Heart Failure With Preserved Ejection FractionPhase 2NCT05126836
Cilostazol for HFpEF
A Phase 2 study testing Cilostazol 100Mg Tab in people with Heart Failure With Preserved Ejection Fraction, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Cilostazol 100Mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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)
Who cannot join
- <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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cilostazol for HFpEF (Heart Failure With a Preserved Ejection Fraction)
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
Read the 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).
- Being tested
- Cilostazol 100Mg Tab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol 100Mg TabDrug
Cilostazol Twice a Day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Other | 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 Receives: Drug: Cilostazol 100Mg Tab; Drug: Placebo |
| Placebo | Other | 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 Receives: Drug: Cilostazol 100Mg Tab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
NTproBNP
Blood marker of heart failure severity [pg/mL], average of 2 time points 1st and 3rd week
Measured: 1st and 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Sep 2021
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- n-of-1 design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126836
- Sponsor's protocol ID
- CV-2020-29436
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2021
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39552153
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cilostazol for HFpEF (Heart Failure With a Preserved Ejection Fraction)
- ClinicalTrials.gov ID
- NCT05126836
- Acronym / sponsor ID
- CV-2020-29436
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- n-of-1 design
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Other | Drug: Cilostazol 100Mg Tab, Drug: PlaceboFirst 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 |
| Placebo | Other | Drug: Cilostazol 100Mg Tab, Drug: PlaceboFirst 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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:
Key exclusion criteria (16 listed)
- <18yo
- resting heart rate >100/min
- patients with LVEF <50%
- advanced end-stage heart failure,
- symptomatic COPD on home O2,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilostazol 100Mg TabCilostazol Twice a Day | Drug | Cilostazol, Placebo |
| PlaceboPlacebo | Drug | Cilostazol, Placebo |
Primary outcome
KCCQ-12
Time frame: 4 weeks
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
1 secondary outcome
NTproBNP
Time frame: 1st and 3rd week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39552153Aiad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cilostazol 100Mg Tab in people with Heart Failure With Preserved Ejection Fraction, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KCCQ-12 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05126836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.