RecruitingPhase 2NCT02560805

Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV

Post-Traumatic Stress Disorder and Cardiovascular Disease Risk: Role of Sympathetic Overactivity and Angiotensin II

Sponsor

Emory University

Enrollment

134 participants

Start Date

Oct 1, 2015

Study Type

INTERVENTIONAL

Conditions

Stress Disorders, Post-Traumatic

Summary

The purpose of this study is to find out why patients with post-traumatic stress disorder (PTSD) have an increased risk for heart disease and high blood pressure later in life. A second purpose is to find out what causes PTSD patients to have high adrenaline levels during stress. This study will also test if a medicine called losartan improves high adrenaline levels in patients with PTSD and if a certain gene that has to do with high blood pressure might be associated with high adrenaline levels.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

veterans ages 18-65 years old with PTSD and without PTSD (controls) matched for age, gender, and race.

Exclusion Criteria17

pregnancy
hypertension
diabetes
heart or vascular disease
illicit drug use
excessive alcohol use (>2 drinks per day)
hyperlipidemia
autonomic dysfunction
current treatment with clonidine, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, or angiotensin II receptor blockers (ARBs)
treatment with monoamine oxidase (MAO) inhibitors within the last 14 days
any serious systemic disease
chronic kidney disease defined as estimated glomerular filtration rate (GFR) < 60 cc/min
hyperkalemia (serum potassium > 5 meq/dL)
systolic blood pressure < 100 mm Hg
diastolic blood pressure < 60 mm Hg
heart rate < 50 beats/min
known hypersensitivity to ARBs or beta blockers

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Interventions

PROCEDUREMicroneurography

Skin will be stimulated with a pencil-shaped electrode to find a certain nerve. Once the nerve is found, two tiny sterile wire needles (about the size of acupuncture needles) will be put in the skin. One needle is put just under the skin at a short distance away from the nerve, and the other one into the nerve. The needles are attached to a computer recorder to record the nerve activity. It may take up to one hour to get the needles in the right place. After the tiny needle is in the right place, investigators record nerve activity at rest for about 10 minutes. Then, it will be recorded throughout the rest of the visit (up to 4 hours).

BEHAVIORALCombat virtual reality video clip

Subjects will watch a video clip of combat on a computer screen or wearing video goggles.

PROCEDUREHandgrip Exercise

Subjects will squeeze a hand dynamometer intermittently.

PROCEDURECold Pressor Test (CPT)

Subjects' hand will be submerged in cold water (\~0-1°C) up to the wrist for 1 minute.

DRUGSodium Nitroprusside (SNP)

Subjects will receive sodium nitroprusside 100 µg, which is bolused through an antecubital intravenous catheter.

DRUGPhenylephrine

Subjects will receive phenylephrine 150 µg, which is bolused through an antecubital intravenous catheter 60 seconds after the sodium nitroprusside bolus

DRUGLosartan

Losartan will be administered as 25 mg taken orally, once a day for to 8 to 14 weeks.

DRUGAtenolol

Atenolol will be administered as 25 mg taken orally, once a day for to 8 to 14 weeks.

DEVICETranscutaneous Vagal Nerve Stimulation (tVNS)

Transcutaneous vagal nerve stimulation (tVNS) is administered using the gammaCore (ElectroCore) TENS device. The gammaCore device is a multi-use, hand-held, rechargeable portable device consisting of a rechargeable battery, signal generating and amplifying electronics, and two buttons to power on the device and for operator control of the stimulation intensity (range 0-40). A small amount of conductive gel is applied to the pair of stainless steel round discs on the device are placed vertically on the skin with the gel. The stimulation is increased until there is a strong vibration and slight muscle contraction in the lower face or neck (usual intensity 15-25). Then the dose is delivered for 2 minutes on the left side of the neck, and on the right side of the neck, for a total of 4 minutes of treatment. Participants will be instructed on the usage of the device and will self-administer up to 4 treatments twice per day.

DEVICESham Transcutaneous Vagal Nerve Stimulation (tVNS)

A sham device that is identical to the gammaCore device will be provided to participants. Participants will be instructed on the usage of the device and will self-administer up to 4 treatments twice per day.