Your referrals are vital to this important clinical study.
Wait! Before you prescribe…
Many medications such as ACE inhibitors are prohibited during the study (see the full list on this page), and may eliminate a dog from qualifying, or delay enrollment in the study. So you’ll want to refrain from prescribing excluded medications to your canine patients whose owners are interested in study participation. All dogs in the study receive the test medication, so there is no chance your enrolled patient will go untreated.
We are currently enrolling dogs diagnosed with ACVIM Stage B2 MMVD to evaluate an investigational medication to determine whether it may delay the onset of CHF.
This is an FDA-regulated study with benefits for you, your patient, and your client.
How do I refer a patient?
1. Referral
Call the study site in your area. Tell them you would like to refer a patient to the “Dog Heart Study,” and they will walk you through the referral process.
2. Screening
Once the referral process is complete, have your client call the Study Site to schedule a screening appointment.
If the dog is enrolled in the study, you complete and send in the W-9 and Payment Acknowledgement Forms and your client completes the Owner Form.
OWNER FORM
If you would like your client credit available at the location where you participated in the EPOCHAL Cardiology Study, you do NOT need to complete this form.
If you prefer to have your client credit sent to your dog’s regular veterinarian, please proceed and be sure to input your primary care veterinarian’s information.
Eligible canine patients you refer remain in your regular care while receiving a full year of specialty care overseen by veterinary cardiologists.
All study participants receive the investigational medication, not a placebo. The investigational medication is now in the final stage of testing before submission to the FDA.
You can be confident your patients will receive quality care and benefits, including up to a $500 credit to spend at your clinic once your patient’s participation is complete.
In order to ensure you receive payment of client credits at your hospital, please complete and forward an Acknowledgement Form and W-9 Tax Form to us and ensure each participating dog owner completes this short form.
Inclusion and exclusion criteria are listed in the charts below, as well as prohibited and permitted concomitant medications. We also welcome your questions at any time.
Inclusion criteria
- A moderate to high intensity systolic heart murmur with maximal intensity over the mitral area (≥ grade 3/6).
- Echocardiographic evidence of MMVD defined as characteristic valvular lesions of the mitral valve apparatus (leaflet thickening, valve prolapse, ruptured chordae tendinae).
- Presence of mitral regurgitation on the color Doppler echocardiogram.
- Echocardiographic evidence of left atrial dilatation, i.e. 2D left atrial/aortic (LA/Ao) ratio ≥ 1.8 by the Swedish method.
- Radiographic evidence of cardiomegaly (vertebral heart size [VHS] score > 10.5).
- Dogs must be at least 6 years of age.
- Dogs must have a body weight between 4.1 kg and 15 kg (9 lb and 33.1 lb).
Exclusion criteria
- Current or previous evidence of cardiogenic pulmonary edema.
- Clinically significant supraventricular and/or ventricular tachyarrhythmia (i.e. requiring antiarrhythmic therapy).
- Current or previous evidence of clinically significant coughing that interferes with the clinical assessment of progressing clinical signs.
- Current or previous evidence of syncope.
- Cardiac disease other than MMVD disease (excluding concurrent tricuspid insufficiency where disease of the mitral valve is considered to be the more significant abnormality).
- Known significant systemic or other organ-related disease that will limit the dog’s life expectancy or requires chronic treatment (See prohibited medications below.) Dogs with hypothyroidism may be included provided the Investigator deems them clinically stable on pharmacotherapy.
- Evidence of clinically relevant pulmonary hypertension (right atrial: right ventricular [RA:RV]) gradient > 65 mmHg).
- Pretreatment for cardiovascular disease with any agent on the prohibited medication list below.
- Pregnant or lactating.
Prohibited concomitant medications*
*All commercially available topical treatments for ears and eyes are allowed even if some ingredients are found in the table below.
| Type | Examples |
| ACE-Inhibitors | enalapril, benazepril, captopril, fosinopril, imidapril, lisinopril, ramipril |
| Angiotensin II receptor blockers | candesartan, telmisartan |
| Antiarrhythmics | lidocaine, bretylium, flecainide, mexiletine, procainamide, phenytoin, propafenone, quinidine, tocainide, beta-blockers, [atenolol, bisoprolol, carvedilol, esmolol, metoprolol, nadolol, propranolol], amiodarone, sotalol, Ca++ channel blockers [diltiazem, verapamil], digoxin, digitoxin |
| Anticholinergics | atropine, glycopyrrolate, propantheline |
| Beta-blockers | atenolol, bisoprolol, carvedilol, esmolol, metoprolol, nadolol, propranolol |
| Diuretics | furosemide, hydrochlorothiazide, thiazides, chlorothiazide, torasemide, spironolactone, epleronone |
| Inodilators | levosimendan, milrinone |
| Phosphodiester ase V inhibitors | sildenafil, tardalafil |
| Positive inotropes | levosimendan, milrinone, isoproterenol, dobutamine, dopamine, digoxin, digitoxin |
| Pressor agents | epinephrine, norepinephrine, phenylephrine |
| Vasodilators (including nitric oxide donors) | amoldipine, hydralazine, prazosin, nitroglycerine (including topical), isosorbide di-/mononitrate, other nitrates, nitric oxide, sodium nitroprusside, L-arginine |
| Other | iloprost, epoprostenol, bosentan known cardiotoxins (e.g. adriamycin) |
Permitted concomitant medications
| Type | Examples |
| Bronchodilators | aminophylline, theophylline, terbutaline |
| Antibiotics | All antibiotics allowed |
| Other | corticosteroids, cough suppressants, mirtazapine or other appetite stimulants, and anti-seizure medications |
Q1. Can I prescribe other medications upon diagnosis?
Heart medications such as ACE inhibitors and many other drugs are prohibited during the study (see the full list on this page). Dogs that have received a prohibited medication for 14 or more days are ineligible, and must not have received heart medications in the 30 days prior to enrollment. For clients interested in study participation and whose dogs are otherwise eligible, please do not prescribe any excluded medications until after study completion. All dogs in the study receive the test medication, so there is no chance an enrolled dog will go untreated.
Q2. How long will my canine patient participate in the study?
The study period is up to 365 days, during which 10 visits to the investigational site (four with the dog present) will be required by the owner.
Q3. What if I have additional questions about the medication or protocols used in this study?
Contact us via the toll-free number or the contact form. Also, participating investigators (veterinary cardiologists) can answer general questions not subject to confidentiality restrictions.
Q4. What is the investigational medication?
The investigational medication being tested is an inodilator. It is currently licensed to treat dogs with clinical signs of congestive heart failure (CHF), and this study is evaluating its safety and effectiveness when used at an earlier stage, Stage B2 MMVD.
Q5. Will some dogs be placed on placebo?
No, there is no placebo used in this study. All dogs will receive the investigational medication.
Q6. What if my participating client contacts me with questions about the study?
Please refer your client back to the investigator site for all questions related to the study.
Q7. After the study, could moving to a different treatment cause a canine patient’s condition to worsen?
This outcome has not been reported. You may wish to discuss options for further treatment of your canine patient’s CHF with the investigating cardiologist at the completion of your patient’s participation in the study.
Q8. Who will be responsible for transitioning the dog onto a treatment plan after the study is complete?
You, your client, and the investigator should discuss what is best for the client and the patient. Ultimately, the decision will be between you and your client.
Q9. How do the clinic credits work?
Upon your patient’s enrollment in the study, your client needs to complete this short post-enrollment form to provide the information necessary to receive clinic credits. After completion of study participation, owners of enrolled canine patients receive up to $500 in credit to spend on goods and services at their referring veterinary practice.
In order to receive payment of client credits at your hospital, please complete and forward an Acknowledgement Form and W-9 Tax Form to us. (Only one of each form is required, even if you have multiple patients enrolled in the study.) Owner incentives accumulate as the patient progresses through the study, up to a maximum incentive payment of $500 for a full 365 days of participation. The accumulated incentive is paid soon after the patient completes the study.
Q10. Why is my practice being required to complete a W-9 tax form in order to receive client credits from this study?
W-9 forms are a standard request when conducting business-to-business transactions. Visionaire Research & Education supports study sponsors in many ways, including processing client credit payments to veterinary practices on behalf of clinical studies that we support. Therefore, we request these tax forms in order to ensure we are in compliance with all IRS tax guidelines when acting on behalf of study sponsors.
The information included on the W-9 is used to generate a 1099 if total payments to a veterinarian or veterinary practice exceed $600 in a calendar year. Generally, if only one patient participates in a study, then the payment will be under $600. However, our tax advisors have directed us to obtain W-9 forms in all cases to ensure we are in compliance.