Trial Outcomes & Findings for Premature Fatigue in Veterans With Heart Failure: Neuronal Influences (NCT NCT02209610)
NCT ID: NCT02209610
Last Updated: 2019-08-02
Results Overview
Following dynamic single leg knee extension exercise for a given duration (4-8 min), the decline in maximal voluntary contraction force will be measured.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
32 participants
Primary outcome timeframe
1 minute after exercise on study day
Results posted on
2019-08-02
Participant Flow
Participant milestones
| Measure |
Patients With Heart Failure: Neuromuscular Abnormalities
Patients with Heart Failure are characterized by excessive exercise-induced neuromuscular fatigue Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
Health Control Subjects and Neuromuscular Function
Health Control Subjects
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Premature Fatigue in Veterans With Heart Failure: Neuronal Influences
Baseline characteristics by cohort
| Measure |
Patients With Heart Failure: Neuromuscular Abnormalities
n=16 Participants
Patients with Heart Failure
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
Health Control Subjects and Neuromuscular Function
n=16 Participants
Health Control Subjects
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 3 • n=5 Participants
|
64 years
STANDARD_DEVIATION 3 • n=7 Participants
|
66 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 minute after exercise on study dayFollowing dynamic single leg knee extension exercise for a given duration (4-8 min), the decline in maximal voluntary contraction force will be measured.
Outcome measures
| Measure |
Patients With Heart Failure: Neuromuscular Abnormalities
n=16 Participants
Patients with Heart Failure
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
Health Control Subjects and Neuromuscular Function
n=16 Participants
Health Control Subjects
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
|---|---|---|
|
Maximal Voluntary Quadriceps Force [% Change From Baseline]
|
-30 percentage change
Standard Deviation 3
|
-5 percentage change
Standard Deviation 2
|
PRIMARY outcome
Timeframe: During (20 second intervals) and 1 minute after exercise on study dayDuring a 2-min maximal voluntary quadriceps contraction, central and peripheral fatigue will develop progressively and significantly more in HF vs. CTRLs.
Outcome measures
| Measure |
Patients With Heart Failure: Neuromuscular Abnormalities
n=16 Participants
Patients with Heart Failure
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
Health Control Subjects and Neuromuscular Function
n=16 Participants
Health Control Subjects
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
|---|---|---|
|
Quadriceps Twitch Force and Voluntary Activation (% Change From Baseline)
Twitch force
|
-60 percentage change
Standard Deviation 5
|
-35 percentage change
Standard Deviation 6
|
|
Quadriceps Twitch Force and Voluntary Activation (% Change From Baseline)
Voluntary activation [VA]
|
-25 percentage change
Standard Deviation 6
|
-20 percentage change
Standard Deviation 5
|
PRIMARY outcome
Timeframe: 1 minute after exercise on study dayCorticospinal responsiveness will be quantified before and after exercise.
Outcome measures
| Measure |
Patients With Heart Failure: Neuromuscular Abnormalities
n=16 Participants
Patients with Heart Failure
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
Health Control Subjects and Neuromuscular Function
n=16 Participants
Health Control Subjects
Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system
Intrathecal Fentanyl: Mu-opioid receptor agonist
|
|---|---|---|
|
Muscle Afferent Affect
|
-30 percent change
Standard Error 3
|
10 percent change
Standard Error 8
|
Adverse Events
Patients With Heart Failure: Neuromuscular Abnormalities
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Control Subjects and Neuromuscular Function
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place