NCT00580619 (CFS&ANS) is a Phase 1 clinical trial of Autonomic Function Testing in Chronic Fatigue Syndrome, sponsored by Vanderbilt University.

Who is sponsoring NCT00580619?

NCT00580619 is sponsored by Vanderbilt University.

What drugs are being tested in NCT00580619?

Interventions in NCT00580619: Autonomic Function Testing, Saline infusions, L-NMMA trimethaphan, methyldopa.

What condition does NCT00580619 study?

NCT00580619 studies Chronic Fatigue Syndrome, Orthostatic Intolerance, Postural Tachycardia Syndrome.

Is NCT00580619 still recruiting?

NCT00580619 is currently completed. Last updated 16 January 2017.

Last reviewed 2017-01-16 · How we verify

NCT00580619: CFS&ANS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Autonomic Nervous System and Chronic Fatigue Syndrome

Completed Phase 1 Last updated 16 January 2017

What this trial tests

Phase 1 trial testing Autonomic Function Testing in Chronic Fatigue Syndrome in 170 participants. Completed in 1 January 2017.

Timeline

1 April 2007

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Vanderbilt University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Enrollment	170
Start date	1 April 2007
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	1 location across United States

Drugs / interventions tested

Autonomic Function Testing
Saline infusions
L-NMMA trimethaphan — full drug profile →
methyldopa (METHYLDOPA) — full drug profile →

Conditions studied

Chronic Fatigue Syndrome — all drugs for Chronic Fatigue Syndrome →
Orthostatic Intolerance — all drugs for Orthostatic Intolerance →
Postural Tachycardia Syndrome — all drugs for Postural Tachycardia Syndrome →

Sponsor

Vanderbilt University

Who can join

Adults 18 to 65, any sex, with Chronic Fatigue Syndrome or Orthostatic Intolerance. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Heart rate
Time frame: Duration of the intervention

Sponsor's own description

The investigators propose to test the hypothesis that the sympathetic nervous system contributes to the cardiovascular and inflammatory abnormalities present in the chronic fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women, and are the cause of significant disability. A substantial proportion of patients referred for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Neurohumoral and haemodynamic profile in postural tachycardia and chronic fatigue syndromes.
Okamoto LE, Raj SR, Peltier A, Gamboa A, et al · · 2012 · cited 57× · PMID 21906029 · DOI 10.1042/cs20110200
Sympathetic activation is associated with increased IL-6, but not CRP in the absence of obesity: lessons from postural tachycardia syndrome and obesity.
Okamoto LE, Raj SR, Gamboa A, Shibao CA, et al · · 2015 · cited 40× · PMID 26453329 · DOI 10.1152/ajpheart.00409.2015

Verify or expand the search:

Other trials of Autonomic Function Testing

Trials testing the same drug.

NCT05977335 — Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT) · not yet recruiting
NCT05344599 — Evaluating the Prevalence of Acute Hepatic Porphyria in Postural Tachycardia Syndrome · active not recruiting

Other recruiting trials for Chronic Fatigue Syndrome

Currently open trials in the same condition.

NCT07009691 — Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS · NA · recruiting
NCT06585254 — tVNS in Long COVID-19 · NA · recruiting
NCT05741112 — The Long COVID-19 Wearable Device Study · NA · recruiting
NCT05967052 — Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitati · Phase 2 · recruiting
NCT05525598 — Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders · NA · recruiting

Other Vanderbilt University trials

Trials by the same sponsor.

NCT06598579 — Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda · NA · not yet recruiting
NCT06482944 — Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes · NA · recruiting
NCT07220746 — Understanding Cognitive-Academic Bidirectionality in Math Learning Disabilities · NA · recruiting
NCT06464497 — Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity · NA · recruiting
NCT05472961 — Eye Movements in Visual Search · NA · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00580619 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University
Last refreshed: 16 January 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00580619.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing