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NCT02209610 · ClinicalTrials.gov registry record · Early Phase 1

Premature Fatigue in Veterans With Heart Failure: Neuronal Influences

A Early Phase 1 study, sponsored by VA Office of Research and Development.

Completed
Registry status
Early Phase 1
Development phase
32
Enrollment target

NCT02209610: Completed Early Phase 1 study, sponsored by VA Office of Research and Development.

NCT02209610 is a Early Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02209610, a Early Phase 1 study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Early Phase 1
Development phase
32 participants
Enrollment target

Study Summary

A hallmark of patients with heart failure (HF) is premature fatigue which impairs their quality of life and depicts a major source of morbidity. Premature fatigue may be attributed to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e. central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force and power generating capacity and to a compromised ability to perform whole body activities (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers from the working muscle play a critical role in the development of both components of fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during exercise and thereby exaggerate the development of central fatigue. In contrast, muscle afferents optimize muscle O2 delivery through the precise regulation of circulation and ventilation during exercise and thereby attenuate the development of peripheral fatigue.

Primary Outcome

Following dynamic single leg knee extension exercise for a given duration (4-8 min), the decline in maximal voluntary contraction force will be measured.

Interventions

  • DEVICE Electrical and Magnetic Nerve Stimulators
  • DRUG Intrathecal Fentanyl

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2015-07-01
Est. Completion 2017-01-15
Phase Early Phase 1
VA Office of Research and Development

1,668 total trials

What the finished NCT02209610 record still lists

NCT02209610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Electrical and Magnetic Nerve Stimulators is the first listed.

NCT02209610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02209610 about?

NCT02209610 is a clinical study titled "Premature Fatigue in Veterans With Heart Failure: Neuronal Influences". A hallmark of patients with heart failure (HF) is premature fatigue which impairs their quality of life and depicts a major source of morbidity. Premature fatigue may be attributed to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or b) failure of the central n...

What is the current status of trial NCT02209610?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2015-07-01. Estimated completion is 2017-01-15.

What interventions are being tested in trial NCT02209610?

The interventions under investigation include: Electrical and Magnetic Nerve Stimulators (DEVICE), Intrathecal Fentanyl (DRUG).

Who is sponsoring clinical trial NCT02209610?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02209610's enrollment target sits among peer trials

32 775th of 2000 higher than 1,208 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02209610, the US trial registry maintained by the National Library of Medicine. NCT02209610 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.