Persistent Pulmonary Artery Hypertension After Valve Replacement (SALT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University Hospital, Bonn.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Actelion Pharmaceuticals Deutschland GmbH
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01238731
First received: November 10, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 July 26, 2014