Phase 2
N=25
Cilostazol for HFpEF
Heart Failure With Preserved Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT05126836 ↗Enrolled (actual)
25
Serious AEs
17.4%
Results posted
Dec 2023
Primary outcome: Primary: KCCQ-12 — 47; 39 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cilostazol 100Mg Tab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY KCCQ-12 |
47; 39 | — |
| SECONDARY NTproBNP |
375; 448 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- >18 yrs
- LVEF ≥ 50% (on last assessment, 400 ng/ml in the last 24 months
- HFpEF>50% hospitalization in the last 3 years
- Qualitative echo: > mild diastolic dysfunction on echo report and > mild left ventricular hypertrophy and left atrial dilation or quantitative echo: left ventricular hypertrophy [men ≥115 g/m², women ≥95 g/m² or relative wall thickness >0.42 or any LV wall thickness >1.2cm and has LA dilation (>28ml/m2)
Exclusion Criteria
- 100/min
- patients with LVEF 160/100 mmHg)
- patients with life expectancy <6 months,
- end-stage liver cirrhosis,
- more than moderate valve disease,
- infiltrative myocardial disease
- constrictive pericarditis or myocarditis,
- patients unable to participate in follow up,
- pregnant patients or patients without reliable contraceptive agent for the duration of study participation),
- left ventricular outflow tract obstruction,
- bleeding dyscrasias, blood dyscrasias,
- Patients on oral ketoconazole, itraconazole, fluconazole, miconazole, fluvoxamine, fluoxetine, nefazodone, sertraline, erythromycin, clarithromycin or azithromycin
Data sourced from ClinicalTrials.gov (NCT05126836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.