Trial Outcomes & Findings for Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients? (NCT NCT01605370)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

baseline, 6 months

Results posted on

2014-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Nebivolol Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily. Nebivolol: Nebivolol 2.5 mg once daily	Metoprolol Succinate Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily. Metoprolol succinate: Metoprolol succinate 50 mg once daily
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nebivolol Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily. Nebivolol: Nebivolol 2.5 mg once daily	Metoprolol Succinate Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily. Metoprolol succinate: Metoprolol succinate 50 mg once daily
Overall Study Adverse Event	1	0

Baseline Characteristics

Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nebivolol n=1 Participants Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily. Nebivolol: Nebivolol 2.5 mg once daily	Metoprolol Succinate Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily. Metoprolol succinate: Metoprolol succinate 50 mg once daily	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 participants n=5 Participants	—	1 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Female	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Male	1 participants n=5 Participants	—	1 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 months

Population: Data were not collected for the single participant, so no analysis was performed.

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

Outcome measures

Outcome data not reported

Adverse Events

Nebivolol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Metoprolol Succinate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nebivolol n=1 participants at risk Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily. Nebivolol: Nebivolol 2.5 mg once daily	Metoprolol Succinate Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily. Metoprolol succinate: Metoprolol succinate 50 mg once daily
Respiratory, thoracic and mediastinal disorders Wheezing	100.0% 1/1 • Number of events 1	— 0/0

Additional Information

Marek Belohlavek, M.D., Ph.D.

Mayo Clinic

Phone: 408-301-6694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place