NCT03105934

Brief Summary

To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

April 4, 2017

Last Update Submit

February 9, 2018

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Image measurements

    Repeat acquisitions to be made in the same regions and in locations

    12 months

Study Arms (1)

Pulmonary Arterial Hypertension

EXPERIMENTAL

Patients with Pulmonary Arterial Hypertension

Procedure: Patients with Pulmonary Arterial Hypertension

Interventions

Patients with Pulmonary Arterial HypertensionPROCEDURE

2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.

Pulmonary Arterial Hypertension

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
  • With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines

You may not qualify if:

  • That according to investigator criteria cannot participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

hydralazine 4-anisaldehyde hydrazone

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Enric Domingo, MD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

April 1, 2016

Primary Completion

October 18, 2017

Study Completion

January 25, 2018

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

ES(1)