Trial Outcomes & Findings for Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol (NCT NCT00806390)

NCT ID: NCT00806390

Last Updated: 2022-02-25

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Pre and post anthracycline treatment

Results posted on

2022-02-25

Participant Flow

Participant milestones

Participant milestones
Measure
Metoprolol
Receiving metoprolol Metoprolol: Metroprolol tartrate titrated up
Control
Not receiving metoprolol
Overall Study
STARTED
7
8
Overall Study
COMPLETED
7
8
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Metoprolol
n=7 Participants
Receiving metoprolol Metoprolol: Metroprolol tartrate titrated up
Control
n=8 Participants
Not receiving metoprolol
Total
n=15 Participants
Total of all reporting groups
Age, Continuous
51 years
STANDARD_DEVIATION 11 • n=99 Participants
47 years
STANDARD_DEVIATION 8 • n=107 Participants
49 years
STANDARD_DEVIATION 10 • n=206 Participants
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=99 Participants
8 Participants
n=107 Participants
15 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
7 Participants
n=99 Participants
8 Participants
n=107 Participants
15 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
7 participants
n=99 Participants
8 participants
n=107 Participants
15 participants
n=206 Participants

PRIMARY outcome

Timeframe: Pre and post anthracycline treatment

Population: This study was unable to enroll a sufficient number of patients to permit analysis (only 15 patients enrolled)

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.

Outcome measures

Outcome data not reported

Adverse Events

Metoprolol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Gottlieb

UMaryland

Phone: 410-328-8788

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place