NCT01605370

Brief Summary

The purpose of this study is to evaluate if a drug called nebivolol can reverse inappropriate left ventricular mass (LVM) when compared to the standard of care drug metoprolol.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4 hypertension

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 7, 2014

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

May 22, 2012

Results QC Date

April 4, 2014

Last Update Submit

May 8, 2014

Conditions

Hypertension

Keywords

Hypertension, Left Ventricular Mass

Outcome Measures

Primary Outcomes (1)

  • Change in Inappropriate Left Ventricular Mass (LVM)

    LVM will be measured by echocardiography exam. LVM is inappropriate when observed LVM (oLVM) exceeds predicted LVM (pLVM) by more than 28%, that is, 100Ă—(oLVM/pLVM) \>128%.

    baseline, 6 months

Study Arms (2)

Nebivolol

EXPERIMENTAL

Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.

Drug: Nebivolol

Metoprolol succinate

OTHER

Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.

Drug: Metoprolol succinate

Interventions

NebivololDRUG

Nebivolol 2.5 mg once daily

Also known as: Bystolic
Nebivolol
Metoprolol succinateDRUG

Metoprolol succinate 50 mg once daily

Also known as: Toprol XL
Metoprolol succinate

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of inappropriate LVM.
  • Presence of phenotype of inappropriate LVM.

You may not qualify if:

  • The criteria will assure that only patients with hypertension are enrolled, that is, excluded will be subjects with systolic BP \< 140 or diastolic BP \< 90 (ie, prehypertension or normal BP), but without complications or any indication (or suspicion) of end-organ damage based on a physical exam, clinical history, or laboratory tests.
  • Reactive airways disease including asthma.
  • Diabetes mellitus or hypoglycemia; thyrotoxicosis.
  • LV dysfunction (ejection fraction \< 50%) or heart failure.
  • Present or previously documented coronary heart disease or angina.
  • Acute myocardial infarction, or history of myocardial infarction.
  • Severe bradycardia, heart block greater than first degree or sick sinus syndrome (unless a permanent pacemaker is in place).
  • Hepatic insufficiency or history of cirrhosis.
  • Chronic renal failure or renovascular dysfunction.
  • Cerebrovascular dysfunction.
  • Peripheral vascular disease.
  • Pregnant or nursing women; women of childbearing age will be required to take a pregnancy test at the time of enrollment and use an acceptable method of birth control.
  • Poor echo image quality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

NebivololMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenoxypropanolaminesPropanolaminesPropanols

Limitations and Caveats

The study was terminated early due to the difficulty in identifying subjects satisfying the inclusion criteria. Only 1 subject was enrolled.

Results Point of Contact

Title
Marek Belohlavek, M.D., Ph.D.
Organization
Mayo Clinic
belohlavek.marek@mayo.edu
408-301-6694

Study Officials

  • Marek Belohlavek, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 19, 2014

Results First Posted

May 7, 2014

Record last verified: 2014-05

Locations

US(1)