Pimobendan Randomized Occult DCM Trial to Evaluate Clinical symptoms & Time to heart failure

Veterinarian and Dog Owner Information

As part of a joint United Kingdom/Canadian study, Dobermann dogs and bitches between 5 and 9 years of age (inclusive) are being screened free-of-charge by recognised veterinary cardiologists to determine whether these animals have evidence of preclinical (i.e. early) dilated cardiomyopathy (DCM). The purpose of the screening study is twofold; firstly to learn more about the disease in the breed, and secondly to identify Dobermanns for inclusion in a clinical study to assess the 
 potential benefit of pimobendan in Dobermanns with preclinical DCM.

Pimobendan is known to improve the survival times of Dobermanns with clinical signs of congestive heart failure resulting from dilated cardiomyopathy. There is, however, a significant time period in which the heart is diseased before the obvious outward signs of heart failure develop. Currently, there is no widely accepted medical therapy for dogs in this early, symptom-free (preclinical) phase of the disease.

The aim of the trial is to assess whether pimobendan delays the onset of clinical signs arising from DCM when therapy is initiated in the preclinical phase. An additional aim is to demonstrate whether this early therapy improves long-term survival of the Dobermann with DCM. When enrolled into the clinical study, each dog will receive either pimobendan or a placebo. Pimobendan is licensed for the treatment of canine congestive heart failure resulting from DCM but not yet for preclinical DCM, as no trials have yet been undertaken involving treatment of Dobermanns with evidence of preclinical disease. During the trial, the veterinary cardiologist and owner will be unaware (blinded, i.e. not informed) as to whether a dog is receiving pimobendan or placebo, so that the potential benefits of the study drug can be assessed without bias. This is normal procedure in studies of this type, conducted to Good Clinical Practice guidelines. The veterinary cardiologist will re-examine each dog 1 month after enrolment and thereafter every 6 months for the blinded phase of the study period. These examinations, along with the pimobendan or placebo will be provided free-of-charge. Owners should, of course, contact their own veterinarian at any time if they have any questions or concerns about the health of their pet. If a dog requires other veterinary attention during the study, then the owner will be responsible for all fees incurred. If enrolled for the main study, your dog will, on two occasions, be fitted with a 24-hour heart monitor carried on a harness. A credit card number will be required as a guarantee during the time the heart monitor is in your possession. If a dog develops clinical signs of congestive heart failure during the study, the blinding will be removed and the veterinary cardiologist and/or primary (dog owner’s own) veterinarian will prescribe additional medications and/or procedures that are deemed appropriate for the overall care of the dog. From that point onwards, until the end of the study, owners will still be eligible to receive pimobendan treatment free -of-charge for their dog, but will themselves be responsible for other costs. Owners will naturally have the option, at any time, to withdraw their pet from the study should they so desire.

  Participating Vets