Persistent Pulmonary Artery Hypertension After Valve Replacement

Persistent Severe PH After Valve Therapy Clinical Trial

— SALT  

Official title:

Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01238731
• Other study ID #: UKB_001_2010
• Status: Not yet recruiting
• Phase: N/A
• First received: November 10, 2010
• Last updated: November 10, 2010
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2010
• Source: University Hospital, Bonn
• Contact: Christoph Hammerstingl, MD
• Phone: +4922815951
• Email: christoph.hammerstingl[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients do not meet inclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Persistent Severe PH After Valve Therapy

Locations

Country	Name	City	State
Germany	Medizinische Klinik II, University of Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Actelion Pharmaceuticals Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease		> 6 months after valve therapy	No
Secondary	MACCE, all cause mortality during FU		Within 24 months after valve therapy	No