Health TrialsbyHealthPanel

A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

ConditionSymptomatic Genetic Dilated Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKardigan, Inc.

About this trial

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. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM.

The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood; this can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM).

The main goals of the study are:

* To assess the effect of danicamtiv on cardiac function using echocardiogram. * To evaluate the impact of danicamtiv on exercise capacity * To evaluate the safety and tolerability of danicamtiv

Participants will:

* Take danicamtiv or placebo every day for approximately 6 months * Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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 intervention [PCI] or coronary artery bypass graft [CABG]), or hospitalization for heart failure/intravenous (IV) diuretic use.

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 atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. > 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function.

Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).

Trial design

Design model

Parallel

Treatments tested in this trial

  • danicamtiv

    Drug

    Danicamtiv will be administrated twice daily for up to 26 weeks

  • Placebo

    Drug

    Placebo will be administrated twice daily for up to 26 weeks

Treatment groups

332 Participants
are divided into 2 treatment groups
Group A: danicamtivExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in Cohort 1

Time frame
26 weeks
2

Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in Cohort 1

Time frame
26 weeks

Secondary outcomes

1

Part 1: Change from Baseline (Day 1) to Week 26 in peak VO2

Time frame
26 weeks
2

Part 1: Association between response in left ventricular global longitudinal strain and/or left atrial function index after 2 weeks of active treatment with placebo-adjusted Week 26 response in peak VO2

Time frame
26 weeks
3

Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in overall population

Time frame
26 weeks
4

Part 1 and 2: Change from Baseline (Day 1) to Week 26 in left ventricular ejection fraction

Time frame
26 weeks

Other outcomes

1

Part 1 and 2: Incidence and severity of treatment emergent adverse events, adverse events of special interest, serious adverse events and disease related events

Time frame
26 weeks
2

Incidence of abnormal findings in laboratory assessments, physical examinations, 12-lead ECGs, and vital signs

Time frame
26 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kardigan, Inc.

Lead sponsor

Source ClinicalTrials.gov
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