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

Not Applicable

Terminated

• Conditions: Aortic Valve Stenosis; Pulmonary Hypertension
• Interventions: Procedure: Right Heart Catheterization

• Registration Number: NCT04008550
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Aortic stenosis
• Indication of TAVI

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Arterial Hypertension before TAVI	Right Heart Catheterization	In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression).

Primary Outcome Measures

Name	Time	Method
Hospitalization for heart failure or death any cause (composite endpoint)	Up to 24 months	Time before the first event (hospitalization or death any cause)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France