Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI) (HTP-TAVI)

August 3, 2020 updated by: University Hospital, Rouen

Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Several studies have shown that pulmonary arterial hypertension (PAH) was common in AS patients referred for TAVI and that it was an independent predictor of mortality after TAVI.

Currently, there is no data in the literature regarding the evolution and prognosis value of PAH measured using right heart catheterization (reference method). PAH could either regress after TAVI or continue to progress despite the treatment of valvulopathy, resulting in a refractory right heart failure that can lead to death.

The hypothesis of this study is that patients with PAH before TAVI procedure and at the 3-month follow-up visit (PAH persistence) have an increased risk of cardiovascular mortality compared to patients with no PAH at 3 months or having a significant reduction of their PAH (PAH regression).

The aim of the study is to evaluate the prognostic impact of the evolution of PAH after TAVI in 424 patients using right heart catheterization.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • ROUEN university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aortic stenosis
  • Indication of TAVI

Exclusion Criteria:

  • Contra-indication of right heart catheterization
  • Pregnancy
  • Persons deprived of their liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Pulmonary Arterial Hypertension before TAVI
No intervention has been done in this group of patients.
Other: Pulmonary Arterial Hypertension before TAVI
In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression).
Procedure: Right Heart Catheterization
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization for heart failure or death any cause (composite endpoint)
Time Frame: Up to 24 months
Time before the first event (hospitalization or death any cause)
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative evolution of the PAH, according to the type of pre-operative PAH
Time Frame: Year 2
PAPm (mean pulmonary arterial pressure) measurement
Year 2
Prevalence of pre-TAVI PAH
Time Frame: Year 0
In percent and according to the type of PAH (pre-TAVI)
Year 0
Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)
Time Frame: Year 2
Occurrence of clinical events
Year 2
Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH
Time Frame: Month 3
Occurrence of clinical events
Month 3
Concordance between the PAH measurement techniques: echocardiography and right heart catheterization
Time Frame: Month 3
PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization)
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Eric Durand, MD, ROUEN university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2019

Primary Completion (Actual)

March 5, 2020

Study Completion (Actual)

March 5, 2020

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/093/HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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