NCT00976625

Brief Summary

Follow-up study in patients with severe aortic regurgitation after successful valve replacement. Systolic and diastolic function were assessed and persistent diastolic dysfunction was observed late (7-10 years) after operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 1996

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
Last Updated

September 14, 2009

Status Verified

September 1, 2009

Enrollment Period

10.9 years

First QC Date

September 11, 2009

Last Update Submit

September 11, 2009

Conditions

Aortic Regurgitation

Keywords

diastolic functionaortic regurgitationaortic valve replacementleft ventricular hypertrophymyocardial structureLV remodelingMuscular regressionLV fibrous tissue

Outcome Measures

Primary Outcomes (1)

  • Cardiac function and structure

    7-10 years

Secondary Outcomes (1)

  • LV hypertrophy and passive elastic properties

    7-10 years

Study Arms (2)

1

NO INTERVENTION

Control group without intervention. Treatment group with aortic valve replacement.

2

OTHER
Procedure: Aortic Valve Replacement

Interventions

Aortic Valve ReplacementPROCEDURE

Surgical valve replacement of the aorta

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe aortic regurgitation
  • Successful valve replacement
  • Informed consent
  • Sinus rhythm
  • No comorbidities
  • No bundle branch block
  • No pregnancy

You may not qualify if:

  • Unwillingness to undergo postop. cath
  • diabetes mellitus
  • arterial hypertension
  • bleeding disorder
  • pulmonary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Villari B, Sossalla S, Ciampi Q, Petruzziello B, Turina J, Schneider J, Turina M, Hess OM. Persistent diastolic dysfunction late after valve replacement in severe aortic regurgitation. Circulation. 2009 Dec 8;120(23):2386-92. doi: 10.1161/CIRCULATIONAHA.108.812685. Epub 2009 Nov 23.

    PMID: 19933939DERIVED

MeSH Terms

Conditions

Aortic Valve InsufficiencyHypertrophy, Left Ventricular

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesCardiomegalyHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Hess

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

January 1, 1996

Primary Completion

December 1, 2006

Study Completion

December 1, 2007

Last Updated

September 14, 2009

Record last verified: 2009-09

Locations

CH(1)