NCT00491387

Brief Summary

This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.

Trial Health

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Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Aug 2007

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

June 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 19, 2011

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

June 21, 2007

Results QC Date

February 22, 2011

Last Update Submit

February 2, 2018

Conditions

Hypertension

Keywords

hypertensionsympathetic nervous system

Outcome Measures

Primary Outcomes (1)

  • Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio

    24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.

    january 2018

Study Arms (1)

metoprolol succinate

EXPERIMENTAL

Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.

Drug: Metoprolol Succinate

Interventions

Metoprolol SuccinateDRUG

Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.

Also known as: Toprol XL, metoprolol XR
metoprolol succinate

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker

You may not qualify if:

  • Known valvular heart disease of more than mild severity
  • Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization
  • Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50%
  • Atrial fibrillation
  • Current treatment with a β-adrenergic blocking drug or a calcium channel blocker
  • Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake
  • Participation in another research study within the prior 30 days
  • A life-limiting disease process that is likely to preclude completion of study participation
  • Pregnancy or breast feeding
  • Inability or unwillingness to provide informed consent
  • Baseline resting heart rate less than 65 beats per minute
  • Diabetes
  • Iodine allergy
  • Unwilling to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Limitations and Caveats

Early termination due to a publication in the literature suggesting potential increased cardiac mortality in hypertensive patients treated primarily with beta blockers. Did not feel that continued treatment in volunteer subjects could be justified.

Results Point of Contact

Title
Myron Gerson MD
Organization
University of Cincinnati
myron.gerson@uc.edu
5135583974

Study Officials

  • Myron C Gerson, M.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 26, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 7, 2018

Results First Posted

April 19, 2011

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share