July 30th, 2025

Objective:

Congestive Heart Failure (CHF) has caused suffering in cats for too long. This study is seeking non-diabetic feline patients who have had their first CHF episode in the last 60 days and are currently stable. This clinical trial is 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).

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

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 thyroxine, fructosamine, NT-proBNP

• Urinalysis

Inclusion Criteria:

To be eligible, the following criteria must apply:

[1]a. 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

• HOCM cats are characterized by a systolic anterior motion (SAM) of the mitral valve coupled with diffuse left ventricular (LV) outflow tract turbulence

b. other phenotypes of primary cardiomyopathy: diagnosed based on criteria of ACVIM consensus statement.

[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

Non-inclusion 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 cardiomyopathy (e.g., congenital heart diseases, 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

Learn more by visiting: www.felineheartstudy.com

JUN 04, 2019

*NOTE: This study is not currently enrolling new patients until further notice*

The primary aim of the study is to assess the clinical responses of cats with naturally occurring mild to moderate chronic enteropathy when fed different types of dry kibble diets. As part of this study, three visits to Red Bank Veterinary Hospital in Tinton Falls are required for the patient. Owners must be willing to weigh the cat’s food daily for the entire 12 weeks. The owner will be required to fill out some screening paper work before making the appointment, as well as, complete a daily log of their cat’s habits for the duration of the study. The majority of the study is at no cost to the client.

INCLUSION:

• Cat must be 1-8 years old

• Indoor only

• Body Condition Score (BCS) 3-7/9

• Must have recurring vomiting and/or small bowel diarrhea for > 3 weeks

• Willing and able to eat 100% dry food with no wet food, “toppers”, or treats

• No evidence of systemic illness

• If found to be hypocobalaminemic (low in vitamin B12), the owner must be willing to follow the Texas A&M parenteral supplementation protocol, involving weekly and monthly injections.

• If a multicat household (up to 3 cats total), the owner must be able to feed all cats in the house the test diet. The owner must also be able to submit patient log information based on only the cat participating in the study.

• All cats in the household must be dewormed with Panacur (fenbendazole) for 5 days within 1 month prior to study enrollment.

• Cats that have undergone previous, but unsuccessful, medical treatment for gastrointestinal signs are still eligible.

NON-INCLUSION:

• History of constipation, tenesmus, hematochezia

• Vomiting exclusively hairballs

• Use of oral immunosuppressives within prior 3 weeks

• Use of long acting immunosuppressives within prior 6 weeks

• Use of antibiotics (e.g., tylosan, metronidazole) within prior 4 weeks

• Use of probiotics within prior 4 weeks

• History of > 10% unintentional weight loss within prior 2 months.

OWNER INCENTIVES:

• Initial Visit: Patient will receive a complimentary physical exam, complete blood count, chemistry with electrolytes, urinalysis, thyroxine level (T4), feline leukemia virus (FeLV), feline immunodeficiency virus (FIV), heartworm antigen and antibody, gastrointestinal (GI) panel, fecal test, abdominal x-rays and ultrasound at the initial visit. Some of these tests will not be repeated if they have been completed in the prior 4 weeks, nor will the owner be reimbursed.

• 4-week and 12 week rechecks: Patient will receive complimentary physical exams and recheck labwork.

• Food will be provided at no cost for all cats in the home, regardless of participation in the study.

COST TO CLIENT:

If the cat is hypocobalaminemic, cobalamin supplementation must be undertaken at the client’s own expense. Administration of Panacur prior to study enrollment is also at the client’s own expense.

CONTACT:

Sabrina Appell, Administrative Assistant 197 Hance Avenue, Tinton Falls Clinical Nutrition Department (732) 747-3636

Martha Cline, DVM DACVN 197 Hance Avenue, Tinton Falls Clinical Nutrition Department (732) 747-3636

JUN 04, 2019

Pulmonic stenosis is a birth defect in the heart. It is caused by an incomplete pulmonary valve on the right side of the heart. It can result in serious, life-threatening changes in the way that the heart pumps blood. This study will aim to collect data on procedural technique of the corrective surgery.

OWNER INCENTIVES

Discounted charges for the procedure are the incentive. A free initial screening echocardiogram is included with the first visit. The client is responsible for all other charges including the initial standard exam fee. The procedure will be discounted and capped at $3,500.00.

CONTACT

Kristine Brown, DVM, Resident in Cardiology Holly M. Sawyer, DVM, Resident in Cardiology RBVH Cardiology Department (Tinton Falls) (732) 747-3636

JUN 04, 2019

Patent ductus arteriosus (also called PDA) is a birth defect in the heart. It is caused by incomplete changes in the heart’s circulation when a dog or cat is born. This results in serious, life-threatening changes in heart function and size. This study will aim to collect data on procedural technique of the corrective surgery.

OWNER INCENTIVES

Discounted charges for the procedure are the incentive. A free initial screening echocardiogram is included with the first visit. The client is responsible for all other charges including the initial standard exam fee. The procedure is normally $7,000 but will be discounted and capped at $4,000.

CONTACT

Kristine Brown, DVM, Resident in Cardiology Holly M. Sawyer, DVM, Resident in Cardiology RBVH Cardiology Department (Tinton Falls) (732) 747-3636

JUN 04, 2019

PURPOSE

To evaluate the relevance of history and presentation in the evaluation of chronic valve disease in small breed dogs.

CASE SELECTION

All dogs <20kg and older than 8 years with a significant systolic heart murmur. Study will cover a free echocardiogram.

EXCLUSION CRITERIA

• Dogs with other clinically relevant cardiac diseases (minor tricuspid valve disease will be included).

• Dogs receiving antitussive medications (including corticosteroids, bronchodilators, cough suppressants).

• Dogs receiving cardiac medications (pimobendan, enalapril, spironolactone).

OWNER INCENTIVES

Clients will be responsible for some of the evaluation, but will be given a substantial discount.The following is provided by the Study at NO CHARGE to clients:

• Echocardiogram

• ECG

(A value of $794.33)

CLIENT RESPONSIBILITIES

Client is responsible for all other charges including, but not limited to:

• Exam fee

• Thoracic radiography (will not be repeated if adequate films already acquired)

FOR MORE INFORMATION

Katie Pesce, VMD Cardiology Department Phone: (732) 747-3636