A Phase 2 Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fractio

Phase 1

• Conditions: Heart failure (HF) with reduced ejection fraction (HFrEF); MedDRA version: 26.1Level: LLTClassification code: 10078289Term: Heart failure with reduced ejection fraction Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508736-62-00
• Lead Sponsor: Cardurion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-19
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Is an adult male or female patient 18 years of age or older, at the time of Screening, Has evidence in the medical history supporting a diagnosis of clinical heart failure (HF) syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening, 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 =1000 pg/mL at the time of Screening, Is on stable optimized doses of guideline-directed HF therapy 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 (with the exception of diuretics) within the 3 months prior to the time of Screening or during the Screening Period, Other protocol-defined criteria apply

Exclusion Criteria

Has documented EF =40% by TTE within 6 months of the time of Screening or during the Screening Period, Has the presence of or plan for mechanical circulatory support, Has any of the following findings at Screening: oA clinically significant abnormal finding on ECG considered by the Investigator to pose a risk to the safety of the patient; AND/OR oA QTcF interval of >500 msec AND/OR oA family history of Long QT Syndrome AND/OR oUtilization of concomitant therapies known to increase the risk of torsade de pointes, Other protocol-defined criteria apply, Has known bleeding diathesis, 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, diuretics) or routinely scheduled ultrafiltration, Has any clinically significant abnormal findings on physical examination as judged by the Investigator (or designee), AND/OR vital signs recorded at Screening of the following: o Average systolic blood pressure after a triplicate recording of <90 mmHg or =180 mmHg; o Average diastolic blood pressure after a triplicate recording of =90 mmHg; or o Heart rate <45 or >90 beats per minute., Has elective interventions (eg, percutaneous coronary intervention, device implantation, 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 clinical suspicion of infiltrative cardiomyopathy (eg, amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease, Has had prior or planned orthotopic heart transplantation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified