A Phase 2 interventional study of Cilostazol 100Mg Tab and Placebo in Heart Failure With Preserved Ejection Fraction, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment
Determine if cilostazol improves symptoms and NTproBNP levels (heart failure blood marker) in heart failure with preserved ejection fraction (HFpEF) - a prevalent syndrome without targeted evidence-based treatment.
This will be assessed in a prospective 1-month single blinded study with 2 cross-overs n-of-1 study design with placebo and cilostazol
Heart failure (HF) is the #1 reason for hospital admissions. About half of the patients with HF have a preserved ejection fraction (HFpEF). There is no targeted evidence-based treatment for HFpEF. We recently reported that elevating the heart rate with pacemakers conveys clinical benefits e.g. reduction in heart failure symptoms, lowering filling pressures and an increase in walk distance. Cilostazol is a PDE3 inhibitor that increases the heart rate by about 5-8 beats per minute and has other potentially beneficial HFpEF effects such as peripheral vasodilation, lusitropic effects and dromotropic effects. By activating proteinkinase A, cilostazol may also phosphorylate titin, which may reduce myocardial stiffness.
n-of-1 study design using the standard dose cilostazol formulation of 100mg twice a day approved for peripheral vascular disease. The investigators and patients are blinded. The patients serve as their own controls with two crossovers (Week 1: cilostazol or placebo - Week 2: placebo or cilostazol - Week 3: cilostazol or placebo - Week 4: placebo or cilostazol).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 25 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of HFpEF or Shortness of breath with NYHA Class ≥ 2 and one of the following:
Exclusion Criteria:
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
Drug: Cilostazol 100Mg Tab · Drug: Placebo
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
Drug: Cilostazol 100Mg Tab · Drug: Placebo
Cilostazol Twice a Day
Placebo
KCCQ-12
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
Time frame: 4 weeks
NTproBNP
Blood marker of heart failure severity \[pg/mL\], average of 2 time points 1st and 3rd week
Time frame: 1st and 3rd week
| Milestone | Cilostazol First (1 Week), Then Placebo (1 Week) | Placebo First, Then Cilostazol |
|---|---|---|
| Started | 12 | 13 |
| Completed | 11 | 12 |
| Not completed | 1 | 1 |
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
| units on a scale | Cilostazol | Placebo |
|---|---|---|
| KCCQ-12 | 47 (32 to 52) | 39 (29 to 48) |
Blood marker of heart failure severity \[pg/mL\], average of 2 time points 1st and 3rd week
| pg/mL | Cilostazol | Placebo |
|---|---|---|
| NTproBNP | 375 (68 to 974) | 448 (154 to 1056) |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cilostazol | 3/23 (13%) | 3/23 (13%) | — |
| Placebo | 5/23 (21.7%) | 5/23 (21.7%) | — |
| Event | Cilostazol | Placebo |
|---|---|---|
| HeadacheGeneral disorders | 3/23 | 2/23 |
| NauseaGeneral disorders | 3/23 | 1/23 |
| edemaGeneral disorders | 0/23 | 2/23 |
| dizzinessGeneral disorders | 1/23 | 0/23 |
| Age, Categorical(Participants) | Cilostazol First, Then Placebo | Placebo First, Then Cilostazol | Total |
|---|---|---|---|
| <=18 years | 11 | 12 | 23 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cilostazol First, Then Placebo | Placebo First, Then Cilostazol | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 6 | 5 | 11 |
| Race (NIH/OMB)(Participants) | Cilostazol First, Then Placebo | Placebo First, Then Cilostazol | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 10 | 10 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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University of Minnesota