Persistent Pulmonary Artery Hypertension After Valve Replacement (SALT)

Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT

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.

Study Overview

• Status: Unknown
• Conditions: Persistent Severe PH After Valve Therapy

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Christoph Hammerstingl, MD; Phone Number: +4922815951; Email: christoph.hammerstingl@ukb.uni-bonn.de
• Study Contact Backup: Name: Dirk Skowasch, MD, PhD; Phone Number: +4922816076; Email: dirk.skowasch@ukb.uni-bonn.de

Study Locations

• Germany
  • Bonn, Germany, 53125
    • Medizinische Klinik II, University of Bonn
    • Contact: Robert Schueler, MD; Phone Number: +4922815507; Email: robert.schueler@ukb.uni-bonn.de
    • Sub-Investigator: Stefan Pabst, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with proven PH before valve replacement by right heart catherterization will be screened for study entry.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients do not meet inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease	> 6 months after valve therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
MACCE, all cause mortality during FU	Within 24 months after valve therapy

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Collaborators: Actelion Pharmaceuticals Deutschland GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: November 10, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Estimate): November 11, 2010
• Last Update Submitted That Met QC Criteria: November 10, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: pulmonary hypertension; long term follow up; Valve replacement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension
• Other Study ID Numbers: UKB_001_2010