IMPROVE-HCM
Research type
Research Study
Full title
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients with Non-obstructive Hypertrophic Cardiomyopathy
IRAS ID
294345
Contact name
Karen Jauregui
Contact email
Sponsor organisation
Imbria Pharmaceuticals, Inc.
Eudract number
2020-005387-63
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 0 days
Research summary
Hypertrophic cardiomyopathy (HCM) is most often caused by abnormal genes in the heart muscle. These genes cause the walls of the heart chamber (left ventricle) to contract harder and become thicker than normal. The thickened walls become stiff. This reduces the amount of blood taken in and pumped out to the body with each heartbeat. In non-obstructive HCM, the heart’s main pumping chamber becomes stiff. This limits how much blood the ventricle can take in and pump out, but blood flow is not blocked.
In this study, the Sponsor, Imbria Pharmaceuticals Inc., plans to evaluate the safety and tolerability of a novel drug IMB-1018972, in patients with non-obstructive HCM, in addition to a preliminary evaluation of the ability of IMB-1018972 to improve cardiac energetics and peak VO2.
Patients completing the study will be enrolled for a period of approximately 18 weeks (4-week screening period; 12-week double-blinded, parallel-group, placebo-controlled treatment period; and a 2-week safety follow-up period).
Patients randomized in the UK will, if eligible, be automatically randomized into a Cardiovascular Magnetic Resonance (CMR) sub-study and undergo evaluation of cardiac structure, function and energetics.
A total of approximately 70 men and women, aged 18 through 75 years, will be enrolled into the study and randomly assigned equally across 2 groups to receive IMB-1018972 200 mg MR tablets orally BID or matching placebo for a minimum of 12 weeks, with up to 4 additional weeks of dosing to provide flexibility to clinical sites during COVID-19.
This study will be conducted in only one site in the United Kingdom.
REC name
HSC REC A
REC reference
21/NI/0041
Date of REC Opinion
16 Mar 2021
REC opinion
Further Information Favourable Opinion