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AN OPEN-LABEL, EXPLORATORY STUDY OF THE SAFETY AND PRELIMINARY EFFICACY OF DANICAMTIV IN STABLE AMBULATORY PARTICIPANTS WITH PRIMARY DILATED CARDIOMYOPATHY DUE TO EITHER MYH7 OR TTN VARIANTS OR OTHER CAUSALITIES

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505492-68-00
Acronym
CV028-005
Enrollment
21
Registered
2023-08-18
Start date
2020-10-06
Completion date
2024-01-23
Last updated
2024-02-05

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

Conditions

Primary Dilated Cardiomyopathy Due to Either MYH7 o TTN Variants

Brief summary

Clinical safety and tolerability as assessed by the following: • Frequency of treatment-emergent adverse events and serious adverse events in Part A • Frequency of clinically significant abnormalities from vital signs, adverse events, physical examination, ECG recordings, and safety labs in Part A

Detailed description

Change in the following PD parameters as assessed by TTE from Baseline corresponding to Parts A and B of the study: • Left ventricular SET • Parameters of left ventricular systolic function including but not limited to left ventricular stroke volume (LVSV), LVEF, left ventricular strain (LVGLS and LVGCS) and tissue doppler imaging (TDI) of mitral valve annulus peak systolic velocity (s') will be evaluated., Change in the following PD parameters as assessed by TTE from Baseline corresponding to Parts A and B of the study:• Parameters of left ventricular dimensions including left ventricular end-systolic and end-diastolic diameters (LVESD, LVEDD), left ventricular end-systolic and end-diastolic volumes indexed for body surface area (LVEDVI, and LVESVi)., Change in the following PD parameters as assessed by TTE from Baseline corresponding to Parts A and B of the study: • Parameters of left atrial volume and function including but not limited to minimum and maximum left atrium (LA) volumes indexed for body surface area (LAmaxVi, LAminVi), left atrial emptying fraction (LAEF), and left atrial function index (LAFI), Change in the following PD parameters as assessed by TTE from Baseline corresponding to Parts A and B of the study: • Parameters of left ventricular diastolic function including but not limited to TDI of mitral valve annulus peak velocity in diastole (e', lateral,septal), ratio of peak inflow velocities in early and late diastole (E/A), ratio of early mitral peak inflow velocity to early mitral peak annulus velocity (TDI) (E/e') lateral, septal, and average

Interventions

Sponsors

Myokardia Inc., Myokardia Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Clinical safety and tolerability as assessed by the following: • Frequency of treatment-emergent adverse events and serious adverse events in Part A • Frequency of clinically significant abnormalities from vital signs, adverse events, physical examination, ECG recordings, and safety labs in Part A

Secondary

MeasureTime frame
Change in the following PD parameters as assessed by TTE from Baseline corresponding to Parts A and B of the study: • Left ventricular SET • Parameters of left ventricular systolic function including but not limited to left ventricular stroke volume (LVSV), LVEF, left ventricular strain (LVGLS and LVGCS) and tissue doppler imaging (TDI) of mitral valve annulus peak systolic velocity (s') will be evaluated., Change in the following PD parameters as assessed by TTE from Baseline corresponding to Parts A and B of the study:• Parameters of left ventricular dimensions including left ventricular end-systolic and end-diastolic diameters (LVESD, LVEDD), left ventricular end-systolic and end-diastolic volumes indexed for body surface area (LVEDVI, and LVESVi)., Change in the following PD parameters as assessed by TTE from Baseline corresponding to Parts A and B of the study: • Parameters of left atrial volume and function including but not limited to minimum and maximum left atrium (LA) volumes

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026