Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Preserved Ejection Fraction (Cycle-2-PEF) (Cycle-2-PEF)

August 28, 2026 updated by: Cardurion Pharmaceuticals, Inc.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction

The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Chermside, Australia
        • Cardurion Investigative Site
  • Belgium
      • Bruges, Belgium, 8000
        • Cardurion Investigative Site
      • Sint-Niklaas, Belgium, 9100
        • Cardurion Investigative Site
  • Bulgaria
      • Burgas, Bulgaria, 8008
        • Cardurion Investigative Site
      • Gabrovo, Bulgaria, 5300
        • Cardurion Investigative Site
      • Plovdiv, Bulgaria, 4002
        • Cardurion Investigative Site
      • Plovdiv, Bulgaria, 4003
        • Cardurion Investigative Site
      • Rousse, Bulgaria, 7000
        • Cardurion Investigative Site
      • Sofia, Bulgaria, 1000
        • Cardurion Investigative Site
      • Stara Zagora, Bulgaria, 6000
        • Cardurion Investigative Site
  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Cardurion Investigative Site
      • Hamilton, Ontario, Canada, L8L 2X2
        • Cardurion Investigative Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Cardurion Investigative Site
      • Montreal, Quebec, Canada
        • Cardurion Investigative Site
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Cardurion Investigative Site
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Cardurion Investigative Site
  • Czechia
      • Hradec Králové, Czechia, 500 02
        • Cardurion Investigative Site
      • Hradec Králové, Czechia, 50005
        • Cardurion Investigative Site
      • Prague, Czechia, 128 02
        • Cardurion Investigative Site
  • Germany
      • Dresden, Germany, 01067
        • Cardurion Investigational Site
      • Magdeburg, Germany, 39120
        • Cardurion Investigative Site
    • Brandenburg
      • Elsterwerda, Brandenburg, Germany, 04910
        • Cardurion Investigative Site
    • Lower Saxony
      • Papenburg, Lower Saxony, Germany, 26871
        • Cardurion Investigative Site
    • State of Berlin
      • Brandenburg, State of Berlin, Germany, 10787
        • Cardurion Investigative Site
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Cardurion Investigative Site
      • Budapest, Hungary, H-1122
        • Cardurion Investigative Site
      • Gyöngyös, Hungary, 3200
        • Cardurion Investigative Site
      • Hatvan, Hungary, 3000
        • Cardurion Investigative Site
      • Orosháza, Hungary, 5900
        • Cardurion Investigative Site
  • Italy
      • Milan, Italy, 20138
        • Cardurion Investigative Site
  • Netherlands
      • Eindhoven, Netherlands, 5504 DL
        • Cardurion Investigative Site
      • Groningen, Netherlands, 9713 AP
        • Cardurion Investigative Site
      • Hardenberg, Netherlands, 7772 SE
        • Cardurion Investigative Site
      • Sneek, Netherlands, 8601 ZR
        • Cardurion Investigative Site
      • Zutphen, Netherlands, 7207 AE
        • Cardurion Investigative Site
  • New Zealand
      • Dunedin, New Zealand
        • Cardurion Investigative Site
  • Poland
      • Grodzisk Mazowiecki, Poland, 05-825
        • Cardurion Investigative Site
      • Lodz, Poland, 92-213
        • Cardurion Investigative Site
      • Lublin, Poland, 20-011
        • Cardurion Investigative Site
      • Sopot, Poland, 81-717
        • Cardurion Investigative Site
      • Torun, Poland, 87-100
        • Cardurion Investigative Site
      • Warsaw, Poland
        • Cardurion Investigative Site
      • Wroclaw, Poland, 50-556
        • Cardurion Investigative Site
      • Wroclaw, Poland, 50-981
        • Cardurion Investigative Site
  • Spain
      • Córdoba, Spain, 14004
        • Cardurion Investigative Site
      • Málaga, Spain, 29010
        • Cardurion Investigative Site
      • Santiago de Compostela, Spain, 15706
        • Cardurion Investigative Site
      • Seville, Spain, 41009
        • Cardurion Investigative Site
      • Valencia, Spain, 46026
        • Cardurion Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan
        • Cardurion Investigative Site
      • Taipei, Taiwan
        • Cardurion Investigative Site
      • Taipei County, Taiwan
        • Cardurion Investigative Site
      • Taoyuan, Taiwan
        • Cardurion Investigative Site
  • United Kingdom
      • Bridgend, United Kingdom, CF31 1RQ
        • Cardurion Investigative Site
      • Chichester, United Kingdom, PO19 6SE
        • Cardurion Investigative Site
      • Dundee, United Kingdom, DD1 9SY
        • Cardurion Investigative Site
      • Glasgow, United Kingdom, G81 4DY
        • Cardurion Investigative Site
      • Harrow, United Kingdom, HA1 3UJ
        • Cardurion Investigative Site
      • Isleworth, United Kingdom, TW7 6AF
        • Cardurion Investigative Site
      • London, United Kingdom, SE5 9RS
        • Cardurion Investigative Site
      • London, United Kingdom, W1T 7HA
        • Cardurion Investigative Site
      • Southampton, United Kingdom, SO16 6YD
        • Cardurion Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Cardurion Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Cardurion Investigative Site
    • California
      • Orange, California, United States, 92868
        • Cardurion Investigative Site
      • Torrance, California, United States, 90502
        • Cardurion Investigative Site
      • Van Nuys, California, United States, 91405
        • Cardurion Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Cardurion Investigative Site
      • Miami, Florida, United States, 33137
        • Cardurion Investigative Site
    • Illinois
      • Hazel Crest, Illinois, United States, 60429
        • Cardurion Investigative Site
      • Peoria, Illinois, United States, 61636
        • Cardurion Investigative Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cardurion Investigative Site
      • Covington, Louisiana, United States, 70433
        • Cardurion Investigative Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Cardurion Investigative Site
    • New York
      • Buffalo, New York, United States, 14215
        • Cardurion Investigative Site
      • New York, New York, United States, 10019
        • Cardurion Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cardurion Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Cardurion Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Cardurion Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Cardurion Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232-7601
        • Cardurion Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Cardurion Investigative Site
      • McKinney, Texas, United States, 75069
        • Cardurion Investigative Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Cardurion Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is an adult male or female patient ≥ 18 years of age

  • Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following:

    • At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity;
    • At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or
    • Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months.
  • Has ejection fraction (EF) >40% and left atrial enlargement by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
  • Has NT-proBNP level ≥ 300 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT proBNP level of ≥500 pg/mL at the time of Screening;
  • Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgment, for a minimum of 4 weeks prior to the time of Screening and during the Screening Period, with no planned changes after randomization; Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period;

Exclusion Criteria:

  • Has documented EF ≥ 60% by TTE within 6 months of the time of Screening or during the Screening Period;
  • Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 60 days of the time of Screening or during the Screening Period;
  • Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration;
  • Has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study;
  • Has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of Screening or during the Screening Period;
  • Has had a prior or planned orthotopic heart transplantation;
  • Has presence of or plan for mechanical circulatory support;

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo Comparator
Drug: Placebo
Tablet administered orally
Experimental: Tovinontrine (CRD-750)
Experimental: Tovinontrine (CRD-750)
Drug: Tovinontrine (CRD-750)
Tablet administered orally
Other Names:
  • IMR-687

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in biomarkers from Baseline to Week 12 - NT-proBNP
Time Frame: Baseline to Week 12
The percent change in plasma NT-proBNP from Baseline to Week 12.
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in biomarkers at week 12 by treatment group - cGMP
Time Frame: Baseline to Week 12
The percent change in urine and plasma cGMP from Baseline to Week 12.
Baseline to Week 12
Change in biomarkers at week 12 by treatment group - BNP
Time Frame: Baseline to Week 12
The percent change in BNP from Baseline to Week 12.
Baseline to Week 12
Change in the biomarker ratio at Week 12 - NT-proBNP
Time Frame: Baseline to Week 12
The percent change in the urine and plasma cGMP to NT-proBNP ratio at week 12.
Baseline to Week 12
Change in the biomarker ratio at Week 12 - BNP
Time Frame: Baseline to Week 12
The percent change in the urine and plasma cGMP to BNP ratio from Baseline to Week 12.
Baseline to Week 12
The change from baseline in the KCCQ-23-CSS
Time Frame: Baseline to Week 12
The proportion of patients with a ≥5, 10, and 20-point improvement in the KCCQ-23-CSS at Week 12
Baseline to Week 12
New York Heart Association (NYHA) classification at Week 12
Time Frame: Week 12
The post-baseline NYHA classification at Week 12
Week 12
Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to Week 12
The number of participants with TEAEs including drug related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation.
Baseline to Week 12
The change from baseline in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
Time Frame: Baseline to Week 12
Scaled 0 to 100 where lower scores represent worse health status than higher scores
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardurion Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Brandon Atkins, VP Head, Clinical Development Cardurion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRD-750-202
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-508737-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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