Overview

This trial is active, not recruiting.

Condition stress disorders, post-traumatic
Treatments microneurography, combat virtual reality video clip, handgrip exercise, cold pressor test (cpt), sodium nitroprusside (snp), phenylephrine, losartan, atenolol
Phase phase 2
Sponsor Emory University
Collaborator American Heart Association
Start date October 2015
End date August 2018
Trial size 134 participants
Trial identifier NCT02560805, IRB00082400

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Subjects with post-traumatic stress disorder (PTSD) will be evaluated using microneurography, static handgrip exercise, cold pressor test, combat virtual reality video clip, and baroreflex sensitivity using sodium nitroprusside and phenylephrine. For the second phase, they will be randomized to either losartan or atenolol.
microneurography
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).
combat virtual reality video clip
Subjects will watch a video clip of combat on a computer screen or wearing video goggles.
handgrip exercise
Subjects will squeeze a hand dynamometer intermittently.
cold pressor test (cpt)
Subjects' hand will be submerged in cold water (~0-1°C) up to the wrist for 1 minute.
sodium nitroprusside (snp) Nitropress
Subjects will receive sodium nitroprusside 100 µg, which is bolused through an antecubital intravenous catheter.
phenylephrine
Subjects will receive phenylephrine 150 µg, which is bolused through an antecubital intravenous catheter 60 seconds after the sodium nitroprusside bolus
losartan Cozaar
Subjects will receive Losartan 25 mg once a day orally up to 12 weeks
atenolol Tenormin
Subjects will receive Atenolol 25 mg once a day orally up to 12 weeks
(Experimental)
Healthy controls will be evaluated using microneurography, static handgrip exercise, cold pressor test, combat virtual reality video clip, and baroreflex sensitivity using sodium nitroprusside and phenylephrine.
microneurography
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).
combat virtual reality video clip
Subjects will watch a video clip of combat on a computer screen or wearing video goggles.
handgrip exercise
Subjects will squeeze a hand dynamometer intermittently.
cold pressor test (cpt)
Subjects' hand will be submerged in cold water (~0-1°C) up to the wrist for 1 minute.
sodium nitroprusside (snp) Nitropress
Subjects will receive sodium nitroprusside 100 µg, which is bolused through an antecubital intravenous catheter.
phenylephrine
Subjects will receive phenylephrine 150 µg, which is bolused through an antecubital intravenous catheter 60 seconds after the sodium nitroprusside bolus

Primary Outcomes

Measure
Muscle sympathetic nerve activity at rest and during mental stress
time frame: 12 weeks

Secondary Outcomes

Measure
Change in Baroreflex sensitivity (BRS) at rest and during mental stress
time frame: 12 weeks
Change in inflammatory biomarkers
time frame: 12 weeks
Change in Blood Pressure
time frame: 12 weeks
Change in PTSD symptoms
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Post-Traumatic Stress Disorder and Cardiovascular Disease Risk: Role of Sympathetic Overactivity and Angiotensin II
Principal investigator Jeanie Park, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Emory University.