TURN HEARTBREAK
INTO HOPE
A diagnosis of heart disease in your cat can be devastating
By participating in this international veterinary study, your cat can help researchers learn more about feline heart disease and potentially bring hope of a new treatment to future generations.
A diagnosis of heart disease in your cat can be devastating
By participating in this international veterinary study, your cat can help researchers learn more about feline heart disease and potentially bring hope of a new treatment to future generations.
ABOUT THIS STUDY
There’s hope for a longer, higher quality of life for feline patients with heart disease
This study is evaluating an investigational medication for the treatment of cats with heart disease.
Cats may qualify if they are:
- Diagnosed within the last 60 days
- Not diabetic and not on insulin
- At least 12 months of age
- Weigh at least 4.4 lbs (2 kg)
- Currently clinically stable (free of pleural effusion/pulmonary edema)
- Not pregnant, lactating, or intended for breeding
(See Veterinarians section for detailed Inclusion and Exclusion Criteria)
If your cat has already been screened and enrolled in the study, please complete this short post-enrollment form to ensure you receive your client credits.
Everything required by the study is free to cat owners1
This study provides up to 18 months of free care from a veterinary cardiologist. All patients will receive Standard of Care (also referred to as “best practice”), according to the American College of Veterinary Internal Medicine (ACVIM) guidelines.
Receiving diagnostic tests, medications, and veterinary exams according to ACVIM guidelines may reduce the likelihood of certain disease complications — including blood clots — and may slow progression of disease for all cats on study, including those on placebo.
Enrolled cats will receive ongoing monitoring and evaluations at no cost to owners, including:
- Cardiology exams
- All study-related diagnostics, including echocardiograms (ultrasounds of the heart) and electrocardiograms (heart rate and rhythm evaluations), and potentially chest x-rays
- Bloodwork
- Urinalysis
1For stable patients only, from screening forward. (Initial patient stabilization is not included in the study.)
ABOUT HEART DISEASE
Your cat is not alone
Heart disease is one of the most common diseases in cats
If you have been told your cat has heart disease, it can be very difficult news to understand and accept. But you may be surprised to know that the disease is common, affecting nearly 17% of cats (one in every six).
The main cause of feline heart disease is a thickening of the heart muscle. Sadly, there is no cure and no approved medication, so the disease reduces cats’ lifespans. Adding to the challenge, the clinical signs of heart disease are not obvious at first, which makes early diagnosis more difficult.
The signs of feline heart disease include:
- Poor general condition
- Weakness
- Lack of energy
- Weight loss
- Rapid or labored breathing
- British Shorthair
- Maine Coon
- Rag Doll
- Persian
- Chartreaux
- Sphynx
FIND A STUDY SITE
Hope may be in sight
Learn if there’s a study location near you
There are multiple veterinary cardiologists participating as investigators in this study.
Simply insert your zip code to search for one near you.
FAQs
IF YOU’D LIKE YOUR CAT TO PARTICIPATE IN THIS STUDY, BELOW ARE ANSWERS TO FREQUENTLY ASKED QUESTIONS (FAQs) THAT WILL HELP YOU GET STARTED
1. Who is conducting the study and where is it taking place?
The study sponsor is a veterinary pharmaceutical company. There are multiple veterinary hospitals participating as investigators in both the U.S. and Europe. All participating U.S. investigators are veterinary cardiologists. To learn whether there’s a study site near you, go to the ‘Find a Study Site’ section and simply insert your zip code into the search bar.
2. What is the dosage form of the investigational medication and who gives it to cats in the study?
The medication (or placebo) is a liquid, administered orally to cats by their owners once a day, at the same time each morning. Provided in an oral syringe, the liquid medication may be placed either directly in the cat’s mouth, or on a small amount of wet cat food.
3. I’m interested in signing up my cat. What should I do?
a. Find a study site. The first step is to ensure there’s a study site near you. Go to the ‘Find a Study Site’ tab and simply insert your zip code into the search bar.
b. Ask your veterinarian to complete the prescreening questionnaire. If there’s a study site in your area, then discuss the study with your veterinarian. If your cat has been diagnosed with heart disease in the last 60 days, and your veterinarian believes your cat is a good candidate, your veterinarian will complete the prescreening questionnaire here to start the process. After reviewing your cat’s information, the study investigator will determine if your cat is eligible for screening.
c. Take your cat to the cardiologist for screening. If your cat is determined to be eligible for screening, you will be contacted to schedule an appointment to bring your cat to the cardiology hospital to be screened. The screening process determines if your cat is eligible for enrollment.
4. If my cat is enrolled, what will I be required to do?
The staff at the veterinary cardiology hospital will walk you through all the requirements of the study. If your cat is screened and enrolled, you’ll be asked to:
- Administer the investigational medication to your cat once a day at the same time each morning
- Make note of when you give the medication
- Observe and report how your cat is doing
- Answer a few questions periodically about your cat’s quality of life
- Take your cat to the veterinary cardiologist as instructed for ongoing evaluations, approximately 6-7 times over the course of the study
It is requested that you not board your cat during the study if possible.
5. How long will the study last?
While each cat’s length of participation may vary slightly, most patients will participate up to 18 months. Continuation of therapy at the end of your cat’s participation in the study will be decided in consultation with your cat’s primary care veterinarian.
6. Is there a chance my cat will receive a placebo rather than the investigational medication?
Yes, 50% of enrolled cats will receive the investigational medication and 50% will receive the placebo (a liquid that looks identical, but has no medication in it).
Importantly, all cats in the study, including those patients receiving the placebo, will receive Standard of Care therapy for the disease (also known as ‘Best Medicine’), according to ACVIM guidelines. Standard of Care means that cats will be carefully monitored and may receive diuretics, blood thinners, and other medications to help treat or prevent disease complications.
Placebo-controlled, double-blinded studies such as this one are considered the gold standard in both human and veterinary studies, helping to ensure that the data collected are valid and unbiased.
The medication given to cats in the study may or may not help with their condition. As with all medications, there are risks and benefits – all of which will be discussed with you prior to enrolling your cat.
7. Are there any additional costs that I must pay with this study?
All required study activities will be paid by the study sponsor, including the screening visit at the participating veterinary cardiology hospital to determine if your cat qualifies for enrollment. Incidental costs, such as transportation to and from the cardiology hospital, will not be reimbursed by the study sponsor.
CONTACT
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VETERINARIANS
We hope you’ll refer your feline patients with CHF to this veterinary study
Congestive Heart Failure (CHF) has caused suffering in cats for too long. This study is seeking non-diabetic feline patients that have had their first CHF episode in the last 60 days and are currently stable.
We are conducting a double-blind, placebo-controlled study to evaluate an investigational medication with the goal of seeking regulatory approval from the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Everything required by the study is provided at no cost to owners of enrolled feline patients, including:
-
- Cardiac and respiratory exams
- Diagnostic tests, including echocardiogram (echo), electrocardiogram (ECG/EKG), thoracic radiography (x-ray), and systolic blood pressure (SBP)
- Bloodwork, including hematology, biochemistry, total thyroxin, fructosamine, NT-proBNP
- Urinalysis
Referring your patients is easy
If you believe you have feline patients that meet study inclusion and exclusion criteria outlined below, simply complete the prescreening questionnaire here to help us determine whether your patient is eligible for screening with the participating veterinary cardiologist in your area.
Study cardiologists will evaluate and review qualifications for each potential candidate and referring veterinarians will be informed of the decision.
INCLUSION AND EXCLUSION CRITERIA
INCLUSION CRITERIA
To be eligible, the following criteria must apply:
[1] Diagnosis at Screening Visit or history of primary HCM/HOCM:
- the size of the interventricular septum (IVSd) and/or the left ventricular free wall thickness in diastole (LVFWd) is ≥ 6 mm and
- LA/Ao ratio is ≥1.8
- HOCM cats are characterized by a systolic anterior motion (SAM) of the mitral valve coupled with diffuse left ventricular (LV) outflow tract turbulence
[2] Diagnosis of a first congestive heart failure episode (ACVIM Consensus Statement [7] Stage C) in the last 60 days as a result of a review of the radiographic or ultrasonographic imaging that was obtained at the time of CHF diagnosis with pulmonary edema or pleural effusion at the discretion of the Investigator
[3] Cat is clinically stable at enrollment (i.e., normal respiration (e.g., no effort to breathe, bright/alert/responsive, on oral medication, and under owner care)) at the Investigator’s discretion
[4] Signed Owner Informed Consent in accordance with Good Clinical Practice (GCP) and local legislation
[5] Age: ≥ 12 months at Screening Visit
[6] Body weight ≥ 4.4 lbs/2.0 kg at Screening Visit
EXCLUSION CRITERIA
The cat is not eligible if one or more of the following criteria applies:
[1] Current or past treatment with a SGLT2 inhibitor (e.g., velagliflozin, bexagliflozin)
[2] Treatment with furosemide doses ≥10 mg/kg per day or torasemide doses ≥0.6mg/kg per day at Screening Visit
[3] Diagnosis of diabetes mellitus in the past or at Screening Visit (e.g., serum fructosamine above reference range of central laboratory, detection of glucosuria) or under treatment with any anti-diabetic drugs
[4] Current treatment with any drugs listed under “Prohibited concomitant treatment”
[5] Heart diseases other than primary hypertrophic cardiomyopathy (e.g., congenital heart diseases, other cardiomyopathies, taurine deficiency, or potential neoplastic diseases such as cardiac lymphoma, etc.)
[6] Arrhythmias that require medical therapy at the discretion of the Investigator (e.g., atrial fibrillation, 3rd-degree atrioventricular (AV) Block)
[7] History or presenting with clinical signs of feline arterial thromboembolism (FATE) at Screening Visit
[8] Detection of intracardiac thrombi via echocardiography at Screening Visit
[9] Hyperthyroidism (i.e., total thyroxine (TT4) level above reference range of central laboratory) or cats currently receiving medication or dietary treatment for hyperthyroidism at Screening Visit
[10] Systemic arterial hypertension (systolic blood pressure ≥ 160 mmHg) at Screening Visit
[11] Severe dehydration (e.g., considerable loss of skin turgor, enophthalmos, dry mucous membranes, weak/thready pulses, systemic hypotension, or altered level of consciousness) at Screening Visit
[12] Moderate to severe renal failure (blood creatinine value ≥ 251 µmol/L or ≥ 2.9 mg/dL) at Screening Visit and known primary renal dysfunction in the judgment of the Investigator
[13] Concurrent chronic lower respiratory diseases (e.g., feline asthma) at Screening Visit
[14] Persistent diarrhea (duration > 7 days) in the last 14 days before Screening Visit
[15] Other concomitant disease/condition (e.g., acromegaly, cachexia, neoplasia, systemic infection, anemia, or known heart worm infection/disease) that might interfere with the study results
[16] Pregnant, lactating, or intended for breeding
[17] Ongoing participation in another study or previously enrolled in this study
CONCOMITANT TREATMENTS
PROHIBITED CONCOMITANT TREATMENTS
Medications listed in the table below under Prohibited Concomitant Treatments, are not allowed between the diagnosis of first congestive heart failure episode and Screening Visit and will lead to post-inclusion removal if given after inclusion in the study.
PROHIBITED CONCOMITANT TREATMENTS |
|
Any SGLT-2 inhibitors
|
| Antidiabetics (e.g., insulin) and any other blood glucose-lowering medication |
ALLOWED CONCOMITANT TREATMENTS
Medications listed below in Allowed Concomitant Treatments – Extended Use Phase, supplements and homeopathic remedies intended to treat heart disease are not allowed 30 days prior to screening. Similarly, these medications are also not allowed after study inclusion, unless a cat experiences a cardiac morbidity event and requires administration of another cardiovascular drug (in addition to the cat’s standard medication at this time), concomitant treatment with the medication listed in the table below is allowed. Cats automatically enter the extended-use phase of the study after their first cardiac morbidity event since inclusion.
ALLOWED CONCOMITANT TREATMENTS
|
| Drugs for obstructive airways diseases (e.g., albuterol, salbutamol) |
| Corticosteroids for systemic use (e.g., prednisolone) to treat the heart disease |
| Digitalis glycosides (e.g., digoxin) |
| Calcium-channel blockers (e.g., amlodipine, diltiazem, verapamil) |
| Corticosteroids for systemic use (e.g., prednisolone) to treat the heart disease |
| Digitalis glycosides (e.g., digoxin) |
| Calcium-channel blockers (e.g., amlodipine, diltiazem, verapamil) |
| Other antiarrhythmic drugs |
|
ß-receptor blocker (e.g., atenolol, bisoprolol, carvedilol, esmolol, metoprolol, nadolol, propranolol)
|
|
Potassium-sparing diuretics, spironolactone
|
| Low-ceiling diuretics, thiazides |
|
Nitroglycerine
|
| Pimobendan |
| Angiotensin Receptor Blockers/ARBs (e.g., losartan, eprosartan, valsartan, irbesartan, tasosartan, candesartan, telmisartan, olmesartan medoxomil, azilsartan medoxomil, fimasartan) |
Treatments that have no impact on the condition being investigated (e.g., antibiotic therapy, potassium supplementation, food supplements, vaccines, anthelmintic drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and homeopathic products) and that are not listed as prohibited treatment may be administered.
ALLOWED CONCOMITANT TREATMENTS |
| Clopidogrel |
| Acetylsalicylic acid |
| Rivaroxaban |
| Apixaban |
| Furosemide (maximum dosage 10 mg/kg BW per day) |
| Torasemide (maximum dosage 0.6 mg/kg BW per day) |
| ACEIs (e.g. enalapril, benazepril, captopril, fosinopril, imidapril, lisinopril, ramipril) |
|
Gabapentinoids (e.g., gabapentin, pregabalin) for alleviating anxiety associated with transportation and the clinic visits.
|
The medication given to cats in the study may or may not help with their condition. As with all medications, there are risks and benefits — all of which will be discussed with owners prior to enrolling their cats.