IMB-1018972 for Cardiomyopathy, Hypertrophic

Phase-Based Estimates
1
Effectiveness
2
Safety
Imbria Investigational Site, Charlotte, NC
Cardiomyopathy, Hypertrophic+3 More
IMB-1018972 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cardiomyopathy, Hypertrophic

Study Summary

This study is evaluating whether a drug may help treat a type of heart disease.

See full description

Eligible Conditions

  • Cardiomyopathy, Hypertrophic
  • Cardiomyopathies
  • Hypertrophy
  • Non-obstructive Hypertrophic Cardiomyopathy

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether IMB-1018972 will improve 1 primary outcome and 1 secondary outcome in patients with Cardiomyopathy, Hypertrophic. Measurement will happen over the course of Baseline, Week 12.

Week 14
Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
Baseline, Week 12
Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo
IMB-1018972 200mg
Placebo group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. IMB-1018972 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

IMB-1018972 200mg
Drug
Placebo
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through week 14 safety follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline through week 14 safety follow-up for reporting.

Closest Location

Imbria Investigational Site - Charlotte, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of Hypertrophic Cardiomyopathy consistent with current US and European guidelines
Ability to perform an upright treadmill cardiopulmonary exercise test
Agreement to abide by contraceptive requirements

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can cardiomyopathy, hypertrophic be cured?

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Cardiomyopathy may be a form of 'neurogenic cardiomyopathy' related to a primary neurogenic condition. The neurogenic condition is a chronic condition that may be cured. Therefore, hypertrophic cardiomyopathy may also be related to a degenerative neurogenic condition and hence may be curable.

Unverified Answer

How many people get cardiomyopathy, hypertrophic a year in the United States?

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Recent findings emphasize the rarity of cardiomyopathy, hypertrophic cardiomyopathy, or restrictive cardiomyopathy and suggest that, in the current referral processes for testing of individuals with suspected heart disease, these diagnoses are not routinely screened for in clinical practice and thus underrecognized.

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What causes cardiomyopathy, hypertrophic?

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There are numerous causes of cardiomyopathy, particularly hypertrophic cardiomyopathy. Cardiac arrhythmias in hypertrophic cardiomyopathy may result in cardiomyopathy. Exercise may unmask latent myoobliteration, leading to cardiomegaly and cardiac dysfunction. The most common cause of arrhythmias is coronary artery disease. In some cases, hypertrophic cardiomyopathy may result from mutation in troponin T. Cardiomyopathy may be part of a wider endocrine disease state, such as Graves' disease, in which the primary manifestation is cardiomegaly.

Unverified Answer

What are common treatments for cardiomyopathy, hypertrophic?

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Despite the many different diagnoses for cardiomyopathy, no medications have been shown to have strong evidence for their efficacy or safety in treating cardiomyopathies. The use of steroids, digoxin, beta-blockers, and statins does not seem to be useful in treating cardiomyopathy, and they have not been proven safe in this setting. Exercise as the primary therapy for cardiomyopathy may be beneficial when coupled with counseling. Cardiomyopathy may be a chronic disease that worsens over time and can lead to more serious diseases and a shortened lifespan.

Unverified Answer

What are the signs of cardiomyopathy, hypertrophic?

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The most common cardiac signs in patients with hypertrophic cardiomyopathy are tiredness, shortness of breath, chest pain, palpitation, or syncope. In patients with HCM, cardiac tamponade is a rare but serious complication. The presence of clinical signs and ECGs should alert the physician to perform an echocardiogram to make the timely diagnosis of HCM.

Unverified Answer

What is cardiomyopathy, hypertrophic?

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Cardiomyopathy, hypertrophic occurs in many breeds and affects males and females equally. The onset of cardiomyopathy, hypertrophic is usually related to age, but can occur from one week to the life of a purebred dog. It can have many signs, including fast, weak heart rate, breathing fast, and/or coughing. Ventricular hypertrophy and cardiomyopathy are the two main causes of death in young dogs.

Unverified Answer

Who should consider clinical trials for cardiomyopathy, hypertrophic?

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Clinical trials targeted specifically for patients with hypertrophic cardiomyopathy and/or heart failure are still being proposed. Some considerations for and against clinical trials include disease severity, comorbidities, availability of specific treatments, risks of adverse events, safety and cost.

Unverified Answer

Is imb-1018972 safe for people?

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In this pilot trial, no clinical serious adverse event were observed at either dose. The study suggests more frequent clinical laboratory monitoring is safe in patients enrolled in the trial.

Unverified Answer

What is the average age someone gets cardiomyopathy, hypertrophic?

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Cardiomyopathy, hypertrophic is an early-onset disease that can affect someone of all ages. As the disease becomes more progressive, it eventually occurs in all ages; however, it occurs more frequently in younger individuals.

Unverified Answer

Is imb-1018972 typically used in combination with any other treatments?

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While the data suggests that a combination dose of 5, 6, and 7.5 mg of IMP-1018972 combined with a PXR agonist or CYP17A1 inhibitors may significantly improve the response to IMP-1018972 compared to the administration of this drug alone, further clinical trials are needed to fully address these potential effects. The data also suggests that this combination may be an attractive option for patients who would potentially receive only one treatment with IMP-1018972 and have significant cardioprotection.

Unverified Answer

What is the primary cause of cardiomyopathy, hypertrophic?

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The most common cause of cardiomyopathy in patients with no history of cardiac disease and no abnormal ECG is hypertrophic cardiomyopathy, with roughly 4 cases per 1000 to 1000 cases of coronary artery disease.

Unverified Answer
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