NCT02560805|SuspendedPhase 2FDA Drug

Study Stopped

Enrollment and study activities are temporarily suspended due to COVID-19.

Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV

ANG-P

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

Emory University ClinicalTrials.gov

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1 other identifier

IRB00082400

Study Type

interventional

Target

134

Locations

1 country

Sites

Timeline

RegisteredSep 2015

StartedOct 2015

CompletionFeb 2026

Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Trial recruitment is currently suspended

Enrollment

134

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2015

Longer than P75 for phase_2

Geographic Reach

1 country

1 active site

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10.3 years study duration

First Submitted

Initial submission to the registry

September 24, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed

6 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed

10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed

Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

10.3 years

First QC Date

September 24, 2015

Last Update Submit

March 3, 2025

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

Change in Muscle Sympathetic Nerve Activity (MSNA)
Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency measured a bursts per minute. MSNA will be examined at rest and during mental stress.
Baseline, after study intervention (up to 14 weeks)

Secondary Outcomes (6)

Change in Baroreflex Sensitivity (BRS)
Baseline, after study intervention (up to 14 weeks)
C-reactive protein (CRP)
Baseline, after study intervention (up to 14 weeks)
Interleukin 2 (IL-2)
Baseline, after study intervention (up to 14 weeks)
Interleukin 6 (IL-6)
Baseline, after study intervention (up to 14 weeks)
Angiotensin II (ATII)
Baseline, after study intervention (up to 14 weeks)
+1 more secondary outcomes

Study Arms (6)

Veterans with Post-traumatic Stress Disorder (PTSD)

EXPERIMENTAL

For examining Objective 1 of this study, participants 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.

Procedure: MicroneurographyBehavioral: Combat virtual reality video clipProcedure: Handgrip ExerciseProcedure: Cold Pressor Test (CPT)Drug: Sodium Nitroprusside (SNP)Drug: Phenylephrine

Control

EXPERIMENTAL

For examining Objective 1 of this study, 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.

Procedure: MicroneurographyBehavioral: Combat virtual reality video clipProcedure: Handgrip ExerciseProcedure: Cold Pressor Test (CPT)Drug: Sodium Nitroprusside (SNP)Drug: Phenylephrine

Losartan

EXPERIMENTAL

Participants with PTSD randomized to receive losartan for 8 to 14 weeks.

Drug: Losartan

Atenolol

ACTIVE COMPARATOR

Participants with PTSD randomized to receive atenolol for 8 to 14 weeks.

Drug: Atenolol

Transcutaneous Vagal Nerve Stimulation (tVNS)

EXPERIMENTAL

Participants with PTSD randomized to receive treatment with tVNS for 8 to 14 weeks.

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

Sham Transcutaneous Vagal Nerve Stimulation (tVNS)

SHAM COMPARATOR

Participants with PTSD randomized to receive treatment with sham-tVNS for 8 to 14 weeks.

Device: Sham Transcutaneous Vagal Nerve Stimulation (tVNS)

Interventions

MicroneurographyPROCEDURE

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).