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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06215911
Registration number
NCT06215911
Ethics application status
Date submitted
13/12/2023
Date registered
22/01/2024
Date last updated
1/07/2025
Titles & IDs
Public title
A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)
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Scientific 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
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Secondary ID [1]
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2023-508736-62
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Secondary ID [2]
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CRD-750-201
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Universal Trial Number (UTN)
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Trial acronym
Cycle-1-REF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Heart Failure With Reduced Ejection Fraction
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Cardiovascular Diseases
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Heart Diseases
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tovinontrine (CRD-750)
Treatment: Drugs - Placebo
Experimental: Tovinontrine (CRD-750) - low dose -
Experimental: Tovinontrine (CRD-750) - medium dose -
Experimental: Tovinontrine (CRD-750) - high dose -
Placebo comparator: Placebo -
Treatment: Drugs: Tovinontrine (CRD-750)
Tablets administered orally
Treatment: Drugs: Placebo
Tablets administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in biomarkers from Baseline to Week 12 - NT-proBNP
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Assessment method [1]
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The percent change in plasma NT-proBNP (Dose Cohort 3 versus placebo) will be calculated from Baseline to Week 12 using an ANCOVA model. If a statistically significant reduction in plasma NT-proBNP is detected (2-sided alpha=0.05), the next analysis will compare Dose 2 versus placebo at the (2-sided alpha = 0.05 level). If statistically significant, the next analysis will compare Dose 1 versus placebo.
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [1]
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Change in biomarkers at Week 12 by treatment group - NT-proBNP
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Assessment method [1]
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The percent change in plasma NT-proBNP will be calculated by treatment group from Baseline to Week 12. The correlation of plasma concentration with percent change in plasma NT-proBNP will be evaluated using Pearson's correlation coefficient.
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [2]
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Change in biomarkers at week 12 by treatment group - cGMP
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Assessment method [2]
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The percent change in urine and plasma cGMP from Baseline to Week 12 will be analyzed using ANCOVA and MMRM models by treatment group.
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Timepoint [2]
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Baseline to Week 12
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Secondary outcome [3]
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Change in biomarkers at week 12 by treatment group - BNP
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Assessment method [3]
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The percent change in BNP from Baseline to Week 12 will be analyzed using an ANCOVA model to evaluate individual dose comparisons.
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Timepoint [3]
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Baseline to Week 12
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Secondary outcome [4]
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Change in the biomarker ratio at Week 12 - NT-proBNP
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Assessment method [4]
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The change in the urine and plasma cGMP to NT-proBNP ratio at week 12 will be calculated for each treatment group
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Timepoint [4]
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Baseline to Week 12
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Secondary outcome [5]
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Change in the biomarker ratio at Week 12 - BNP
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Assessment method [5]
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The percent change in the urine and plasma cGMP to BNP ratio from Baseline to Week 12 will be calculated for each treatment group
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Timepoint [5]
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Baseline to Week 12
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Secondary outcome [6]
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Kansas City Cardiomyopathy Questionnaire-23-Clinical Summary Score
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Assessment method [6]
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Scaled 0 to 100 where lower scores represent worse health status than higher scores
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Timepoint [6]
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Baseline to Week 12
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Secondary outcome [7]
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Kansas City Cardiomyopathy Questionnaire 23- Overall Summary Score
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Assessment method [7]
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Scaled 0 to 100 where lower scores represent worse health status than higher scores
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Timepoint [7]
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Baseline to Week 12
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Secondary outcome [8]
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New York Heart Association Classification
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Assessment method [8]
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Class I to IV are possible with a higher classification representing worsening heart failure status
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Timepoint [8]
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Baseline to Week 12
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Secondary outcome [9]
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Treatment Emergent Adverse Events (TEAEs)
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Assessment method [9]
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The number of participants with TEAEs including drug related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation will be assessed. The incidence of AEs will be presented by system organ class and preferred term according to the Medical Dictionary of Regulatory Activities.
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Timepoint [9]
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Baseline to Week 12
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Secondary outcome [10]
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Changes in laboratory assessments
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Assessment method [10]
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Number of participants with normal/ abnormal values at Baseline compared to normal/ abnormal values post-Baseline will be assessed for hematology, serum chemistry and urinalysis. Descriptive statistics of clinical laboratory assessment results and the change from Baseline will be presented by dose cohort and visit.
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Timepoint [10]
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Baseline to Week 12
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Secondary outcome [11]
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Changes in vital sign measurement: systolic and diastolic blood pressure
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Assessment method [11]
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Change from Baseline to Week 12 will be assessed for systolic and diastolic blood pressure (mmHg). Descriptive statistics of vital signs and the change from Baseline will be presented by dose cohort and visit.
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Timepoint [11]
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Baseline to Week 12
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Secondary outcome [12]
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Changes in vital sign measurement: pulse rate
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Assessment method [12]
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The change from Baseline to Week 12 will be assessed for pulse rate (bpm). Descriptive statistics of vital signs and the change from Baseline will be presented by dose cohort and visit.
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Timepoint [12]
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Baseline to Week 12
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Secondary outcome [13]
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Changes in vital sign measurement: respiratory rate
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Assessment method [13]
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The change from Baseline to Week 12 will be assessed for respiratory rate (breaths/min). Descriptive statistics of vital signs and the change from Baseline will be presented by dose cohort and visit.
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Timepoint [13]
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Baseline to Week 12
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Secondary outcome [14]
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Changes in vital sign measurement: body temperature
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Assessment method [14]
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The change from Baseline to Week 12 will be assessed for body temperature. Descriptive statistics of vital signs and the change from Baseline will be presented by dose cohort and visit.
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Timepoint [14]
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Baseline to Week 12
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Secondary outcome [15]
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Changes in physical examination
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Assessment method [15]
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General physical exams will be carried out to detect any abnormalities in the cardiovascular, respiratory, and other body systems. Non-pre-existing abnormal physical examinations will be summarized by dose cohort and visit.
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Timepoint [15]
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Baseline to Week 12
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Secondary outcome [16]
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Changes in 12-lead electrocardiogram (ECG) measurements
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Assessment method [16]
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Number of participants who have normal/abnormal 12-lead ECG measurements at Baseline will be compared to normal/abnormal 12-lead ECG measurement post Baseline. Descriptive statistics of 12-lead ECG data and the change from baseline will be presented by dose cohort and visit.
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Timepoint [16]
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Baseline to Week 12
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Secondary outcome [17]
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Assessment of pharmacokinetics (PK): PK effect on NT-proBNP
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Assessment method [17]
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The plasma concentrations will be evaluated in the PK Population. The plasma concentration of tovinontrine will be summarized by dose cohort and visit. The correlation of plasma concentration with percent change in plasma NT-proBNP will be evaluated using Pearson's correlation coefficient.
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Timepoint [17]
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Baseline to Week 12
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Secondary outcome [18]
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Assessment of pharmacokinetics (PK): PK effect on plasma cGMP
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Assessment method [18]
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The plasma concentrations will be evaluated in the PK Population. The plasma concentration of tovinontrine will be summarized by dose cohort and visit. The correlation of plasma concentration with percent change in plasma cGMP will be evaluated using Pearson's correlation coefficient.
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Timepoint [18]
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Baseline to Week 12
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Eligibility
Key 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% 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;
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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;
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Cardurion Investigative Site - Southport
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Recruitment hospital [2]
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Cardurion Investigative Site - Chermside
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Recruitment hospital [3]
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Cardurion Investigative Site - Perth
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Recruitment postcode(s) [1]
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4222 - Southport
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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- Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Illinois
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Louisiana
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Maryland
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Missouri
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Kraków
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Handlová
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Košice
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Nitra
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Murcia
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Alicante
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Spain
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State/province [90]
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Córdoba
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Spain
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Madrid
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Spain
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Málaga
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Spain
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State/province [93]
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Santiago De Compostela
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Country [94]
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Spain
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State/province [94]
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Sevilla
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Country [95]
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Spain
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State/province [95]
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Valencia
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Country [96]
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Taiwan
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State/province [96]
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Kaohsiung City
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Country [97]
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Taiwan
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State/province [97]
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New Taipei City
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Country [98]
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Taiwan
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State/province [98]
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Taichung
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Country [99]
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Taiwan
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State/province [99]
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Taipei
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United Kingdom
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Manchester
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United Kingdom
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Bridgend
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Country [102]
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United Kingdom
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State/province [102]
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Chichester
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Country [103]
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United Kingdom
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State/province [103]
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Dundee
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United Kingdom
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State/province [104]
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Glasgow
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United Kingdom
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State/province [105]
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Harrow
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United Kingdom
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State/province [106]
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Isleworth
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Country [107]
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United Kingdom
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State/province [107]
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London
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Country [108]
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United Kingdom
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State/province [108]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cardurion Pharmaceuticals, Inc.
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Address
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Ethics approval
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Summary
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 reduced ejection fraction.
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Trial website
https://clinicaltrials.gov/study/NCT06215911
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gail Berman
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Senior VP Head, Clinical Development Cardurion
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Email
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Contact person for public queries
Name
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Gail Berman
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Address
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Phone
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617-863-8088
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06215911
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