Persistent Severe PH After Valve TherapySALTNCT01238731
Persistent Pulmonary Artery Hypertension After Valve Replacement
An observational study of Persistent Severe PH After Valve Therapy, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Severe PH After Valve Therapy
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Mar 2012
- Phase
- Observational
- 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
Study population: Patient with proven PH before valve replacement by right heart catherterization will be screened for study entry.
Who may be able to join
- Proven pulmonary hypertension before valve replacement and informed consent for data acquisition
Who cannot join
- patients do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik II, University of Bonn
Bonn, 53125
Robert Schueler, MD, +4922815507, robert.schueler@ukb.uni-bonn.de
Stefan Pabst, MD
About this study
Official title: Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT
Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome.
Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to identify factors predicting persistent PH.
Methods: All patients which underwent valve replacement at our institution between the years 2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH by means of right-heart catheterization will receive prospective follow-up with echocardiography. Diagnosis of persistent PH will be confirmed with right heart catheterization.
- Conditions
- Persistent Severe PH After Valve Therapy
- Keywords
- Valve replacement, pulmonary hypertension, long term follow up
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Valve replacement | Patients undergoing valve replacement for severe valve disease will be screened for study entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease
Measured: > 6 months after valve therapy
Secondary outcomes (1)
MACCE, all cause mortality during FU
Measured: Within 24 months after valve therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Severe PH After Valve TherapyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion Pharmaceuticals Deutschland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238731
- Sponsor's protocol ID
- UKB_001_2010
- Acronym
- SALT
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT
- ClinicalTrials.gov ID
- NCT01238731
- Acronym / sponsor ID
- SALT / UKB_001_2010
- Conditions
- Persistent Severe PH After Valve Therapy
- Keywords
- Valve replacement, pulmonary hypertension, long term follow up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Actelion Pharmaceuticals Deutschland GmbH
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- 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.
Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome.
Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to identify factors predicting persistent PH.
Methods: All patients which underwent valve replacement at our institution between the years 2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH by means of right-heart catheterization will receive prospective follow-up with echocardiography. Diagnosis of persistent PH will be confirmed with right heart catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valve replacement | – | –Patients undergoing valve replacement for severe valve disease will be screened for study entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with proven PH before valve replacement by right heart catherterization will be screened for study entry.
Key inclusion criteria (1 listed)
- Proven pulmonary hypertension before valve replacement and informed consent for data acquisition
Key exclusion criteria (1 listed)
- patients do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease
Time frame: > 6 months after valve therapy
1 secondary outcome
MACCE, all cause mortality during FU
Time frame: Within 24 months after valve therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Severe PH After Valve Therapy, run by University Hospital, Bonn at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Nov 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Hammerstingl, MD (+4922815951, christoph.hammerstingl@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease (time frame: > 6 months after valve therapy). 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 11 Nov 2010.