Persistent Pulmonary Artery Hypertension After Valve Replacement (SALT)
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 10, 2010 | ||||||||
| Last Updated Date | November 10, 2010 | ||||||||
| Start Date ICMJE | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease [ Time Frame: > 6 months after valve therapy ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
MACCE, all cause mortality during FU [ Time Frame: Within 24 months after valve therapy ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Persistent Pulmonary Artery Hypertension After Valve Replacement | ||||||||
| Official Title ICMJE | Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patient with proven PH before valve replacement by right heart catherterization will be screened for study entry. |
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| Condition ICMJE | Persistent Severe PH After Valve Therapy | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Valve replacement
Patients undergoing valve replacement for severe valve disease will be screened for study entry |
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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 | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | March 2012 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01238731 | ||||||||
| Other Study ID Numbers ICMJE | UKB_001_2010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Christoph Hammerstingl, Universitiy of Bonn, Medizinische Klinik und Poliklinik II | ||||||||
| Study Sponsor ICMJE | University Hospital, Bonn | ||||||||
| Collaborators ICMJE | Actelion Pharmaceuticals Deutschland GmbH | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University Hospital, Bonn | ||||||||
| Verification Date | November 2010 | ||||||||
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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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