23208080', 'type': 'RESULT', '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.'}, {'pmid': '30245839', 'type': 'DERIVED', '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.'}, {'pmid': '24830514', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function .', 'detailedDescription': '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.\n\nMany 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.\n\nAims 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).\n\nAll participants are re-examined in constant intervals as clinically indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* patients with pulmonary aterial hypertension\n* patients with chronic heart failure of the left ventricle affecting the right heart\n* patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persons of 18 years and older who receive a transthoracic echocardiography at our department\n* written consent\n\nExclusion Criteria:\n\n* present atrial fibrillation/flutter\n* permanent pacemaker rhythm\n* moderate/severe valvular heart disease\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01230294', 'acronym': 'NEW-RV', 'briefTitle': 'New Echocardiographic Methods for Right Ventricular Function.', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.', 'orgStudyIdInfo': {'id': 'S275-2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'participants without structural heart disease'}, {'label': 'CHF', 'description': 'patients with chronic heart failure of the left ventricle affecting the right heart'}, {'label': 'PAH', 'description': 'patients with pulmonary arterial hypertension without left ventricular dysfunction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Sebastian Greiner, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}, {'name': 'Derliz Mereles, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Derliz Mereles, M.D.', 'investigatorFullName': 'Derliz Mereles', 'investigatorAffiliation': 'Heidelberg University'}}}}