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Not recruiting
Phase 2

Tovinontrine

Sponsor:

Cardurion Pharmaceuticals, Inc.

Code:

NCT06215586

Conditions

Heart Failure

Heart Failure Preserved Ejection Fraction

Cardiovascular Diseases

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tovinontrine (CRD-750

Placebo

Study Details

Brief summary:

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

Conditions

Heart Failure

Heart Failure Preserved Ejection Fraction

Cardiovascular Diseases

Heart Diseases

Study ID

NCT06215586

Start date

Feb 13, 2024

Status verified date

May, 2025

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tovinontrine (CRD-750)

placebo comparator: Placebo

Interventions

Tovinontrine (CRD-750

Tablets administered orally

Placebo

Tablets administered orally

Primary outcome measure

  • Change in biomarkers from Baseline to Week 12 - NT-proBNP [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Gail Berman

617-863-8088info@cardurion.com

Locations

Cardurion Investigative Site

Recruiting

Birmingham, Alabama, United States, 35233

Cardurion Investigative Site

Recruiting

Little Rock, Arkansas, United States, 72204

Cardurion Investigative Site

Recruiting

Orange, California, United States, 92868

Cardurion Investigative Site

Recruiting

Torrance, California, United States, 90502

Cardurion Investigative Site

Recruiting

Van Nuys, California, United States, 91405

Cardurion Investigative Site

Recruiting

Jacksonville, Florida, United States, 32216

Cardurion Investigative Site

Recruiting

Miami, Florida, United States, 33137

Cardurion Investigative Site

Recruiting

Hazel Crest, Illinois, United States, 60429

Cardurion Investigative Site

Recruiting

Peoria, Illinois, United States, 61636

Cardurion Investigative Site

Recruiting

Alexandria, Louisiana, United States, 71301

Cardurion Investigative Site

Recruiting

Covington, Louisiana, United States, 70433

Cardurion Investigative Site

Recruiting

Saint Louis, Missouri, United States, 63110

Cardurion Investigative Site

Recruiting

Buffalo, New York, United States, 14215

Cardurion Investigative Site

Recruiting

New York, New York, United States, 10019

Cardurion Investigative Site

Recruiting

Cleveland, Ohio, United States, 44195

Cardurion Investigative Site

Recruiting

Oklahoma City, Oklahoma, United States, 73135

Cardurion Investigative Site

Recruiting

Portland, Oregon, United States, 97225

Cardurion Investigative Site

Recruiting

Rapid City, South Dakota, United States, 57701

Cardurion Investigative Site

Recruiting

Nashville, Tennessee, United States, 37232-7601

Cardurion Investigative Site

Recruiting

Dallas, Texas, United States, 75246

Cardurion Investigative Site

Recruiting

McKinney, Texas, United States, 75069

Cardurion Investigative Site

Recruiting

Burlington, Vermont, United States, 05401

Cardurion Investigative Site

Recruiting

Cambridge, Ontario, Canada, N1R 6V6

Cardurion Investigative Site

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Cardurion Investigative Site

Recruiting

Chicoutimi, Quebec, Canada, G7H 7K9

Cardurion Investigative Site

Recruiting

Montréal, Quebec, Canada

Cardurion Investigative Site

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

Cardurion Investigative Site

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

More Information

Sponsor

Cardurion Pharmaceuticals, Inc.

Last update posted

May 23, 2025

Last verified

May, 2025

Keywords

  • PDE9
  • PED9 Inhibitor
  • Heart Failure
  • CRD-750
  • Tovinontrine
  • HFpEF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Cardurion Pharmaceuticals, Inc. on 2025-05-23.