Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure

The Center for Clinical Research, Winston-Salem, NC

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: clonidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01297335

1461 Clonidine

1461 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.

Full description

Hypertension occurs commonly, is associated with major morbidity and mortality, and responds poorly to current therapies in a small minority of compliant patients. The goal of this investigator-initiated study is to determine whether intrathecal administration of clonidine reduces blood pressure in hypertensive patients, focusing on a group who often achieve inadequate blood pressure control with multiple drug therapy.

After consent, pts will be screened and if qualified brought into center and intrathecal injection of clonidine given. Patients will be closely monitored for 4 hours, while data is collected.

Enrollment: 10 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of Hypertension
• Stable systolic blood pressure >140 mmHg and < 190 mmHg
• On 3 or more antihypertensive medications
• On a diuretic
• Patients must be able to understand the risks

Exclusion criteria

• Allergy to clonidine

• Presently on clonidine orally or transdermally

• Known or suspected correctable causes of secondary hypertension

• Breast Feeding or Pregnant women

• Unstable Ischemic Heart Disease

• Unstable Angina

• Intracoronary Stent Placement

• Coronary bypass within last 6 months

• Myocardial Infarction within last 6 months

• Congestive Failure

• Cardiac Arrhythmias

• Known Cerebral Vascular Disease

• Renal Disease

• Evidence of Injection Site Infection

• Known Bleeding Disorders

• Hepatic Insufficiency

• Renal Insufficiency

• Participation in an investigational drug study within 30 day of enrollment

• Prohibited Medications:

  • Clonidine
  • Yohimbine
  • Tricyclic Antidepressants
  • Mirtazapine
  • Digitalis
  • Reserpine
  • Guanethidine
  • Non-Steroidal Anti-inflammatory Medication
  • Alcohol or Barbiturates within 48 hours of study procedure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intrathecal Clonidine

Experimental group

Description:

Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.

Treatment:

Drug: clonidine