Purpose of this Study
This study has two parts. The first part includes about eighty people, and the second part includes about two hundred fifty people. Each part of the study lasts about thirty six weeks. The study begins with screening to see if someone can join. Then there is a short period where everyone first takes a placebo and then a short period where everyone takes the study medicine. After that, people are placed by chance into groups to take either the study medicine or a placebo for about twenty four weeks. At the end, there is a follow up period where doctors check safety. Each person will join only one part of the study.
Who Can Participate?
Eligibility
People can join this study if they are 18 years or older and have a heart disease called dilated cardiomyopathy that runs in their family or is caused by certain genetic changes. This condition makes the heart weak and enlarged. Their heart must pump less strongly than normal, with an ejection fraction of 45 percent or lower. They must be taking standard heart failure medicines at steady doses and have been feeling stable for at least one month. Their heart condition must not be caused by things like heavy alcohol use, certain cancer treatments, pregnancy related heart problems, infections, or other temporary conditions. The heart rhythm must allow doctors to do heart scans. Participants must also be able to complete an exercise test that shows their heart function is reduced compared to healthy people.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The goal of this study is to see if a medicine called danicamtiv is safe and works better than a placebo for people who have a type of heart disease called genetic or familial dilated cardiomyopathy. The medicine will be taken twice each day. The study will check how the body handles the medicine, how safe it is, and if it helps improve heart health.
The study has two main parts and two groups in each part. About eighty people will take part in the first part, and about two hundred fifty people will take part in the second part. Each person will be placed into one group, and the same group assignments will be used in both parts of the study.
Locations
Other
Visit Timing
Weekdays
Evenings
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy
Principal Investigator
Ravi
Karra
Protocol Number
PRO00118808
NCT ID
NCT07210723
Phase
II/III
Enrollment Status
Pending Open to Enrollment