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Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities

Primary Purpose

Primary Familial Dilated Cardiomyopathy

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
danicamtiv
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Familial Dilated Cardiomyopathy focused on measuring Primary dilated cardiomyopathy (DCM), Familial dilated cardiomyopathy (DCM), Myosin Heavy Chain 7 (MYH7), Titin (TTN), MYK-491, danicamtiv

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has stable primary dilated cardiomyopathy due to either MYH7 or TTN variant
  • Has adequate acoustic windows for echocardiography
  • Maximum of 3 family members with same variant can be enrolled

Exclusion Criteria:

  • Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s)
  • A pathogenic variant implicated in DCM of another gene other than MYH7 or TTN
  • Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics)
  • Presence of protocol specified laboratory abnormalities at Screening
  • Recent acute coronary syndrome or angina pectoris (<90 days)
  • Recent hospitalization for heart failure (<90 days)

Sites / Locations

  • University Of California - San Diego Medical CenterRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • University of South FloridaRecruiting
  • Northwestern Medical Faculty FoundationRecruiting
  • Brigham And Women'S HospitalRecruiting
  • Mayo Clinic - RochesterRecruiting
  • Cleveland ClinicRecruiting
  • Ohio State University Medical CenterRecruiting
  • University of PennsylvaniaRecruiting
  • Medical University of South CarolinaRecruiting
  • Local Institution - 0008
  • St. David's Heart & Vascular PLLC, dba Austin HeartRecruiting
  • Local InstitutionRecruiting
  • Universitaetsklinikum Wuerzburg-Department of DermatologyRecruiting
  • Local Institution - 0012Recruiting
  • Local InstitutionRecruiting
  • Local InstitutionRecruiting
  • Local InstitutionRecruiting
  • Local InstitutionRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MYK-491

Arm Description

Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants

Outcomes

Primary Outcome Measures

Frequency and severity of treatment-emergent adverse events and serious adverse events.
Number of participants with vital sign abnormalities
Number of participants with adverse event abnormalities
Number of participants with physical examination abnormalities
Number of participants with ECG abnormalities
Number of participants with safety lab abnormalities

Secondary Outcome Measures

Change in pharmacodynamic (PD) parameters assessed by transthoracic echocardiography (TTE)
Parameters include: Left ventricular systolic ejection time Left ventricular stroke volume Left ventricular ejection fraction Left ventricular global longitudinal strain Left ventricular global circumferential strain Tissue Doppler imaging (TDI) of mitral valve annulus peak systolic velocity (s') Left ventricular end systolic diameter Left ventricular end diastolic diameter Left ventricular end diastolic volume, indexed for body surface area (BSA) Left ventricular end systolic volume, indexed for BSA Left atrial maximum volume, indexed for BSA Left atrial minimum volume, indexed for BSA Left atrial emptying fraction Left atrial function index TDI of mitral valve annulus peak velocity in diastole (e', lateral, septal) Ratio of peak inflow velocities in early and late diastole Ratio of early mitral peak inflow velocity to early mitral peak annulus velocity (TDI) (E/e') lateral, septal, and average

Full Information

First Posted
September 9, 2020
Last Updated
August 31, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04572893
Brief Title
Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
November 24, 2023 (Anticipated)
Study Completion Date
January 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Familial Dilated Cardiomyopathy
Keywords
Primary dilated cardiomyopathy (DCM), Familial dilated cardiomyopathy (DCM), Myosin Heavy Chain 7 (MYH7), Titin (TTN), MYK-491, danicamtiv

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MYK-491
Arm Type
Experimental
Arm Description
Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants
Intervention Type
Drug
Intervention Name(s)
danicamtiv
Other Intervention Name(s)
MYK-491, BMS-986434
Intervention Description
Myosin activator
Primary Outcome Measure Information:
Title
Frequency and severity of treatment-emergent adverse events and serious adverse events.
Time Frame
Up to 22 days, optional extension of up to 96 weeks
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 22 days, optional extension of up to 96 weeks
Title
Number of participants with adverse event abnormalities
Time Frame
Up to 22 days, optional extension of up to 96 weeks
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 22 days, optional extension of up to 96 weeks
Title
Number of participants with ECG abnormalities
Time Frame
Up to 22 days, optional extension of up to 96 weeks
Title
Number of participants with safety lab abnormalities
Time Frame
Up to 22 days, optional extension of up to 96 weeks
Secondary Outcome Measure Information:
Title
Change in pharmacodynamic (PD) parameters assessed by transthoracic echocardiography (TTE)
Description
Parameters include: Left ventricular systolic ejection time Left ventricular stroke volume Left ventricular ejection fraction Left ventricular global longitudinal strain Left ventricular global circumferential strain Tissue Doppler imaging (TDI) of mitral valve annulus peak systolic velocity (s') Left ventricular end systolic diameter Left ventricular end diastolic diameter Left ventricular end diastolic volume, indexed for body surface area (BSA) Left ventricular end systolic volume, indexed for BSA Left atrial maximum volume, indexed for BSA Left atrial minimum volume, indexed for BSA Left atrial emptying fraction Left atrial function index TDI of mitral valve annulus peak velocity in diastole (e', lateral, septal) Ratio of peak inflow velocities in early and late diastole Ratio of early mitral peak inflow velocity to early mitral peak annulus velocity (TDI) (E/e') lateral, septal, and average
Time Frame
Up to 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN Has adequate acoustic windows for echocardiography Maximum of 3 family members with same variant can be enrolled For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants Exclusion Criteria: Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s) Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics) Presence of protocol specified laboratory abnormalities at Screening Recent acute coronary syndrome or angina pectoris (<90 days) Recent hospitalization for heart failure (<90 days)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center http://www.bmsstudyconnect.com
Phone
855-907-3286
Email
clinical.trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of California - San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Adler, Site 0007
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hofmeyer, Site 0010
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Mcdonald, Site 0009
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-5966
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Wilcox, Site 0002
Facility Name
Brigham And Women'S Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Lakdawala, Site 0003
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveen Pereira, Site 0005
Phone
843-876-0111
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilson Tang, Site 0006
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond E. Hershberger, Site 0019
Phone
614-688-1305
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anjali Owens, Site 0001
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Judge, Site 0004
Facility Name
Local Institution - 0008
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Completed
Facility Name
St. David's Heart & Vascular PLLC, dba Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Ginns, Site 0018
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Universitaetsklinikum Wuerzburg-Department of Dermatology
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0012
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution
City
Middlesex
ZIP/Postal Code
UB9 6JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities

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