Cats with Hypertrophic Cardiomyopathy: The HALT HCM Study
Principle Investigator
Description
This is a blinded, randomized, placebo-controlled clinical field study to provide substantial evidence of effectiveness of a disease modifying drug intervention in the management of ventricular hypertrophy in cats with subclinical Hypertrophic Cardiomyopathy (HCM). The study will consist of up to a 14-day screening period, followed by a 12-month once-weekly dosing period, with five post-enrollment study visits.
Testing Requirements
At your first visit to the clinic, your cat will undergo a thorough physical examination, blood and urine tests, electrocardiography, and diagnostic imaging (ultrasound and X-ray evaluations).
After the first (screening) visit, you will return to the clinic with your cat for follow-up evaluations 5 times over the course of the following year. You will also return to the clinic in the days following the screening visit to collect the first supply of study drug; however, your cat does not need to accompany you for this visit.
You must continue to dose your cat with the study medication, as well as any other medications deemed necessary by your Study Veterinarian, for the one-year course of the study. The study medication is given at home once weekly.
Enrollment Start
04/01/2025
Enrollment Finish
12/31/2026
Eligibility
Male, and surgically spayed female, cats with an echocardiography-confirmed diagnosis of subclinical HCM (i.e. that do not yet have outward symptoms of their heart disease) may be eligible if they meet these criteria:
Echocardiographic diagnosis of ACVIM Stage B1 or B2 HCM
• Body weight ≥2.5 kg (5.5 lb)
• Age ≥18 months and <15 years at enrollment
• Willing to take oral medications
• Elevation of cardiac biomarkers (NTproBNP) – to be confirmed by blood sample at the
HALT study clinical site
• Otherwise healthy; e.g. non-diabetic, no chronic infections
Exclusions
Cats with advanced or symptomatic HCM (ACVIM Stage C/D) at Screening or at any point in medical history
Sexually intact female
Cats unable to take and/or owners unable to administer oral medications
Any echocardiographic diagnosis that is not associated with HCM
Other significant systemic or congenital illness (e.g Diabetes Mellitus, IRIS stage 2 or greater CKD, hepatic disease, hyperthyroidism)
Active Infections
Non-Healed Wounds
Financial Incentive
All study related activities (physical exams, blood work, urinalysis, Echocardiography, ECGs, etc…) will be provided at no expense to you.
At the completion of the study and given all protocol related instructions are followed correctly, you will be compensated $500 for your time.
Additional Notes
Studies Led by NC State Associate Dean Propelling First Drug to Treat Feline Heart Condition to Market:
https://news.cvm.ncsu.edu/studies-led-by-nc-states-top-researcher-propelling-first-drug-to-treat-feline-heart-condition-to-market/
Flyer
Contact
Please email the Clinical Studies Core @ CVMclinicalstudies@ncsu.edu or call Briana Diquez at 919-515-3634
- Categories: