Title: Evaluation of efficacy and safety of an investigational oral drug vs. placebo on progression-free survival time in cats with primary cardiomyopathy and congestive heart failure
Investigator:
Amanda Coleman, DVM, DACVIM (Cardiology)
If interested, please have your primary veterinarian request additional information from our Clinical Trials office at 706-296-7818. Veterinarians may also visit FelineHeartStudy.com and complete the prescreening questionnaire to help determine if a patient is eligible for screening.
Study description:
This multi-center pivotal study is a double-blind, placebo-controlled clinical trial evaluating a once daily, oral medication for safety and effectiveness in treating cats with heart failure. The primary study objective is to determine whether study drug, compared to placebo, prolongs time to cardiac mortality or morbidity in cats with primary cardiomyopathy and congestive heart failure.
Inclusion criteria:
- Cats having first congestive heart failure episode within the last 60 days
- Cats at least 12 months of age and weighing at least 2.0 kg
- Currently clinically stable (free from pleural effusion/pleural edema)
Exclusion criteria:
- Current or past treatment with a SGLT-2 inhibitor
- Diagnosis of diabetes mellitus or under treatment with any anti-diabetic drug
- Treatment with furosemide doses > 10 mg/kg or torsemide > 0.6 mg/kg per day at screening
- Heart diseases other than primary cardiomyopathy
- Arrhythmias requiring medical therapy (atrial fibrillation, 3rd degree AV block, ventricular ectopy
- History of, or presenting with feline arterial thromboembolism at screening
- Detection of intracardiac thrombi via echocardiography at screening
- Systemic arterial hypertension at screening
- Severe dehydration at screening
- Hyperthyroidism or currently receiving treatment for hyperthyroidism at screening
- Other concomitant disease or condition that may interfere with study outcomes (i.e. moderate kidney disease, chronic lower respiratory disease, neoplasia, anemia, heartworm disease)
- Current or past treatment with prohibited medications (angiotensin II receptor blockers, digitalis glycosides, Ca-channel blockers, antiarrhythmic drugs, potassium-sparing diuretics, spironolactone, thiazides, nitroglycerine, long lasting corticosteroids, drugs treating obstructive airway diseases, pimobendan, β-receptor blockers)
Cats with a history of primary cardiomyopathy and who have experienced their first episode of congestive heart failure within 60 days of screening and are clinically stable may be eligible for the study. Cats meeting all eligibility criteria will be randomized to once daily treatment with either the study drug or placebo, along with standard of care treatments, and re-evaluated during regular in-clinic visits (day 30, 90, 180 and every 6 months thereafter) and by phone (day 10, 120, 270 and every 6 months thereafter), until the end of the study, or withdrawal/removal due to patient health.
For each cat, the initial visit will include a history; physical examination; blood collection for CBC, chemistry profile, and measurement of serum cardiac biomarkers, total thyroxine and fructosamine; urinalysis; blood pressure measurement; and echocardiogram with ECG. Thoracic radiographs will also be performed if the cat’s condition allows. At each in-hospital recheck, the same tests (except TT4 and fructosamine measurement, urinalysis and ECG) will be performed. Urinalysis will be performed at the day 90 and end-of-study rechecks, and thoracic radiography will be performed at the investigator’s discretion. Owners will be asked to record daily administration of study drug and to complete a weekly quality of life survey for the first 3 months of the study, then monthly thereafter until study end.
The trial is fully funded and covers the cost of all visits, exams, diagnostics, and labwork required by the study.
Duration of study:
The study is currently OPEN.
Potential benefits to veterinary medicine:
This study may have potential beneficial cardiac effects for cats with congestive heart failure, thus helping to advance the standard of medicine in both pets and people.
