Trial Outcomes & Findings for Targeting Sympathetic Overactivity in Heart Failure Patients With Statins (NCT NCT01097785)
NCT ID: NCT01097785
Last Updated: 2016-11-21
Results Overview
Muscle sympathetic nerve activity will be assessed after one month of placebo and statin therapy; measured in bursts/100 heartbeats.
COMPLETED
NA
12 participants
Baseline and 30 days
2016-11-21
Participant Flow
A total of 12 participants were recruited; 6 were allocated to each arm.
Participant milestones
| Measure |
Simvastatin, Then Placebo
Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
|
Placebo, Then Simvastatin
Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
|
|---|---|---|
|
Cycle 1 (30 Days)
STARTED
|
6
|
6
|
|
Cycle 1 (30 Days)
COMPLETED
|
6
|
6
|
|
Cycle 1 (30 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
6
|
6
|
|
Washout (2 Weeks)
COMPLETED
|
6
|
6
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Cycle 3 (30 Days)
STARTED
|
6
|
6
|
|
Cycle 3 (30 Days)
COMPLETED
|
6
|
6
|
|
Cycle 3 (30 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Sympathetic Overactivity in Heart Failure Patients With Statins
Baseline characteristics by cohort
| Measure |
Simvastatin, Then Placebo
n=6 Participants
Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
|
Placebo, Then Simvastatin
n=6 Participants
Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 3 • n=93 Participants
|
51 years
STANDARD_DEVIATION 3 • n=4 Participants
|
51 years
STANDARD_DEVIATION 3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Muscle Sympathetic Nerve Activity
|
45 bursts/100 heartbeats
STANDARD_DEVIATION 14 • n=93 Participants
|
59 bursts/100 heartbeats
STANDARD_DEVIATION 13 • n=4 Participants
|
52 bursts/100 heartbeats
STANDARD_DEVIATION 14 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30 daysMuscle sympathetic nerve activity will be assessed after one month of placebo and statin therapy; measured in bursts/100 heartbeats.
Outcome measures
| Measure |
Simvastatin
n=12 Participants
40 mg Simvastatin 1 pill every day for 30 days
|
Placebo
n=12 Participants
Placebo cap 1 pill every day for 30 days
|
|---|---|---|
|
Change in Muscle Sympathetic Nerve Activity in Bursts Per 100 Heartbeats
|
59 bursts/100 heartbeats
Standard Error 5
|
45 bursts/100 heartbeats
Standard Error 6
|
SECONDARY outcome
Timeframe: Baseline and 30 daysReactive Oxygen Species will be assessed after one month of placebo and statin therapy; measured using electron parametric resonance spectroscopy (EPR).
Outcome measures
| Measure |
Simvastatin
n=12 Participants
40 mg Simvastatin 1 pill every day for 30 days
|
Placebo
n=12 Participants
Placebo cap 1 pill every day for 30 days
|
|---|---|---|
|
Change in Measures of Reactive Oxygen Species in the Blood
|
8671500.00 EPR Arbitrary Units
Standard Error 1584626.44
|
14056500.00 EPR Arbitrary Units
Standard Error 1010765.39
|
Adverse Events
Simvastatin
Placebo
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