Clinical trial NCT01297335: Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
Official title: Hemodynamic Effect of Intrathecal Clonidine in Hypertensive Subjects: A Pilot Study to Assess Its Effectiveness in Hypertensive Subjects With Poor Blood Pressure Control (Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: intrathecal
clonidine
poorly
controlled
hypertension
Lead sponsor: The Center for Clinical Research, Winston-Salem, NC
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-02-16
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Blood Pressure After Intrathecal Injection of Clonidine.
timeFrame: Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection
Secondary outcomes:
measure: Likert Scale Pain Rating
timeFrame: Pre-dose and 1 hour post injection.
measure: Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection
timeFrame: Before clonidine injection (Baseline), and at 1 hour after clonidine injection.
Other outcomes:
Locations:
Study officials:
affiliation: Owner
name: Richard L. Rauck, MD
role: PRINCIPAL_INVESTIGATOR
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