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A Phase 2 Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction
EU CTIS ID: 2023-508737-13-00
What this study is testing
To evaluate the effect of tovinontrine on N-terminal pro b-type natriuretic peptide (NT-proBNP) at 12 weeks compared to placebo in adult patients with HFpEF.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is an adult male or female patient ≥18 years of age, or adult age as per country guidelines, at the time of Screening.
- Has a 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% 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 ≥500 pg/mL at the time of Screening
- Is on stable optimized doses of guideline-directed HF therapy, per Investigator’s clinical judgment.
- 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 and is on stable optimized doses of all HF therapies, including diuretics, for a minimum of 4 weeks prior to the time of Screening and during the Screening Period, with no planned changes after randomization
You likely can't join if
- Has documented EF ≥60% by TTE within 6 months of the time of Screening or during the Screening Period
- Has had prior or planned orthotopic heart transplantation
- Has the presence of or plan for mechanical circulatory support
- Has any of the following findings at Screening: A clinically significant abnormal finding on electrocardiogram (ECG) considered by the Investigator to pose a risk to the safety of the patient; and/or oPersonal or family history of Long QT syndrome; and/or A QTcF interval of >500 msec; and/or oUtilization of concomitant therapies known to increase the risk of torsade de pointe
- Has known bleeding diathesis
- Other protocol-defined criteria apply
See the full eligibility criteria
Who can join
- Is an adult male or female patient ≥18 years of age, or adult age as per country guidelines, at the time of Screening.
- Has a 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% 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 ≥500 pg/mL at the time of Screening
- Is on stable optimized doses of guideline-directed HF therapy, per Investigator’s clinical judgment.
- 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 and is on stable optimized doses of all HF therapies, including diuretics, for a minimum of 4 weeks prior to the time of Screening and during the Screening Period, with no planned changes after randomization
- Other protocol-defined criteria apply
What rules you out
- Has documented EF ≥60% by TTE within 6 months of the time of Screening or during the Screening Period
- Has had prior or planned orthotopic heart transplantation
- Has the presence of or plan for mechanical circulatory support
- Has any of the following findings at Screening: A clinically significant abnormal finding on electrocardiogram (ECG) considered by the Investigator to pose a risk to the safety of the patient; and/or oPersonal or family history of Long QT syndrome; and/or A QTcF interval of >500 msec; and/or oUtilization of concomitant therapies known to increase the risk of torsade de pointe
- Has known bleeding diathesis
- Other protocol-defined criteria apply
- 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, IV iron, or 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: - Average systolic blood pressure after a triplicate recording of <90 mmHg or ≥180 mmHg; - Average diastolic blood pressure after a triplicate recording of >90 mmHg; or - Heart rate <45 or >90 beats per minute.
- Has elective interventions (eg, percutaneous coronary intervention, de novo device implantations, percutaneous structural heart disease interventions, or major cardiac or non-cardiac surgery) planned to occur during study participation or has undergone this elective procedure <12 weeks prior to Screening.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.