Trial Outcomes & Findings for Cilostazol for HFpEF (NCT NCT05126836)
NCT ID: NCT05126836
Last Updated: 2023-12-15
Results Overview
The Kansas City Cardiomyopathy Questionnaire contains 12 items that measure the effect of heart failure on health and quality of life. Total scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-12-15
Participant Flow
Participant milestones
| Measure |
Cilostazol First (1 Week), Then Placebo (1 Week)
First week, Cilostazol 100mg twice a day
Second week, Placebo twice a day
Third week, Cilostazol 100mg twice a day
Forth week, Placebo twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
Placebo First, Then Cilostazol
First week, Placebo twice a day
Second week, Cilostazol 100mg twice a day
Third week, Placebo twice a day
Forth week, Cilostazol 100mg twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cilostazol for HFpEF
Baseline characteristics by cohort
| Measure |
Cilostazol First, Then Placebo
n=11 Participants
First week, Cilostazol 100mg twice a day
Second week, Placebo twice a day
Third week, Cilostazol 100mg twice a day
Forth week, Placebo twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
Placebo First, Then Cilostazol
n=12 Participants
First week, Placebo twice a day
Second week, Cilostazol 100mg twice a day
Third week, Placebo twice a day
Forth week, Cilostazol 100mg twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe Kansas City Cardiomyopathy Questionnaire contains 12 items that measure the effect of heart failure on health and quality of life. Total scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Outcome measures
| Measure |
Cilostazol
n=23 Participants
First week, Cilostazol 100mg twice a day
Second week, Placebo twice a day
Third week, Cilostazol 100mg twice a day
Forth week, Placebo twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
Placebo
n=23 Participants
First week, Placebo twice a day
Second week, Cilostazol 100mg twice a day
Third week, Placebo twice a day
Forth week, Cilostazol 100mg twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
|---|---|---|
|
KCCQ-12
|
47 units on a scale
Interval 32.0 to 52.0
|
39 units on a scale
Interval 29.0 to 48.0
|
SECONDARY outcome
Timeframe: 1st and 3rd weekBlood marker of heart failure severity \[pg/mL\], average of 2 time points 1st and 3rd week
Outcome measures
| Measure |
Cilostazol
n=23 Participants
First week, Cilostazol 100mg twice a day
Second week, Placebo twice a day
Third week, Cilostazol 100mg twice a day
Forth week, Placebo twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
Placebo
n=23 Participants
First week, Placebo twice a day
Second week, Cilostazol 100mg twice a day
Third week, Placebo twice a day
Forth week, Cilostazol 100mg twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
|---|---|---|
|
NTproBNP
|
375 pg/mL
Interval 68.0 to 974.0
|
448 pg/mL
Interval 154.0 to 1056.0
|
Adverse Events
Cilostazol
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Placebo
Serious events: 5 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cilostazol
n=23 participants at risk
First week, Cilostazol 100mg twice a day
Second week, Placebo twice a day
Third week, Cilostazol 100mg twice a day
Forth week, Placebo twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
Placebo
n=23 participants at risk
First week, Placebo twice a day
Second week, Cilostazol 100mg twice a day
Third week, Placebo twice a day
Forth week, Cilostazol 100mg twice a day
Cilostazol 100Mg Tab: Cilostazol Twice a Day
Placebo: Placebo
|
|---|---|---|
|
General disorders
Headache
|
13.0%
3/23 • Number of events 3 • 1 month
Data on non-serious adverse events was not collected
|
8.7%
2/23 • Number of events 2 • 1 month
Data on non-serious adverse events was not collected
|
|
General disorders
Nausea
|
13.0%
3/23 • Number of events 3 • 1 month
Data on non-serious adverse events was not collected
|
4.3%
1/23 • Number of events 1 • 1 month
Data on non-serious adverse events was not collected
|
|
General disorders
dizziness
|
4.3%
1/23 • Number of events 1 • 1 month
Data on non-serious adverse events was not collected
|
0.00%
0/23 • 1 month
Data on non-serious adverse events was not collected
|
|
General disorders
edema
|
0.00%
0/23 • 1 month
Data on non-serious adverse events was not collected
|
8.7%
2/23 • Number of events 2 • 1 month
Data on non-serious adverse events was not collected
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place