Impact of spontaneous heart disease on activity in dogs
Client Information and Consent Form
A clinical study sponsored by the North Carolina State University College of Veterinary Medicine and the Barry and Savannah French-Poodle Memorial Fund.
Thank you for your interest in this study! This page will provide you with information about the study and what it will mean for you and your pet. Please read it carefully and feel free to ask any questions you might have. Participation in this study is voluntary – you are under no obligation to do so, and if you decide not to participate, it will not affect you or your pet’s access to care in any way.
Purpose of this study: This study is being undertaken to better understand the effect of heart disease on the quality of life in dogs. Freedom of movement and activity are important contributors to a good quality of life in humans, and we believe that the same is true for companion animals. Moderate-to-severe heart failure reliably impairs mobility in humans, and poor mobility predicts a poor prognosis in these people. We suspect that the same is true in dogs.
Recently we have proven that a small device called an accelerometer, which can be worn on a collar in even small dogs, provides accurate measurement of activity in dogs. The goal of this study is to use this device to record the activity of your dog at home for 2 weeks, and compare the activity record between dogs with early, mild heart disease with the activity of dogs without heart disease. We hope to determine if mild heart disease causes any measurable impairment of activity, and use this information in the future as a basis for studying the value of heart failure treatments in dogs with more severe heart disease. Additionally, if your pet has heart disease, we may ask to measure his activity for an additional 2 weeks, during which time we will ask you to treat with either a placebo (sugar pill) or a heart medication (enalapril) that is routinely used now as a ‘first-line’ treatment for this disorder. We hope to determine if this drug improves activity in dogs with early heart disease even if you have not noticed any signs of problems.
Description of the study: Dogs enrolled in the study will have heart disease (causing a murmur) but have not yet developed signs of heart failure. We will also enroll dogs of similar breed, size and age but without significant heart disease.
For dogs with heart disease, your veterinarian will obtain basic health screening information to confirm that your pet has heart disease, has no limping and is otherwise relatively healthy. Those tests must include a physical examination, blood and urine tests (complete blood count, chemistry profile, thyroid check, and urinalysis), and thoracic radiographs (chest x-ray). Once your veterinarian has performed a vertebral heart score and confirmed it measures >10.6, you will have an appointment with the Cardiology Service at the Veterinary Health Complex for an examination and a diagnostic echocardiogram. The study will pay for both the Cardiology service exam fee and the echocardiogram. At the conclusion of the appointment we will fit your dog with a collar outfitted with an accelerometer.
For control dogs (no heart disease), we will need to obtain basic health screening information to confirm that your dog is healthy and free from heart disease. Those tests must include a physical examination, blood and urine tests (complete blood count, chemistry profile, thyroid check, and urinalysis), and thoracic radiographs (chest x-ray).
Once we confirm that your dog is healthy we will interview you with 3 questionnaires and fit your dog with a collar that holds a small activity measurement device called an accelerometer. At the end of 15 days, you will return the collar and complete 1 last interview, at which time the study is complete!
We will require 4 things from you for the next two weeks:
- Your schedule remains the same (no vacations/boarding or other major disruptions in your dog’s lifestyle)
- You will need to fill out some questionnaires about your dog’s activity and general health
If your pet has heart disease, we will need you to return for a brief follow-up visit in 2 weeks. At that time we will ask you to begin daily administration of either a medication (enalapril) or placebo (sugar pill) for an additional 2 weeks. We will require that your dog wear the accelerometer during this time, that you complete another questionnaire about his health, and that you mail the device back to us.
Possible risks and benefits: All of the tests performed for the purposes of this study are part of a general health screen for older dogs, particularly if they have signs of heart disease. The study will pay for the cardiology exam and echocardiogram (for heart disease dogs). If we determine that your dog’s heart problem is serious enough to require medication right away, he will not be included in the study and your doctor will recommend proper treatment. If included in this study your dog will need to wear the collar at all times. The accelerometer (which is designed to be worn by people) unit does not emit any electrical or chemical energy to harm your pet. More information about the accelerometer may be found at the manufacturer’s web site, http://minimitter.respironics.com/actical_animal.cfm.
We hope that this study will provide veterinarians with new information concerning heart disease in dogs, and provide a sound basis for studying the effects of heart failure treatments in the future.
Confidentiality: Your medical records here remain the confidential property of the NCSU Veterinary Teaching Hospital and are treated with the same confidentiality as all of our patients.
Right to withdraw from the study: If for any reason the investigators feel that your dog is not a good subject for the study the investigators reserve the right to drop your dog from this study. Possible reasons for exclusion from the study include, but are not limited to:
- Your dog is easily distressed by routine handling.
- Your dog develops new illnesses during the study
Similarly, you have the right to withdraw your pet for any reason from the study after enrollment. In that case, you then will then be responsible for the cost of the tests that would have otherwise been paid for by the study.
Financial obligations: The study will pay for the cardiology exam and echocardiogram (for heart disease dogs) or $300 towards the cost of the health screen by your veterinarian (healthy control dogs). Reimbursement for healthy control dog participation will be made after completion of the 2-week accelerometer recording. If your pet requires treatments or tests not related to the study as described above you will be responsible for those costs. If you withdraw your pet the study for any reason against our advice, you will be responsible for the costs of the tests covered by the study.
Contact personnel: The veterinarian in charge of this study is Dr. Bernie Hansen at the NCSU College of Veterinary Medicine. If you have questions or concerns that can not be satisfied here, you may call his office at 919.513.6658, the study technician at the number below. NCSU’s Institutional Animal Care and Use Committee approved the protocol for this study.
- Andrea Thomson, Research Technician in the Comparative Pain Research Lab (office: 919-513-6854)