Pulmonary Hypertension Registry Switzerland | NCT05610631

Studies
Pulmonary Hypertension Registry Switzerland

NCT05610631

Sponsor

University of Zurich

Status

Recruiting

Last Update Posted

Nov 9, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Pulmonary Hypertension

Interventions

Not provided

Countries

Switzerland

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 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 8, 2022

First Posted Date

Nov 9, 2022Actual

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 8, 2022

Last Update Posted Date

Nov 9, 2022Actual

Name	Class
Actelion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary arterial hypertension		Pulmonary arterial hypertension
PH due to left heart diseases		PH due to left heart diseases
PH due to lung disease and/or hypoxia		PH due to lung disease and/or hypoxia
Chronic thromboembolic PH		Chronic thromboembolic PH
Miscellaneous PH		Miscellaneous PH

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6-minute walking distance	6-minute walking distance	within the study duration e.g. up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
New York Heart Association functional class	New York Heart Association functional class	within the study duration e.g. up to 10 years
NTproBNP	NTproBNP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with PH

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pulmonary Hypertension (PH)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Silvia Ulrich, Prof. Dr.	Contact	+41442552220		silvia.ulrich@usz.ch

Overall Officials

Name	Affiliation	Role
Silvia Ulrich, Prof. Dr.	UniversityHospital Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Respiratory Clinic, University Hospital of Zurich	Recruiting	Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided