NCT01238731

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 11, 2010

Status Verified

November 1, 2010

Enrollment Period

Same day

First QC Date

November 10, 2010

Last Update Submit

November 10, 2010

Conditions

Persistent Severe PH After Valve Therapy

Keywords

Valve replacementpulmonary hypertensionlong term follow up

Outcome Measures

Primary Outcomes (1)

  • Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease

    > 6 months after valve therapy

Secondary Outcomes (1)

  • MACCE, all cause mortality during FU

    Within 24 months after valve therapy

Study Arms (1)

Valve replacement

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik II, University of Bonn

Bonn, 53125, Germany

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Christoph Hammerstingl, MD

CONTACT

+4922815951christoph.hammerstingl@ukb.uni-bonn.de

Dirk Skowasch, MD, PhD

CONTACT

+4922816076dirk.skowasch@ukb.uni-bonn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2011

Study Completion

March 1, 2012

Last Updated

November 11, 2010

Record last verified: 2010-11

Locations

DE(1)