COMPLETED

A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)

Conditions

Heart Failure Heart Failure With Reduced Ejection Fraction Cardiovascular Diseases Heart Diseases PDE9 PED9 Inhibitor CRD-750 Tovinontrine HFrEF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 reduced ejection fraction.

Official Title

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

Quick Facts

Study Start:2024-02-13

Study Completion:2025-10-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06215911

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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% by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening; * Has NT-proBNP level ≥ 600 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 ≥ 1000 pg/mL at the time of Screening; * Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgement, for a minimum of 4 weeks prior to the time of Screening and during Screening, 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;	* Has a documented EF \>40% 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;

Inclusion Criteria

Exclusion 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% by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
* Has NT-proBNP level ≥ 600 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 ≥ 1000 pg/mL at the time of Screening;
* Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgement, for a minimum of 4 weeks prior to the time of Screening and during Screening, 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;

* Has a documented EF \>40% 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;

Contacts and Locations

Principal Investigator

Gail Berman

STUDY_DIRECTOR

Senior VP Head, Clinical Development Cardurion

Study Locations (Sites)

Cardurion Investigative Site

Birmingham, Alabama, 35233

United States

Cardurion Investigative Site

Little Rock, Arkansas, 72204

United States

Cardurion Investigative Site

Beverly Hills, California, 90211

United States

Cardurion Investigative Site

Orange, California, 92868

United States

Cardurion Investigative Site

Torrance, California, 90502

United States

Cardurion Investigative Site

Van Nuys, California, 91405

United States

Cardurion Investigative Site

Jacksonville, Florida, 32216

United States

Cardurion Investigative Site

Miami, Florida, 33137

United States

Cardurion Investigative Site

Hazel Crest, Illinois, 60429

United States

Cardurion Investigative Site

Peoria, Illinois, 61636

United States

Cardurion Investigative Site

Alexandria, Louisiana, 71301

United States

Cardurion Investigative Site

Covington, Louisiana, 70433

United States

Cardurion Investigative Site

Baltimore, Maryland, 21201

United States

Cardurion Investigative Site

St Louis, Missouri, 63110

United States

Cardurion Investigative Site

Omaha, Nebraska, 68198

United States

Cardurion Investigative Site

Buffalo, New York, 14215

United States

Cardurion Investigative Site

New York, New York, 10025

United States

Cardurion Investigative Site

Cleveland, Ohio, 44195

United States

Cardurion Investigative Site

Oklahoma City, Oklahoma, 73135

United States

Cardurion Investigative Site

Rapid City, South Dakota, 57701

United States

Cardurion Investigative Site

Nashville, Tennessee, 37232

United States

Cardurion Investigative Site

Dallas, Texas, 75226

United States

Cardurion Investigative Site

McKinney, Texas, 75069

United States

Cardurion Investigative Site

Burlington, Vermont, 05401

United States

Cardurion Investigative Site

Seattle, Washington, 98195

United States

Cardurion Investigative Site

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Cardurion Pharmaceuticals, Inc.

Gail Berman, STUDY_DIRECTOR, Senior 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 Registration Dates

Study Start Date2024-02-13

Study Completion Date2025-10-10

Study Record Updates

Study Start Date2024-02-13

Study Completion Date2025-10-10

Terms related to this study

Keywords Provided by Researchers

PDE9
PED9 Inhibitor
Heart Failure
CRD-750
Tovinontrine
HFrEF

Additional Relevant MeSH Terms

Heart Failure
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases
Heart Diseases