Trial Outcomes & Findings for Red Blood Cell ATP Release and Vascular Function in Humans (NCT NCT03404843)
NCT ID: NCT03404843
Last Updated: 2020-02-27
Results Overview
Forearm blood flow measured using Doppler ultrasound before and after 5 minutes of exposure to hypoxia (breathing a mix of low-oxygen gas and room air to achieve oxygen saturations of \~80%).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Within 4 hours after administration of intervention
Results posted on
2020-02-27
Participant Flow
Participant milestones
| Measure |
Fasudil, Then Saline
Participants were randomized to receive a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release.
|
Saline, Then Fasudil
Participants were randomized to receive a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Fasudil, Then Saline
Participants were randomized to receive a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release.
|
Saline, Then Fasudil
Participants were randomized to receive a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release.
|
|---|---|---|
|
Overall Study
Study difficulties unrelated to Tx
|
4
|
1
|
Baseline Characteristics
Red Blood Cell ATP Release and Vascular Function in Humans
Baseline characteristics by cohort
| Measure |
Fasudil, Then Saline
n=13 Participants
Participants were randomized to receive a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release.
|
Saline, Then Fasudil
n=13 Participants
Participants were randomized to receive a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-30 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
60-80 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
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
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Body Mass Index
|
24.9 kg/m^2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 1.6 • n=7 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Within 4 hours after administration of interventionPopulation: All participants who completed both interventions (crossover design) with outcome data collected
Forearm blood flow measured using Doppler ultrasound before and after 5 minutes of exposure to hypoxia (breathing a mix of low-oxygen gas and room air to achieve oxygen saturations of \~80%).
Outcome measures
| Measure |
Young Saline
n=11 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Young Fasudil
n=11 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
Older Saline
n=13 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Older Fasudil
n=13 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
|---|---|---|---|---|
|
Forearm Blood Flow Responses to Hypoxia After Administration of Intervention
|
6.3 mL/min
Standard Error 1.2
|
6.2 mL/min
Standard Error 1.2
|
2.1 mL/min
Standard Error 0.6
|
8.4 mL/min
Standard Error 1.9
|
PRIMARY outcome
Timeframe: Within 4 hours after administration of interventionPopulation: All participants who completed both interventions (crossover design) with outcome data collected
Forearm blood flow measured using Doppler ultrasound before and during continuous rhythmic handgrip exercise at a low, moderate, and high intensity workload (4 minutes at each workload for 12 minutes in total).
Outcome measures
| Measure |
Young Saline
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Young Fasudil
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
Older Saline
n=13 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Older Fasudil
n=13 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
|---|---|---|---|---|
|
Forearm Blood Flow Responses to Exercise After Administration of Intervention
|
315.4 mL/min
Standard Error 31.0
|
283.0 mL/min
Standard Error 25.4
|
255.3 mL/min
Standard Error 19.9
|
304.2 mL/min
Standard Error 25.2
|
PRIMARY outcome
Timeframe: Within 4 hours after administration of interventionPopulation: All participants who completed both interventions (crossover design) with outcome data collected
Venous plasma concentrations of ATP measured using a luminometer before and after 5 minutes of exposure to hypoxia (breathing a mix of low-oxygen gas and room air to achieve oxygen saturations of \~80%).
Outcome measures
| Measure |
Young Saline
n=9 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Young Fasudil
n=9 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
Older Saline
n=11 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Older Fasudil
n=11 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
|---|---|---|---|---|
|
Change in ATP Release to Hypoxia After Administration of Intervention
|
21.6 nmol/L
Standard Error 10.5
|
5.3 nmol/L
Standard Error 8.0
|
5.3 nmol/L
Standard Error 5.4
|
17.4 nmol/L
Standard Error 13.2
|
PRIMARY outcome
Timeframe: Within 4 hours after administration of interventionPopulation: All participants who completed both interventions (crossover design) with outcome data collected
Venous plasma concentrations of ATP measured using a luminometer before and during continuous rhythmic handgrip exercise at a low, moderate, and high intensity workload (4 minutes at each workload for 12 minutes in total).
Outcome measures
| Measure |
Young Saline
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Young Fasudil
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
Older Saline
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Older Fasudil
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
|---|---|---|---|---|
|
Change in ATP Release to Exercise After Administration of Intervention
|
45.6 nmol/L
Standard Error 16.8
|
42.2 nmol/L
Standard Error 15.1
|
28.4 nmol/L
Standard Error 7.9
|
46.2 nmol/L
Standard Error 15.2
|
SECONDARY outcome
Timeframe: Immediately following administration of interventionPopulation: All participants who completed both interventions (crossover design) with outcome data collected
Arterial stiffness measured non-invasively using a SphygmoCor system after administration of saline (placebo) and fasudil. This is a randomized crossover design study, so participants will receive 1 treatment (saline or fasudil) on their first visit and the other treatment on their second visit.
Outcome measures
| Measure |
Young Saline
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Young Fasudil
n=12 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
Older Saline
n=13 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
|
Older Fasudil
n=13 Participants
Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
|
|---|---|---|---|---|
|
Arterial Stiffness After Administration of Intervention
|
5.4 m/s
Standard Error 0.2
|
5.2 m/s
Standard Error 0.2
|
7.8 m/s
Standard Error 0.4
|
7.6 m/s
Standard Error 0.4
|
Adverse Events
Young Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Young Fasudil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Older Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Older Fasudil
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