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

Primary Purpose

Aortic Valve Stenosis, Pulmonary Hypertension

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Right Heart Catheterization
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Valve Stenosis focused on measuring TAVI (Transcatheter Aortic Valve Implantation), Aortic Stenosis, Pulmonary Arterial Hypertension, Right Heart Catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aortic stenosis
  • Indication of TAVI

Exclusion Criteria:

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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

No Pulmonary Arterial Hypertension before TAVI

Pulmonary Arterial Hypertension before TAVI

Arm Description

No intervention has been done in this group of patients.

In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression).

Outcomes

Primary Outcome Measures

Hospitalization for heart failure or death any cause (composite endpoint)
Time before the first event (hospitalization or death any cause)

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2019
Last Updated
August 3, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04008550
Brief Title
Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)
Acronym
HTP-TAVI
Official Title
Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Delay in enrolment (24% at 1 year) Lower than estimated prevalence of PAH (15% instead of 50%) Refusal of patients with PAH to participate
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Pulmonary Hypertension
Keywords
TAVI (Transcatheter Aortic Valve Implantation), Aortic Stenosis, Pulmonary Arterial Hypertension, Right Heart Catheterization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Pulmonary Arterial Hypertension before TAVI
Arm Type
No Intervention
Arm Description
No intervention has been done in this group of patients.
Arm Title
Pulmonary Arterial Hypertension before TAVI
Arm Type
Other
Arm Description
In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression).
Intervention Type
Procedure
Intervention Name(s)
Right Heart Catheterization
Intervention Description
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
Primary Outcome Measure Information:
Title
Hospitalization for heart failure or death any cause (composite endpoint)
Description
Time before the first event (hospitalization or death any cause)
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Post-operative evolution of the PAH, according to the type of pre-operative PAH
Description
PAPm (mean pulmonary arterial pressure) measurement
Time Frame
Year 2
Title
Prevalence of pre-TAVI PAH
Description
In percent and according to the type of PAH (pre-TAVI)
Time Frame
Year 0
Title
Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)
Description
Occurrence of clinical events
Time Frame
Year 2
Title
Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH
Description
Occurrence of clinical events
Time Frame
Month 3
Title
Concordance between the PAH measurement techniques: echocardiography and right heart catheterization
Description
PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization)
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aortic stenosis Indication of TAVI Exclusion Criteria: Contra-indication of right heart catheterization Pregnancy Persons deprived of their liberty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Durand, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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