Cilostazol for HFpEF

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota
• Treatments: Cilostazol

Criteria

Inclusion Criteria:

• >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:

1. pulmonary edema on chest imaging or documented on exam or on loop diuretics

2. NTproBNP >400 ng/ml in the last 24 months

3. HFpEF>50% hospitalization in the last 3 years

4. 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:

• <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