NCT01157572

Brief Summary

The primary objective of this study is to evaluate the effect of beta-blocker on left ventricular (LV) remodeling in asymptomatic patients with moderate to severe aortic regurgitation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

July 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

4 years

First QC Date

July 5, 2010

Last Update Submit

September 24, 2014

Conditions

Aortic Valve Insufficiency

Keywords

Aortic valve insufficiencyBeta-blocker

Outcome Measures

Primary Outcomes (1)

  • Left ventricular end-diastolic volume

    6 months

Secondary Outcomes (1)

  • Left ventricular end-systolic volume

    6 months

Study Arms (2)

Metoprolol

ACTIVE COMPARATOR
Drug: Metoprolol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MetoprololDRUG

Patients with moderate to severe aortic valve insufficiency will be randomized to Metoprolol

Metoprolol
PlaceboDRUG

Patients with moderate to severe aortic valve insufficiency will be randomized to Placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe aortic valve insufficiency
  • Asymptomatic

You may not qualify if:

  • Arrhythmia
  • Other severe valve disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Broch K, Urheim S, Lonnebakken MT, Stueflotten W, Massey R, Fossa K, Hopp E, Aakhus S, Gullestad L. Controlled release metoprolol for aortic regurgitation: a randomised clinical trial. Heart. 2016 Feb;102(3):191-7. doi: 10.1136/heartjnl-2015-308416. Epub 2015 Dec 9.

    PMID: 26661319DERIVED

MeSH Terms

Conditions

Aortic Valve Insufficiency

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 5, 2010

First Posted

July 7, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09