Cilostazol for HFpEF

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure With Preserved Ejection Fraction

In brief

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

Key facts

Study ID

NCT05126836

Run by

University of Minnesota

People needed

25

Starts

2021-09-01

Expected to finish

2022-07-01

Last updated by the study team

2023-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,
• Patients on oral ketoconazole, itraconazole, fluconazole, miconazole, fluvoxamine, fluoxetine, nefazodone, sertraline, erythromycin, clarithromycin or azithromycin

Where it is running

• M Health Fairview — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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