Trial Outcomes & Findings for Targeting Inflammation to Treat Cardiovascular Aging (NCT NCT01775865)

Results Overview

Aortic stiffness

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Change in CFPWV from baseline at 4 weeks

Results posted on

2018-05-31

Participant Flow

A total of 59 participants were consented/enrolled. A total of 13 were excluded or lost to follow up after consent (n=8 did not meet inclusion criteria after screening; n=1 lost to follow up; n=1 time committment; n=1 moved out of state; n=2 other).

Participant milestones

Participant milestones
Measure	Salsalate Salsalate capsule 1.5 g twice per day by mouth for 4 weeks Salsalate	Placebo Placebo capsule twice per day by mouth for 4 weeks Placebo (for salsalate)	Young Control No intervention; Baseline measurements only, participants not randomized
Overall Study STARTED	14	14	17
Overall Study COMPLETED	11	13	17
Overall Study NOT COMPLETED	3	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Targeting Inflammation to Treat Cardiovascular Aging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Salsalate n=14 Participants Salsalate capusule 1.5 g twice per day by mouth for 4 weeks	Placebo n=14 Participants Placebo capsule twice per day by mouth for 4 weeks	Young Control n=17 Participants No intervention, not randomized; Baseline measurements only	Total n=45 Participants Total of all reporting groups
Age, Continuous	60.6 Years STANDARD_DEVIATION 7.4 • n=5 Participants	55.8 Years STANDARD_DEVIATION 5.3 • n=7 Participants	26.2 Years STANDARD_DEVIATION 5.2 • n=5 Participants	48.1 Years STANDARD_DEVIATION 16.8 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	21 Participants n=4 Participants

PRIMARY outcome

Timeframe: Change in CFPWV from baseline at 4 weeks

Population: After baseline measurements, there were 3 dropouts in salsalate group for a total of 11 completed in salsalate, and 1 dropout in the placebo group for a total of 13 completed in placebo.

Aortic stiffness

Outcome measures

Outcome measures
Measure	Salsalate n=14 Participants Received 4 weeks of daily oral salsalate	Placebo n=14 Participants Received 4 weeks of placebo	Young Control Group n=17 Participants No Intervention; Baseline measurements only, participants not randomized
Carotid-femoral Pulse Wave Velocity (CFPWV) 4 weeks	839.6 cm/sec Standard Error 66.4	740.01 cm/sec Standard Error 45.6	NA cm/sec Standard Error NA Data not collected from any participant in the Young Control Arm/Group at 4 weeks
Carotid-femoral Pulse Wave Velocity (CFPWV) Baseline	831.3 cm/sec Standard Error 45.3	785.1 cm/sec Standard Error 41.1	538.0 cm/sec Standard Error 17.9

SECONDARY outcome

Timeframe: Change from baseline brachial artery FMD at 4 weeks

Population: After baseline measurements, there were 3 dropouts in salsalate group and 1 FMD that was not able to be anayzed (poor image quality) for a total of 10 in salsalate for FMD. There was 1 dropout in the placebo group and 2 FMDs not analyzed (poor image quality) for a total of 11 analyzed in placebo for FMD.

Endothelial function

Outcome measures

Outcome measures
Measure	Salsalate n=14 Participants Received 4 weeks of daily oral salsalate	Placebo n=14 Participants Received 4 weeks of placebo	Young Control Group n=17 Participants No Intervention; Baseline measurements only, participants not randomized
Brachial Artery Flow-mediated Dilation (FMD) Baseline	3.49 Percent dilation Standard Error 1.05	3.57 Percent dilation Standard Error 1.14	5.88 Percent dilation Standard Error 0.97
Brachial Artery Flow-mediated Dilation (FMD) 4 Weeks	4.60 Percent dilation Standard Error 1.24	2.50 Percent dilation Standard Error 1.32	NA Percent dilation Standard Error NA Only baseline date were collected, no 4 week data were collected.

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline E' at 4 weeks

Population: Data were not obtained because cardiac echos could not be performed in participants because of lack of equipment

Left ventricular diastolic dysfunction

Outcome measures

Outcome data not reported

Adverse Events

Salsalate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Young Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Salsalate n=14 participants at risk Salsalate 1.5 g twice per day by mouth for 4 weeks	Placebo n=14 participants at risk Placebo capusule twice per day by mouth for 4 weeks	Young Control Group n=17 participants at risk No intervention; Baseline measurements only; Participants not randomized
Hepatobiliary disorders Elevated AST/ALT	7.1% 1/14 • Number of events 1	0.00% 0/14	0.00% 0/17
Eye disorders Allergic reaction	0.00% 0/14	7.1% 1/14 • Number of events 1	0.00% 0/17

Additional Information

Gary Pierce

University of Iowa

Phone: 319-335-9487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place