CardioNext® -IUO for Danicamtiv Phase 2b/3, DAN301 Study

CardioNext® -IUO for Danicamtiv Phase 2b/3, DAN301 Study - CardioNext® -IUO for Danicamtiv Phase 2b/3, DAN301 Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58374

Enrollment

Registered

2025-10-16

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated cardiomyopathy Weakened and enlarged heart muscle

Interventions

The CardioNext®-IUO is a qualitative genetic test intended for identifying and classifying genetic variants linked to cardiomyopathy. It analyzes a 92-gene panel—including SNVs, small deletions and in

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Provide inform consent • Provide specimen for genetic testing • Selected by Kardigan Inc. for genetic testing

Exclusion criteria

Exclusion criteria: • Failure to provide informed consent • Participants with previous allogeneic bone marrow transplant • Participants Non-leukocyte depleted whole blood transfusion in 120 days of providing the genetic sample

Design outcomes

Primary

Measure	Time frame
Performance Evaluation Study Estimands/ Endpoints: 1.Determination and confirmation of MYH7 and TTN variants and mutations with an analytical sensitivity and specificity >99% Clinical genetic test results report in the context of test indication with comprehensive information on detected variants meeting detection QC metrics of: Q score < 30; coverage < 20 reads; an alternate allele fraction < 10% and variant classification (Pathogenic variant (P); Variant, likely pathogenic (VLP); Variant of unknown significance (VUS)) 2.Positive Predictive Value (PPV) and Negative Predictive Value (NPV) ratio • PPV = TP / (TP + FP) Probability that a positive test indicates true disease (DCM) caused by MHY7 and TTN. • NPV = TN / (TN + FN) Probability that a negative test indicates absence of disease (DCM) caused by MHY7 and TTN.Performance Evaluation Study Estimands/ Endpoints: 1.Determination and confirmation of other genes, variants and mutations associated with DCM with an analytical sensitivity and specificity >99% Clinical genetic test results report in the context of test indication with comprehensive information on detected variants from other genes associated with DCM meeting detection QC metrics of: Q score < 30; coverage < 20 reads; an alternate allele fraction < 10% and variant classification (Pathogenic variant (P); Variant, likely pathogenic (VLP); Variant of unknown significance (VUS)) 2.Positive Predictive Value (PPV) and Negative Predictive Value (NPV) ratio • PPV = TP / (TP + FP) Probability that a positive test indicates true disease (DCM) caused by other genes than MHY7 and TTN. • NPV = TN / (TN + FN) Probability that a negative test indicates absence of disease (DCM) caused by other genes. 3. Detection rate ratio of MYH7 and TTN versus other genes/variants associated with DCM with an analytical sensitivity and specificity >99%	—

Measure

Time frame

Performance Evaluation Study Estimands/ Endpoints: 1.Determination and confirmation of MYH7 and TTN variants and mutations with an analytical sensitivity and specificity >99% Clinical genetic test results report in the context of test indication with comprehensive information on detected variants meeting detection QC metrics of: Q score < 30; coverage < 20 reads; an alternate allele fraction < 10% and variant classification (Pathogenic variant (P); Variant, likely pathogenic (VLP); Variant of unknown significance (VUS)) 2.Positive Predictive Value (PPV) and Negative Predictive Value (NPV) ratio • PPV = TP / (TP + FP) Probability that a positive test indicates true disease (DCM) caused by MHY7 and TTN. • NPV = TN / (TN + FN) Probability that a negative test indicates absence of disease (DCM) caused by MHY7 and TTN.Performance Evaluation Study Estimands/ Endpoints: 1.Determination and confirmation of other genes, variants and mutations associated with DCM with an analytical sensitivity and specificity >99% Clinical genetic test results report in the context of test indication with comprehensive information on detected variants from other genes associated with DCM meeting detection QC metrics of: Q score < 30; coverage < 20 reads; an alternate allele fraction < 10% and variant classification (Pathogenic variant (P); Variant, likely pathogenic (VLP); Variant of unknown significance (VUS)) 2.Positive Predictive Value (PPV) and Negative Predictive Value (NPV) ratio • PPV = TP / (TP + FP) Probability that a positive test indicates true disease (DCM) caused by other genes than MHY7 and TTN. • NPV = TN / (TN + FN) Probability that a negative test indicates absence of disease (DCM) caused by other genes. 3. Detection rate ratio of MYH7 and TTN versus other genes/variants associated with DCM with an analytical sensitivity and specificity >99%

—

Secondary

Measure	Time frame
There are no secondary objectives/outcomes for this study.	—

Countries

Belgium, Denmark, France, Hungary, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactChia-Ling Gau

Ambry Genetics Corporation

cgau@ambrygen.com+1 (949) 900-5500

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 16, 2026