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Tests treatment safety and results for Symptomatic Genetic Dilated Cardiomyopathy
Official title A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
ClinicalTrials.gov ID: NCT07210723
What this study is testing
What is danicamtiv?
danicamtiv is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for symptomatic genetic dilated cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM
- Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.
- Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core...
- Has a LVEF of ≤45%.
- Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to...
You likely can't join if
- Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined...
- Recent (\<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease...
- Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as...
- Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
- History of malignancy of any type within 5 years prior to Screening
- Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate [eGFR] \<15 mL/min/1.73m2 by simplified...
See the full eligibility criteria
- Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM
- Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.
- Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory.
- Has a LVEF of ≤45%.
- Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to the first visit.
- Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator.
- Can perform an upright cardiopulmonary exercise training (CPET) with a peak oxygen uptake (pV̇O2) of 80% or less of predicted for a healthy individual and respiratory exchange ratio (RER) of ≥1.05 Key
- Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator.
- Recent (\<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease (per Investigator), coronary revascularization (percutaneous coronary...
- Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled...
- Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
- History of malignancy of any type within 5 years prior to Screening
- Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate [eGFR] \<15 mL/min/1.73m2 by simplified Modification of Diet in Renal Disease equation [sMDRD]).
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation
- History of heart transplantation or anticipated heart transplantation in the next 6 months.
- Ongoing or anticipated advanced cardiac interventions, including chronic IV inotropic therapy, planned cardiac resynchronization therapy (CRT) or major surgery, or current/anticipated ventricular assist device placement...
- Clinically significant laboratory abnormalities at Screening
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.