Cilostazol for HFpEF

NCT05126836 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CV-2020-29436
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (1)

• NTproBNP

  1st and 3rd week

Study Arms (2)

Cilostazol

OTHER

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

Placebo

OTHER

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

Interventions

Cilostazol 100Mg Tab DRUG

Cilostazol Twice a Day

Cilostazol; Placebo

Placebo DRUG

Placebo

Cilostazol; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 yrs
• LVEF ≥ 50% (on last assessment, \<2 years)
• Diagnosis of HFpEF or Shortness of breath with NYHA Class ≥ 2 and one of the following:
• pulmonary edema on chest imaging or documented on exam or on loop diuretics
• NTproBNP \>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)

You may not qualify if:

• \<18yo
• resting heart rate \>100/min
• patients with LVEF \<50%
• advanced end-stage heart failure,
• symptomatic COPD on home O2,
• uncontrolled severe HTN (SBP \>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,

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

M Health Fairview

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Aiad N, du Fay de Lavallaz J, Zhang MJ, Chaikijurajai T, Ye B, Nijjar PS, Lahiri JA, Martin CM, Alexy T, Meyer M. Cilostazol in patients with heart failure and preserved ejection fraction-The CLIP-HFpEF trial. ESC Heart Fail. 2025 Apr;12(2):1437-1446. doi: 10.1002/ehf2.15162. Epub 2024 Nov 17.

  PMID: 39552153 DERIVED

MeSH Terms

Interventions

Cilostazol

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Markus Meyer
• Organization: University of Minnesota

meye3249@umn.edu

612.625-9538

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: n-of-1 design

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 19, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)