Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Adverse events reported with beta-blockers as primary therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metoprolol succinate | Experimental | Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol Succinate | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Myron C Gerson, M.D. | University of Cincinnati | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study was stopped early due to concerns resulting from a publication reporting an increased in mortality in cardiac deaths in patients treated with beta-blockers as the primary drug for hypertension. Although no adverse reactions were observed in the present study, it was decided by the PI that beta-blockers could not ethically be continued.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Treated with metoprolol succinate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metoprolol Succinate | will receive I-123 MIBG innervation imaging before and after metoprolol succinate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | january 2018 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metoprolol Succinate | Patients receive I-123 MIBG imaging before and after metoprolol succinate. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myron Gerson MD | University of Cincinnati | 5135583974 | myron.gerson@uc.edu |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 24 |
| 0 |
| 24 |
Not provided
Not provided
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |