Comparison by Transoesophageal Assessement of Systolic Right Ventricle

Clinical Trial Summary

The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.

Secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02887560
Study type	Interventional
Source	University Hospital, Strasbourg, France
Contact
Status	Completed
Phase	N/A
Start date	December 5, 2016
Completion date	February 27, 2018

Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant. — ETO VD PERIOP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms