MedDataX Logo

Cilostazol for HFpEF

NCT ID: NCT05126836

Last Updated: 2023-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure With Preserved Ejection Fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

n-of-1 design
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cilostazol

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

Group Type OTHER

Cilostazol 100Mg Tab

Intervention Type DRUG

Cilostazol Twice a Day

Placebo

Intervention Type DRUG

Placebo

Placebo

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

Group Type OTHER

Cilostazol 100Mg Tab

Intervention Type DRUG

Cilostazol Twice a Day

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cilostazol 100Mg Tab

Cilostazol Twice a Day

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

M Health Fairview

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39552153 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CV-2020-29436

Identifier Type: -

Identifier Source: org_study_id