Persistent Pulmonary Artery Hypertension After Valve Replacement (SALT)
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition |
|---|
|
Persistent Severe PH After Valve Therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT |
- 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 ]
- MACCE, all cause mortality during FU [ Time Frame: Within 24 months after valve therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Valve replacement
Patients undergoing valve replacement for severe valve disease will be screened for study entry
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patient with proven PH before valve replacement by right heart catherterization will be screened for study entry.
Inclusion Criteria:
- Proven pulmonary hypertension before valve replacement and informed consent for data acquisition
Exclusion Criteria:
- patients do not meet inclusion criteria
Contacts and Locations| Contact: Christoph Hammerstingl, MD | +4922815951 | christoph.hammerstingl@ukb.uni-bonn.de |
| Contact: Dirk Skowasch, MD, PhD | +4922816076 | dirk.skowasch@ukb.uni-bonn.de |
| Germany | |
| Medizinische Klinik II, University of Bonn | Not yet recruiting |
| Bonn, Germany, 53125 | |
| Contact: Robert Schueler, MD +4922815507 robert.schueler@ukb.uni-bonn.de | |
| Sub-Investigator: Stefan Pabst, MD | |
More Information
No publications provided
| Responsible Party: | Dr. Christoph Hammerstingl, Universitiy of Bonn, Medizinische Klinik und Poliklinik II |
| ClinicalTrials.gov Identifier: | NCT01238731 History of Changes |
| Other Study ID Numbers: | UKB_001_2010 |
| Study First Received: | November 10, 2010 |
| Last Updated: | November 10, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital, Bonn:
|
Valve replacement pulmonary hypertension long term follow up |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013