Stress Ventricular Function in Evaluating Patients With P... | NCT02647034

Studies
Stress Ventricular Function in Evaluating Patients With Pulmonary Hypertension

NCT02647034

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jan 6, 2016Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Dyspnea

Interventions

no intervention

Countries

Taiwan

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Dec 29, 2015

First Submission Date that Met QC Criteria

Jan 4, 2016

First Posted Date

Jan 6, 2016Estimated

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

Jan 4, 2016

Last Update Posted Date

Jan 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study investigated clinical parameters, laboratory data, imaging studies to evaluate patients with suspected pulmonary hypertension.

Detailed Description

Left and right ventricular ejection fraction (LV/RV EF) at rest and immediately after exercise treadmill test (ETT) were measured by nuclear medicine study in consecutively symptomatic patients with suspected pulmonary hypertension, along with other clinical variables were correlated with right heart catheterization parameters.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pulmonary hypertension		The two groups were defined by catheterization result. (no intervention)	Other: no intervention
non-pulmonary hypertension		The two groups were defined by catheterization result. (no intervention)	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	non-pulmonary hypertension pulmonary hypertension

Measure	Description	Time Frame
All-cause mortality		an average of 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients suspicious for pulmonary hypertension.

Exclusion Criteria:

pregnant, lactating, CAD history

Accepts Healthy Volunteers

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 suspicious for pulmonary hypertension

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mei-Fang Cheng, M.D.	Contact	886-2-23123456	65575	meifang@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Mei-Fang Cheng, M.D.	National Taiwan University Hospital and National Taiwan University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital and National Taiwan University College of Medicine	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided