Aortic Valve StenosisHTP-TAVINCT04008550
Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)
A study testing Right Heart Catheterization in people with Aortic Valve Stenosis and Pulmonary Hypertension, run by University Hospital, Rouen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Pulmonary Hypertension
- What is being tested?
- Right Heart Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2019to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aortic stenosis
- Indication of TAVI
Who cannot join
- Contra-indication of right heart catheterization
- Pregnancy
- Persons deprived of their liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation
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.
Read more
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
- Being tested
- Right Heart Catheterization
- Keywords
- TAVI (Transcatheter Aortic Valve Implantation), Aortic Stenosis, Pulmonary Arterial Hypertension, Right Heart Catheterization
- Medical subject headings
- Aortic Valve Stenosis, Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Heart CatheterizationProcedure or surgery
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Right Heart Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for heart failure or death any cause (composite endpoint)
Time before the first event (hospitalization or death any cause)
Measured: Up to 24 months
Secondary outcomes (5)
Post-operative evolution of the PAH, according to the type of pre-operative PAH
PAPm (mean pulmonary arterial pressure) measurement
Measured: Year 2
Prevalence of pre-TAVI PAH
In percent and according to the type of PAH (pre-TAVI)
Measured: Year 0
Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)
Occurrence of clinical events
Measured: Year 2
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
Measured: Month 3
Concordance between the PAH measurement techniques: echocardiography and right heart catheterization
PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Mar 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: * Delay in enrolment (24% at 1 year) * Lower than estimated prevalence of PAH (15% instead of 50%) * Refusal of patients with PAH to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Durand, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008550
- Sponsor's protocol ID
- 2018/093/HP
- Acronym
- HTP-TAVI
- Status last verified
- Aug 2020
- First submitted
- 26 Jun 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04008550
- Acronym / sponsor ID
- HTP-TAVI / 2018/093/HP
- Conditions
- Aortic Valve Stenosis, Pulmonary Hypertension
- Keywords
- TAVI (Transcatheter Aortic Valve Implantation), Aortic Stenosis, Pulmonary Arterial Hypertension, Right Heart Catheterization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: * Delay in enrolment (24% at 1 year) * Lower than estimated prevalence of PAH (15% instead of 50%) * Refusal of patients with PAH to participate
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Pulmonary Arterial Hypertension before TAVI | No intervention | –No intervention has been done in this group of patients. |
| Pulmonary Arterial Hypertension before TAVI | Other | Procedure: Right Heart CatheterizationIn this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aortic stenosis
- Indication of TAVI
Key exclusion criteria (3 listed)
- Contra-indication of right heart catheterization
- Pregnancy
- Persons deprived of their liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Heart CatheterizationA right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI) | Procedure or surgery | Pulmonary Arterial Hypertension before TAVI |
Primary outcome
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)
5 secondary outcomes
Post-operative evolution of the PAH, according to the type of pre-operative PAH
Time frame: Year 2
Prevalence of pre-TAVI PAH
Time frame: Year 0
Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)
Time frame: Year 2
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
Concordance between the PAH measurement techniques: echocardiography and right heart catheterization
Time frame: Month 3
Results and safety
The study was stopped early (reason given: * Delay in enrolment (24% at 1 year) * Lower than estimated prevalence of PAH (15% instead of 50%) * Refusal of patients with PAH to participate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Durand, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Heart Catheterization in people with Aortic Valve Stenosis and Pulmonary Hypertension, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: * Delay in enrolment (24% at 1 year) * Lower than estimated prevalence of PAH (15% instead of 50%) * Refusal of patients with PAH to participate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for heart failure or death any cause (composite endpoint) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.