Hypertension
Conditions
Keywords
hypertension, sympathetic nervous system
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.
Detailed description
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.
Interventions
DRUGMetoprolol Succinate
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.
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio | january 2018 | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Metoprolol Succinate will receive I-123 MIBG innervation imaging before and after metoprolol succinate | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study terminated | 20 |
Baseline characteristics
| Characteristic | Metoprolol Succinate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
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.
Time frame: january 2018