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Cilostazol for HFpEF

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cilostazol 100Mg Tab

Placebo

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

M Health Fairview

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Cilostazol first, then Placebo

Placebo first, then Cilostazol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

NTproBNP

Blood marker of heart failure severity [pg/mL]

Full Information

NCT ID

NCT05126836

First Posted

November 1, 2021

Last Updated

July 18, 2023

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT05126836

Brief Title

Cilostazol for HFpEF

Official Title

Cilostazol for HFpEF (Heart Failure With a Preserved Ejection Fraction)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

n-of-1 design

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cilostazol first, then Placebo

Arm Type

Other

Arm Description

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

Arm Title

Placebo first, then Cilostazol

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cilostazol 100Mg Tab

Intervention Description

Cilostazol Twice a Day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

KCCQ-12

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

NTproBNP

Description

Blood marker of heart failure severity [pg/mL]

Time Frame

1st week and 3rd week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

M Health Fairview

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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