NCT00700947

Brief Summary

The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

December 26, 2007

Last Update Submit

August 10, 2018

Conditions

Heart DiseaseMitral RegurgitationHeart Valve DiseaseMitral Valve Insufficiency

Keywords

Heart DiseaseMitral RegurgitationHeart Valve DiseaseMitral Valve InsufficiencyHeart SurgeryHeart Valve Surgery

Outcome Measures

Primary Outcomes (5)

  • Change on Neurohormonal Measurements

    Change is calculated as the value at 6 months minus the value at baseline. The following neurohormones are measured: Brain type Natriuretic Peptide (BNP), tumor necrosis factor- alpha ( TNF- alpha), norepinephrine, epinephrine and plasma renin activity.

    Baseline, 6 months

  • Change in Left Ventricular Ejection Fraction

    Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess the systolic function.

    Baseline, 6 months

  • Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions

    Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling

    Baseline, 6 months

  • Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes

    Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling

    Baseline, 6 months

  • Change on Left Ventricular Mass

    Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling

    Baseline, 6 months

Secondary Outcomes (2)

  • Change on the Regurgitant Stroke Volume

    6 months

  • Change in Pulmonary Venous Systolic Flow Reversal

    Baseline, 6 months

Study Arms (3)

1

EXPERIMENTAL

Patients who are asymptomatic with normal left ventricular systolic function and who agree to be treated medically for severe primary mitral regurgitation with Beta-blocker therapy. Patients may entered into the Arm 2 (surgical treatment) later on when they develop symptoms or enlarged left ventricle or left ventricular dysfunction or wishes to have surgical treatment of severe primary mitral regurgitation.

Drug: Beta-blocker therapy (TOPROL-XL® )

2

NO INTERVENTION

Patients will be surgically treated for severe primary mitral regurgitation as a routine clinical care if they want to be treated surgically or develop symptoms or significant adverse left ventricular remodeling or left ventricular dysfunction.

3

NO INTERVENTION

Health Control includes the subjects with no remarkable past medical history and not currently taking any medications. Normal subjects will be used for comparison with patients with severe primary mitral regurgitation in term of clinical, echocardiographic and neuro-hormonal findings.

Interventions

Beta-blocker therapy (TOPROL-XL® )DRUG

Patients who are asymptomatic with normal left ventricular systolic function and wish to be medically treated for severe primary mitral regurgitation with Beta-blocker.

1

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of sever primary mitral regurgitation
  • Normal subjects

You may not qualify if:

  • Left ventricle ejection fraction of \<55% pre and post operation
  • Pregnancy or Lactation
  • Secondary mitral regurgitation due to coronary artery disease, cardiomyopathy, uncontrolled hypertension, or severe aortic stenosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27104, United States

Location

Related Publications (5)

  • Yang H, Davidson WR Jr, Chambers CE, Pae WE, Sun B, Campbell DB, Pu M. Preoperative pulmonary hypertension is associated with postoperative left ventricular dysfunction in chronic organic mitral regurgitation: an echocardiographic and hemodynamic study. J Am Soc Echocardiogr. 2006 Aug;19(8):1051-5. doi: 10.1016/j.echo.2006.03.016.

    PMID: 16880102BACKGROUND

  • Pu M, Gao Z, Li J, Sinoway L, Davidson WR Jr. Development of a new animal model of chronic mitral regurgitation in rats under transesophageal echocardiographic guidance. J Am Soc Echocardiogr. 2005 May;18(5):468-74. doi: 10.1016/j.echo.2004.10.005.

    PMID: 15891757BACKGROUND

  • Pu M, Gao Z, Pu DK, Davidson WR Jr. Effects of early, late, and long-term nonselective beta-blockade on left ventricular remodeling, function, and survival in chronic organic mitral regurgitation. Circ Heart Fail. 2013 Jul;6(4):756-62. doi: 10.1161/CIRCHEARTFAILURE.112.000196. Epub 2013 Apr 11.

    PMID: 23580745RESULT

  • Pu M, Gao Z, Zhang X, Liao D, Pu DK, Brennan T, Davidson WR Jr. Impact of mitral regurgitation on left ventricular anatomic and molecular remodeling and systolic function: implication for outcome. Am J Physiol Heart Circ Physiol. 2009 Jun;296(6):H1727-32. doi: 10.1152/ajpheart.00882.2008. Epub 2009 Mar 27.

    PMID: 19329766RESULT

  • Pu M. The frequency, impact, and management of mitral regurgitation in patients with heart failure. Curr Cardiol Rep. 2006 May;8(3):226-31. doi: 10.1007/s11886-006-0038-6.

    PMID: 17543250RESULT

MeSH Terms

Conditions

Heart DiseasesMitral Valve InsufficiencyHeart Valve Diseases

Interventions

Adrenergic beta-AntagonistsMetoprolol

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Min Pu, MD

    The Wake Forest University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

June 19, 2008

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

We currently have no plan to share participant data.

Locations

US(1)