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CLINICAL TRIALS
University of Florida Veterinary Research
Investigation into Diet-Associated Dilated Cardiomyopathy in Dogs
The University of Florida, College of Veterinary Medicine is currently recruiting dogs with Dilated Cardiomyopathy (DCM) for a clinical research trial. This study will evaluate the effect of diet on DCM.
Dilated Cardiomyopathy (DCM) is a serious disease whereby the heart becomes weak and enlarged. Dogs may have symptoms of heart failure and can have a shortened lifespan with DCM. Recent reports suggest that there may be a relationship between certain dog foods and DCM. Some affected dogs have improved when their diets are changed, supporting the role of food in this disease process. The purpose of this study is to investigate this potential relationship, and to determine if improvement in heart function occurs with a change in diet.
For more information on this issue:
https://www.fda.gov/AnimalVeterinary/NewsEvents/ucm630993.htm
https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm613305.htm
https://research.vetmed.ufl.edu/clinical-trials/small-animal/investigation-into-diet-associated-dilated-cardiomyopathy-in-dogs/
- Inclusion Criteria:
- Dogs with DCM (with or without congestive heart failure)
- Dogs can be of breeds typically predisposed to DCM (e.g. Doberman Pinschers, Boxers, Irish Wolfhounds, and Great Danes) or atypical breeds not usually predisposed to DCM
- Dogs can be eating any diet at the time of diagnosis, but owners should be willing to change the diet to one recommended by the University of Florida (one of several high-quality, reduced sodium, foods made by well-established manufacturers)
- Dogs must still be on their original diet at the time of study enrollment
- All visits take place at the University of Florida, Veterinary Hospital
- Exclusion criteria:
- Dogs that have already changed their diet
- Dogs less than 3 kg (6.6 lbs)
- Procedures: Dogs enrolled in the study will have a physical examination, ultrasound of the heart (echocardiogram), electrocardiogram, and blood tests (including complete blood count, biochemistry profile, taurine concentrations, NT-proBNP and troponin I). Dogs will then be transitioned to one of several recommended commercial diets and reexamined 3, 6 and 9 months later. Dogs that are deficient in taurine (as determined by blood tests) will be supplemented with taurine.
- Costs: The first step is to schedule an evaluation appointment by the Cardiology Service to determine if your dog will qualify for the study. If your dog is eligible for the study at the time of the evaluation, the study will cover the costs of the echocardiogram, electrocardiogram, and blood tests. These costs will be covered by the study at each evaluation (enrollment, 3 months, 6 months and 9 months). The costs of other tests, hospitalization, or medications are not covered by the study, nor is financial incentive provided.
- Contact: Contact the Cardiology Staff at the Small Animal Hospital 352-392-2235 or Dr. Darcy Adin by email at adind@ufl.edu.
- Principal Investigator: Dr. Darcy Adin
Dilated Cardiomyopathy (DCM) is a serious disease whereby the heart becomes weak and enlarged. Dogs may have symptoms of heart failure and can have a shortened lifespan with DCM. Recent reports suggest that there may be a relationship between certain dog foods and DCM. Some affected dogs have improved when their diets are changed, supporting the role of food in this disease process. The purpose of this study is to investigate this potential relationship, and to determine if improvement in heart function occurs with a change in diet.
For more information on this issue:
https://www.fda.gov/AnimalVeterinary/NewsEvents/ucm630993.htm
https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm613305.htm
https://research.vetmed.ufl.edu/clinical-trials/small-animal/investigation-into-diet-associated-dilated-cardiomyopathy-in-dogs/
University of Florida
Vet School/Small Animal Hospital
DCM CLINICAL TRIAL (NEW)
What: New Doberman DCM Clinical Trial.
Where: University of Florida Vet School
When: NEW (Start Date of this Trial is PENDING but they hope to begin soon).
How: You must take your dog into the UF Vet School Clinic for an initial exam (cost to you = $200).
Inclusion Criteria:
Value of Participating in the Study: Estimated at $5,000.
NOTE: You must pay the cost of thoracic radiographs is they have not been provided by your veterinarian.
Contact: Contact the Cardiology Service at the Small Animal Hospital 352-392-2235
Prior to setting an appointment, you are STRONGLY encouraged to email Dr. Sleeper (margaretmsleeper@ufl.edu) so she can pre-screen you as a potential candidate and clarify any fees you might incur.
Study Details:
At enrollment, an antibody titer, hematology and biochemistry panel will be used for screening purposes. Dogs will undergo a 3-minute electrocardiogram (ECG), a complete echocardiogram (ECHO) and the owners will complete a quality of life questionnaire. In order to participate in the study, dogs fulfilling the requirements will be randomly assigned to one of two groups: the placebo arm (cardiac injection with saline) or the gene therapy group (cardiac injection with the virus vector: AAV2/6-ARC-s100a1). Standard medical management for DCM and congestive heart failure will continue throughout the study in all dogs (pimobendan, angiotensin converting enzyme inhibitor and diuretic therapy). Saline instead of empty virus will be used as the placebo so that control dogs can undergo gene delivery if the treatment group demonstrates a significant improvement compared to the placebo group. Owners will need to commit to re-evaluations at 2, 4, 6, 9, and 12 months at the University of Florida following therapy.
Read more here: http://research.vetmed.ufl.edu/…/small-an…/dcm-in-dobermans/
Where: University of Florida Vet School
When: NEW (Start Date of this Trial is PENDING but they hope to begin soon).
How: You must take your dog into the UF Vet School Clinic for an initial exam (cost to you = $200).
Inclusion Criteria:
- A diagnosis of DCM and previous evidence of congestive heart failure which has been controlled by medical management
- A circulating neutralizing antibody titer to the virus vector of less than 1:20
- Clear of extra-cardiac disease, congenital heart disease or primary mitral valvular disease
- Owner agreement to authorize participation with informed consent and collection of the heart following euthanasia or death from any cause.
- Approximately $200 initial exam (paid by you).
Value of Participating in the Study: Estimated at $5,000.
NOTE: You must pay the cost of thoracic radiographs is they have not been provided by your veterinarian.
Contact: Contact the Cardiology Service at the Small Animal Hospital 352-392-2235
Prior to setting an appointment, you are STRONGLY encouraged to email Dr. Sleeper (margaretmsleeper@ufl.edu) so she can pre-screen you as a potential candidate and clarify any fees you might incur.
Study Details:
At enrollment, an antibody titer, hematology and biochemistry panel will be used for screening purposes. Dogs will undergo a 3-minute electrocardiogram (ECG), a complete echocardiogram (ECHO) and the owners will complete a quality of life questionnaire. In order to participate in the study, dogs fulfilling the requirements will be randomly assigned to one of two groups: the placebo arm (cardiac injection with saline) or the gene therapy group (cardiac injection with the virus vector: AAV2/6-ARC-s100a1). Standard medical management for DCM and congestive heart failure will continue throughout the study in all dogs (pimobendan, angiotensin converting enzyme inhibitor and diuretic therapy). Saline instead of empty virus will be used as the placebo so that control dogs can undergo gene delivery if the treatment group demonstrates a significant improvement compared to the placebo group. Owners will need to commit to re-evaluations at 2, 4, 6, 9, and 12 months at the University of Florida following therapy.
Read more here: http://research.vetmed.ufl.edu/…/small-an…/dcm-in-dobermans/
RESEARCH FINDINGS
European Society of Veterinary Cardiology Screening Guidelines for Dilated Cardiomyopathy in Doberman PinschersG Wess et al. J Vet Cardiol 19 (5), 405-415. 2017 Sep 29.
DATE: September 29, 2017 BACKGROUND: Dilated cardiomyopathy (DCM) is the most common cardiac disease in large breed dogs and is inherited in Doberman Pinschers with a high prevalence (58%). OBJECTIVE: The European Society for Veterinary Cardiology convened a task force to formulate screening guidelines for DCM in Dobermans. RECOMMENDATIONS: Screening for occult DCM in Dobermans should start at three years of age and use both Holter monitoring and echocardiography. Yearly screening over the life of the dog is recommended, as a one-time screening is not sufficient to rule out future development of DCM. The preferred echocardiographic method is the measurement of the left ventricular volume by Simpson's method of discs (SMOD). Less than 50 single ventricular premature complexes (VPCs) in 24 h are considered to be normal in Dobermans, although detection of any number of VPCs is cause for concern. Greater than 300 VPCs in 24 h or two subsequent recordings within a year showing between 50 and 300 VPCs in 24 h is considered diagnostic of occult DCM in Dobermans regardless of the concurrent echocardiographic findings. The guidelines also provide recommendations concerning ancillary tests, that are not included in the standard screening protocol, but which may have some utility when recommended tests are not available or financially untenable on an annual basis. These tests include assay of cardiac biomarkers (Troponin I and N-Terminal pro-B-type Natriuretic Peptide) as well as a 5-min resting electrocardiogram (ECG). CONCLUSION: The current guidelines should help to establish an early diagnosis of DCM in Dobermans. Read more here: http://www.sciencedirect.com/science/article/pii/S1760273417300619?via%3Dihub Good Summary of DCM in DobermansPrevious Research from MunichTo read past research from the Department of Animal Cardiology at LMU Munich, click here.
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This video may be a good primer to watch before you read the article below.
PDK4 Deficiency Induces Intrinsic Apoptosis in Response to Starvation in Fibroblasts from Doberman Pinschers with Dilated Cardiomyopathy.December 1, 2017
Taggart K, Estrada, Thompson, Lourenco, Kirmani, Suzuki-Hatano S, Pacak CA. Department of Small Animal Clinical Sciences, College of Veterinary Medicine, University of Florida, Gainesville, Florida. Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida. Abstract: The Doberman pinscher (DP) canine breed displays a high incidence of idiopathic, nonischemic dilated cardiomyopathy (DCM) with increased mortality. A common mutation in DPs is a splice site deletion in the pyruvate dehydrogenase kinase 4 (PDK4) gene that shows a positive correlation with DCM development. PDK4, a vital mitochondrial protein, controls the switch between glycolysis and oxidative phosphorylation based upon nutrient availability. It is likely, although unproven, that DPs with the PDK4 mutation are unable to switch to oxidative phosphorylation during periods of low nutrient availability, and thus are highly susceptible to mitochondrial-mediated apoptosis. This study investigated cell viability, mitochondrial stress, and activation of the intrinsic (mitochondrial mediated) apoptotic pathway in dermal fibroblasts from DPs that were healthy (PDK4wt/wt), heterozygous (PDK4wt/del), and homozygous (PDK4del/del) for the PDK4 mutation under conditions of high (unstarved) and low (starved) nutrient availability in vitro. As hypothesized, PDK4wt/del and PDK4del/del cells showed evidence of mitochondrial stress and activation of the intrinsic apoptotic pathway following starvation, while the PDK4wt/wt cells remained healthy and viable under these conditions. Adeno-associated virus (AAV) PDK4-mediated gene replacement experiments confirmed cause-effect relationships between PDK4 deficiency and apoptosis activation. The restoration of function observed following administration of AAV-PDK4 provides strong support for the translation of this gene therapy approach into the clinical realm for PDK4-affected Dobermans. Read More Here: www.ncbi.nlm.nih.gov/pubmed/29285418 |
Cancer News/Research/Trials
USDA Grants Canine Osteosarcoma Vaccine With Conditional License
DATE: October 5, 2018
SUMMARY: Osteosarcoma is the most common primary bone tumor in dogs, but a new vaccine is striving to change that narrative. Aratana Therapeutics, a company focused on innovative therapeutics for dogs and cats, announced that their Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014), has been granted a conditional license by the United States Department of Agriculture (USDA) Center for Veterinary Biologics.
The vaccine uses a listeria-based antigen delivery system that activates cytotoxic T-cells. This directs the T-cells to fight off cancer cells—capitalizing on the dog’s immune system and its ability to attack bacterial infections.
Read more here:
http://www.americanveterinarian.com/news/usda-grants-canine-osteosarcoma-vaccine-with-conditional-license
SUMMARY: Osteosarcoma is the most common primary bone tumor in dogs, but a new vaccine is striving to change that narrative. Aratana Therapeutics, a company focused on innovative therapeutics for dogs and cats, announced that their Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014), has been granted a conditional license by the United States Department of Agriculture (USDA) Center for Veterinary Biologics.
The vaccine uses a listeria-based antigen delivery system that activates cytotoxic T-cells. This directs the T-cells to fight off cancer cells—capitalizing on the dog’s immune system and its ability to attack bacterial infections.
Read more here:
http://www.americanveterinarian.com/news/usda-grants-canine-osteosarcoma-vaccine-with-conditional-license