Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- University Hospital, Rouen
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Hospitalization for heart failure or death any cause (composite endpoint)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aortic stenosis
- •Indication of TAVI
Exclusion Criteria
- •Contra-indication of right heart catheterization
- •Pregnancy
- •Persons deprived of their liberty
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)(Year 2)
- Prevalence of pre-TAVI PAH(Year 0)
- Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH(Month 3)
- Concordance between the PAH measurement techniques: echocardiography and right heart catheterization(Month 3)
- Post-operative evolution of the PAH, according to the type of pre-operative PAH(Year 2)