Persistent Pulmonary Artery Hypertension After Valve Replacement

NCT ID: NCT01238731

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Severe PH After Valve Therapy

Keywords

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Valve replacement pulmonary hypertension long term follow up

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Valve replacement

Patients undergoing valve replacement for severe valve disease will be screened for study entry

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Proven pulmonary hypertension before valve replacement and informed consent for data acquisition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion Pharmaceuticals Deutschland GmbH

INDUSTRY

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Universitiy of Bonn, Medizinische Klinik und Poliklinik II

Locations

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Medizinische Klinik II, University of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Central Contacts

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Christoph Hammerstingl, MD

Role: CONTACT

Phone: +4922815951

Email: [email protected]

Dirk Skowasch, MD, PhD

Role: CONTACT

Phone: +4922816076

Email: [email protected]

Facility Contacts

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Robert Schueler, MD

Role: primary

Other Identifiers

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UKB_001_2010

Identifier Type: -

Identifier Source: org_study_id