Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol

NCT00806390 | Terminated Phase 4 Results DMC

• 1 other identifier: HP-00040965
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate whether giving prophylactic metoprolol prior to and during anthracycline or trastuzumab therapy will decrease the incidence of anthracycline-induced cardiomyopathy. Patients are randomized to receive metoprolol or no treatment prior to anthracycline or trastuzumab treatment. The ejection fraction, as measured by nuclear ventriculography is measured before and after treatment.

Conditions

Cardiomyopathy

Keywords

ejection fraction; anthracyclines; beta-adrenergic blockade; Patients receiving anthracyclines

Outcome Measures

Primary Outcomes (1)

• Ejection Fraction by MUGA

  Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.

  Pre and post anthracycline treatment

Study Arms (2)

Metoprolol

ACTIVE COMPARATOR

Receiving metoprolol

Drug: Metoprolol

Control

NO INTERVENTION

Not receiving metoprolol

Interventions

Metoprolol DRUG

Metroprolol tartrate titrated up

Metoprolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have confirmed malignancy for which standard regimens of anthracyclines or trastuzumab are being offered as treatment at the University of Maryland Greenebaum Cancer Center. Patients must either receive 4 cycles of anthracycline for a total dose of 240 mg/m2 or six cycles of TAC for a total dose of 300 mg/m2 or trastuzumab.
• Age \> 18 years
• Ability to understand and willingness to sign a written informed consent document.
• Women of childbearing potential may participate in this study only if they have a negative pregnancy test and agree not to become pregnant during the study. Woman of childbearing potential must use an effective method of birth control such as hormonal contraceptives (oral and implant) condoms, diaphragms, spermicidal foam or jelly, surgical (hysterectomy or tubal ligation) or intrauterine device.

You may not qualify if:

• Patients who have established dilated or restrictive cardiomyopathy with EF \< 40 %.
• Patients with severe mitral or aortic valve disease (valve area \<1cm squared).
• Patients who have any contraindication to metoprolol, in particular bradycardia with HR \< 50, or severe reactive pulmonary disease such as asthma. Patients who take mibefradil or psychiatric drugs (such as phenothiazines including chlorpromazine and thioridazine) will also be excluded from the study as they have serious interactions with beta-blockers
• Patients who have untreated thyroid function disorder.
• Pregnant and nursing women are excluded from this study because of potential risk for adverse events to the fetus.
• Patients with any impediment to swallowing tablets would be excluded.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Stephen Gottlieb
• Organization: UMaryland

sgottlie@medicine.umaryland.edu

410-328-8788

Study Officials

• Stephen S Gottlieb, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 25, 2022
• Results First Posted: July 22, 2014

Record last verified: 2022-02

Locations

US (1)