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Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI) (HTP-TAVI)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aortic Valve Stenosis Pulmonary Hypertension | Procedure: Right Heart Catheterization | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 101 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation |
| Actual Study Start Date : | March 6, 2019 |
| Actual Primary Completion Date : | March 5, 2020 |
| Actual Study Completion Date : | March 5, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: No Pulmonary Arterial Hypertension before TAVI
No intervention has been done in this group of patients.
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Pulmonary Arterial Hypertension before TAVI
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
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
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- 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)
- Post-operative evolution of the PAH, according to the type of pre-operative PAH [ Time Frame: Year 2 ]PAPm (mean pulmonary arterial pressure) measurement
- Prevalence of pre-TAVI PAH [ Time Frame: Year 0 ]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) [ Time Frame: Year 2 ]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 [ Time Frame: Month 3 ]Occurrence of clinical events
- Concordance between the PAH measurement techniques: echocardiography and right heart catheterization [ Time Frame: Month 3 ]PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aortic stenosis
- Indication of TAVI
Exclusion Criteria:
- Contra-indication of right heart catheterization
- Pregnancy
- Persons deprived of their liberty
| France | |
| Rouen University Hospital | |
| Rouen, France, 76031 | |
| Principal Investigator: | Eric Durand, MD | Rouen University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 26, 2019 | ||||
| First Posted Date ICMJE | July 5, 2019 | ||||
| Last Update Posted Date | August 5, 2020 | ||||
| Actual Study Start Date ICMJE | March 6, 2019 | ||||
| Actual Primary Completion Date | March 5, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI) | ||||
| Official Title ICMJE | Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Right Heart Catheterization
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Actual Enrollment ICMJE |
101 | ||||
| Original Estimated Enrollment ICMJE |
424 | ||||
| Actual Study Completion Date ICMJE | March 5, 2020 | ||||
| Actual Primary Completion Date | March 5, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04008550 | ||||
| Other Study ID Numbers ICMJE | 2018/093/HP | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | University Hospital, Rouen | ||||
| Study Sponsor ICMJE | University Hospital, Rouen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Rouen | ||||
| Verification Date | August 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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