NCT05624242

Brief Summary

Pulmonary hypertension (PH) is a pathophysiological condition defined by an increase in pulmonary arterial pressure above 20mmHg, which encompasses many very dissimilar conditions. Right ventricular function is the major determinant of survival in these patients. Currently, right ventricular function is estimated by trans-thoracic echocardiography via the measurement of standardised parameters. However, cardiac magnetic resonance imaging is now the reference technique for non-invasive quantification of volumes, mass, function of the right ventricle but can also be useful for the consideration of the pulmonary circulation. Thus, indices of function can be extracted and it plays an increasing role in the prognostic evaluation of the right heart function at diagnosis and at re-evaluation under treatment of pulmonary arterial hypertension. This work will initially focus on the assessment of right ventricular myocardial work by echocardiography and cardiac magnetic resonance imaging in comparison with invasive haemodynamic data.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 14, 2022

Last Update Submit

November 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Transplantation-free survival

    12 months

Interventions

all patients had magnetic resonance imaging at baseline and during follow-up.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population concerns patients with pulmonary arterial hypertension followed up in our centre, at diagnosis and when starting vasodilator treatment.

You may qualify if:

  • Patient with pulmonary arterial hypertension (group 1)
  • Patient with cardiac MRI, echocardiography and right heart catheterisation within 1 month of each other

You may not qualify if:

  • Patient with features of venous/capillary involvement
  • Pulmonary arterial hypertension associated with with congenital heart disease
  • Patient's decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Simon Valentin, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 22, 2022

Study Start

February 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share