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Persistent Pulmonary Artery Hypertension After Valve Replacement (SALT)

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ClinicalTrials.gov Identifier: NCT01238731
Recruitment Status : Unknown
Verified November 2010 by University Hospital, Bonn.
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2010
Last Update Posted : November 11, 2010
Sponsor:
Collaborator:
Actelion Pharmaceuticals Deutschland GmbH
Information provided by:
University Hospital, Bonn

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.


Condition or disease
Persistent Severe PH After Valve Therapy

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT
Study Start Date : January 2011
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : March 2012


Group/Cohort
Valve replacement
Patients undergoing valve replacement for severe valve disease will be screened for study entry



Primary Outcome Measures :
  1. Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease [ Time Frame: > 6 months after valve therapy ]

Secondary Outcome Measures :
  1. MACCE, all cause mortality during FU [ Time Frame: Within 24 months after valve therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with proven PH before valve replacement by right heart catherterization will be screened for study entry.
Criteria

Inclusion Criteria:

  • Proven pulmonary hypertension before valve replacement and informed consent for data acquisition

Exclusion Criteria:

  • patients do not meet inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238731


Contacts
Contact: Christoph Hammerstingl, MD +4922815951 christoph.hammerstingl@ukb.uni-bonn.de
Contact: Dirk Skowasch, MD, PhD +4922816076 dirk.skowasch@ukb.uni-bonn.de

Locations
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         
Sponsors and Collaborators
University Hospital, Bonn
Actelion Pharmaceuticals Deutschland GmbH

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
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by University Hospital, Bonn:
Valve replacement
pulmonary hypertension
long term follow up

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases