Heart Failure Clinical Trial

Cilostazol for HFpEF

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

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Full Description

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).

View Eligibility Criteria

Eligibility 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:

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)

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT05126836

Recruitment Status:

Completed

Sponsor:

University of Minnesota

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There is 1 Location for this study

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M Health Fairview
Minneapolis Minnesota, 55455, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT05126836

Recruitment Status:

Completed

Sponsor:


University of Minnesota

How clear is this clinincal trial information?

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