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Study 2: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients

Primary Purpose

Hypertension

Status

Not yet recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Minocycline Group

Placebo Group

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Resistent Hypertension, Systolic Blood Pressure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

Greater than 18 and less than 86 years of age;
On stable medication regimen
o Full-tolerated doses of 3 or more anti-hypertensive medications of different classes, one of which must be a diuretic (with no changes for a minimum of two months prior to screening) that is expected to be maintained without changes for at least 3 months.
Office systolic blood pressure (SBP) of greater than 160 mmHg based on an average of 3 blood pressure readings measured at both initial screening visit
The individual agrees to have all study procedures performed
Willing to provide written consent
Females with childbearing potential must not be pregnant.

Exclusion

eGFR of < 45 mL/min/1.73m2, using the MDRD calculation.
More than one in-patient hospitalization for an anti-hypertensive crisis within the year.
More than one episode(s) of orthostatic hypotension (reduction of SBP of ≥ 20 mmHg of diastolic blood pressure (DBP) of ≥ 10 mmHg within 3 minutes of standing).
History of myocardial infarction (MI), unstable angina pectoris, syncope or a cardiovascular accident within 6 months of screening period
Clinically significant atrioventricular (AV) conduction disturbances and/or arrhythmias (e.g. 2nd or 3rd degree AV block);
Current of past history of heart failure (≤40% left ventricular ejection fraction (EF).
Major of psychotropic agents and antidepressants.
Use of nonsteroidal anti-inflammatory drug (NSAIDs)
Known hypersensitivity or contraindication to Minocycline or other tetracycline.
Smoking
Concurrent severe disease (such as neoplasm or HIV positive or AIDS).

Sites / Locations

UF Health Cardiovascular Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Minocycline Group

Placebo Group

Arm Description

These subjects will start with minocycline for 16 weeks, followed by a washout period for 3 weeks, then will receive a placebo for 16 weeks, followed by a washout period for 3 weeks, then will finish with minocycline for 16 weeks.

These subjects will start with placebo (this will look like minocycline) for 16 weeks, followed by a washout period for 3 weeks, then will receive a minocycline for 16 weeks, followed by a washout period for 3 weeks, then will finish with placebo for 16 weeks.

Outcomes

Primary Outcome Measures

Reduction of ambulatory blood pressure

Change in systolic blood pressure.

Secondary Outcome Measures

Full Information

NCT ID

NCT02133885

First Posted

May 6, 2014

Last Updated

May 8, 2023

Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT02133885

Brief Title

Study 2: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients

Official Title

Angiotensin and Neuroimmune Activation in Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease, diabetes, obesity and metabolic syndrome. Despite advances in life style modification and multi-drug therapies, 20-30% of all hypertensive patients remain resistant. These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and norepinephrine spillover, and low parasympathetic activity. It is generally accepted that this uncontrolled, resistant HTN is primarily "neurogenic" in origin, involving over activity of the sympathetic nervous system that initiates and sustains HTN. Thus, a mechanism-based breakthrough is imperative to develop novel strategies to prevent and perhaps eventually cure neurogenic hypertension (NH). This study is a double-blind, placebo-controlled, cross-over design to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals.

Detailed Description

This is a double-blind, placebo-controlled, cross over design to evaluate the effects of minocycline in patients with resistent hypertension. After providing informed consent, patients will have baseline and followup visits during which a brief physical examination will be performed, medical history, assessment of medication compliance and tolerance, and vital signs will be completed. Subjects will undergo blood (lipid panel, high sensitivity-C reactive protein, high sensitivity troponin, glucose, metabolic profile, lipid panel, Cystatin C and albumin) and urine studies at the baseline visit and at 16, 19, 35 and 54 weeks. Patients will have ambulatory BP monitoring at baseline and at the end of each treatment period. Patients will be randomized to drug scheme A or B. One scheme will follow the following order: 16 weeks of minocycline, followed by a 3 week wash out period, then 16 weeks of placebo, then 3 weeks of wash out and a final 16 week period of minocycline. The other scheme will consist of 16 weeks of placebo, followed by 3 week wash out period, followed by 16 weeks of minocycline, then 3 week wash out and a final 16 weeks of placebo. Study visits will occur at study entry (baseline/randomization), 16 weeks, 19 weeks, 35 weeks, 38 weeks, and 54 weeks for each group. Patient participation will end after 56 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Resistent Hypertension, Systolic Blood Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Minocycline Group

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Minocycline Group

Intervention Description

Intervention Type

Other

Intervention Name(s)

Placebo Group

Intervention Description

These subjects will start with placebo (tablet looking just like minocycline) for 16 weeks, followed by a washout period for 3 weeks, then will receive minocycline for 16 weeks, followed by a washout period for 3 weeks, then will finish with placebo for 16 weeks.

Primary Outcome Measure Information:

Title

Reduction of ambulatory blood pressure

Description

Change in systolic blood pressure.

Time Frame

Change in baseline to week 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: Greater than 18 and less than 86 years of age; On stable medication regimen o Full-tolerated doses of 3 or more anti-hypertensive medications of different classes, one of which must be a diuretic (with no changes for a minimum of two months prior to screening) that is expected to be maintained without changes for at least 3 months. Office systolic blood pressure (SBP) of greater than 160 mmHg based on an average of 3 blood pressure readings measured at both initial screening visit The individual agrees to have all study procedures performed Willing to provide written consent Females with childbearing potential must not be pregnant. Exclusion eGFR of < 45 mL/min/1.73m2, using the MDRD calculation. More than one in-patient hospitalization for an anti-hypertensive crisis within the year. More than one episode(s) of orthostatic hypotension (reduction of SBP of ≥ 20 mmHg of diastolic blood pressure (DBP) of ≥ 10 mmHg within 3 minutes of standing). History of myocardial infarction (MI), unstable angina pectoris, syncope or a cardiovascular accident within 6 months of screening period Clinically significant atrioventricular (AV) conduction disturbances and/or arrhythmias (e.g. 2nd or 3rd degree AV block); Current of past history of heart failure (≤40% left ventricular ejection fraction (EF). Major of psychotropic agents and antidepressants. Use of nonsteroidal anti-inflammatory drug (NSAIDs) Known hypersensitivity or contraindication to Minocycline or other tetracycline. Smoking Concurrent severe disease (such as neoplasm or HIV positive or AIDS).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dana Leach, DNP

Phone

352-273-8933

leachdd@medicine.ufl.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Long, RN

Phone

352-273-8933

sarah.long@medicine.ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl Pepine, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

UF Health Cardiovascular Clinic

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dana Leach, DNP

Phone

352-273-8933

leachdd@medicine.ufl.edu

First Name & Middle Initial & Last Name & Degree

Mohan Raizada, PhD

12. IPD Sharing Statement

Learn more about this trial

Study 2: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients

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