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

Pulmonary Hypertension Clinical Trial

— HTP-TAVI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04008550
• Other study ID #: 2018/093/HP
• Status: Terminated
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aortic stenosis

• Indication of TAVI

Exclusion Criteria:

• Contra-indication of right heart catheterization

• Pregnancy

• Persons deprived of their liberty

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Procedure:
• Right Heart Catheterization
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization for heart failure or death any cause (composite endpoint)	Time before the first event (hospitalization or death any cause)	Up to 24 months
Secondary	Post-operative evolution of the PAH, according to the type of pre-operative PAH	PAPm (mean pulmonary arterial pressure) measurement	Year 2
Secondary	Prevalence of pre-TAVI PAH	In percent and according to the type of PAH (pre-TAVI)	Year 0
Secondary	Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)	Occurrence of clinical events	Year 2
Secondary	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	Month 3
Secondary	Concordance between the PAH measurement techniques: echocardiography and right heart catheterization	PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization)	Month 3