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

NCT04008550 | Terminated

• 1 other identifier: 2018/093/HP
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Pulmonary Hypertension

Keywords

TAVI (Transcatheter Aortic Valve Implantation); Aortic Stenosis; Pulmonary Arterial Hypertension; Right Heart Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Post-operative evolution of the PAH, according to the type of pre-operative PAH

  Year 2

• Prevalence of pre-TAVI PAH

  Year 0

• Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)

  Year 2

• 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

Study Arms (2)

No Pulmonary Arterial Hypertension before TAVI

NO INTERVENTION

No intervention has been done in this group of patients.

Pulmonary Arterial Hypertension before TAVI

OTHER

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

Interventions

Right Heart Catheterization PROCEDURE

A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)

Pulmonary Arterial Hypertension before TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aortic stenosis
• Indication of TAVI

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Eric Durand, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start: March 6, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

FR (1)