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

NCT ID: NCT01297335

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-07-31

Brief Summary

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.

Detailed 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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intrathecal Clonidine

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.

Group Type: EXPERIMENTAL

clonidine

Intervention Type: DRUG

Intrathecal Clonidine

Interventions

clonidine

Intrathecal Clonidine

Intervention Type: DRUG

Other Intervention Names

catapres

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

The Center for Clinical Research, Winston-Salem, NC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L. Rauck, MD

Role: PRINCIPAL_INVESTIGATOR

Owner

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Other Identifiers

1461

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1461 Clonidine

Identifier Type: -

Identifier Source: org_study_id