NCT03377673

Brief Summary

Pulmonary hypertension results in right ventricle dysfunction. Cardiac magnetic resonance derived RV ejection fraction is a prognostic value in this condition. Right ventricular geometry, function, morphology as well as pulmonary arterial stiffness and size may be evaluated by cardiac magnetic resonance imaging and could have great importance in evaluation of pulmonary hypertension prognosis and outcomes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

5.1 years

First QC Date

December 6, 2017

Last Update Submit

December 14, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • Right ventricle function and morphological changes in pulmonary hypertension patients during follow up

    Right ventricle function will be evaluated by CMR at base line and during follow up to find significant values for disease progression and prognosis

    2 years

  • Right ventricle function and morphological changes in pulmonary hypertension patients during follow up

    Pulmonary artery will be evaluated by CMR at base line and during follow up to find significant values for disease progression and prognosis

    2 years

  • Left ventricle function and mechanical changes in pulmonary hypertension patients during follow up

    Left ventricle function and mechanical changes will be evaluated by CMR and FT at base line and during follow up to find significant values for disease progression and prognosis

    2 years

  • Right ventricle mechanical changes in pulmonary hypertension patients during follow up

    Right ventricle function and mechanical changes will be evaluated by FT at base line and during follow up to find significant values for disease progression and prognosis

    2 years

Interventions

CMRDIAGNOSTIC_TEST

CMR is performed using a 1,5T whole-body system (Siemens Aera, Siemens Medical Solutions; Erlangen, Germany)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Precapillary pulmonary hypertesnion patients

You may qualify if:

  • Patient with diagnosed pulmonary hypertension
  • RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
  • Patients who signed study informed consent form.

You may not qualify if:

  • Coronary and valvular heart disease
  • Atrial fibrillation
  • Expressed shortness of breath
  • Claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSMU

Kaunas, LT44307, Lithuania

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Lina Padervinskiene, PhD

    LSMU

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 19, 2017

Study Start

January 1, 2012

Primary Completion

February 1, 2017

Study Completion

November 1, 2018

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations