New Echocardiographic Methods for Right Ventricular Funct... | NCT01230294

Studies
New Echocardiographic Methods for Right Ventricular Function.

NCT01230294

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Nov 8, 2016Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Right Ventricular Dysfunction

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Dec 2015Actual

Completion Date

Not provided

First Submitted Date

Oct 28, 2010

First Submission Date that Met QC Criteria

Oct 28, 2010

First Posted Date

Oct 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2016

Last Update Posted Date

Nov 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Derliz Mereles, Derliz Mereles, M.D., Heidelberg UniversityPrincipal Investigator

Lead Sponsor

Heidelberg UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
pulmonary artery systolic pressure (PASP)	standard value: ≤ 30 mmHg	2 years
tricuspid annular plane systolic excursion (TAPSE)	standard value: ≥ 20 mm

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian Greiner, M.D.	Heidelberg University	Principal Investigator
Derliz Mereles, M.D.	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23208080	Result	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.
30245839	Derived	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.

ID	Term
D018497	Ventricular Dysfunction, Right
D006976	Hypertension, Pulmonary

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D008171	Lung Diseases