Cardiology

Clinical trials for Cardiology specialty

  • Description: Congenital heart defects occur in a variety of dog breeds, with the most common being the patent ductus arteriosus (PDA).  Although this is a correctable disorder in most puppies, it requires surgery or a catheter-based procedure which can be expensive and is not without risk.  Therefore, determining the genetic cause of PDA in dogs would be highly desirable so that dogs could be screened and the genetic mutation could be eventually bred out of the canine population.  Corgis are a breed at increased risk for PDAs, so the goal of this study is to evaluate Corgis with and without PDAs in order to identify the gene mutation for this heart problem.

    Inclusion Criteria:                                      

    Pembroke Welsh Corgis with a documented PDA will be studied.

    Exclusion Criteria:

    Breeds other than Pembroke Welsh Corgis.

    Client Benefits:

    The study will cover the cost of an echocardiogram (ultrasound of the heart) as well as a blood sample for DNA testing.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Description:

    Previous studies on laboratory mice show a decrease in growth differentiation factor 11 (GDF11) in the circulating blood of old mice with age-related myocardial hypertrophy compared with young mice with normal cardiac structure.  The goal of this study is to see if the same GDF11 deficiency is also seen in cats with hypertrophic cardiomyopathy (HCM).  We will be looking for cats with HCM and cats with normal heart structure to determine if there is a significant difference in the GDF11 concentration between the two groups.

    Inclusion Criteria:

    Cats with hypertrophic cardiomyopathy (HCM)

    Cats with normal heart structure

    Exclusion Criteria:

    Cats that become overly stressed or anxious during the echocardiogram

    Client Benefits:

    The study will pay for the cost of the exam and echocardiogram.  Your cat’s participation in the study will also allow us to gain information which will help in the management and treatment of other cats with HCM

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • Sponsor:  Private Foundation

    CSRC Protocol #: 027-14

    Fully enrolled

    Description:

    Currently, no medical treatments have been shown to delay the progression of chronic valvular disease (CVD) in dogs, which is a very common heart disease in dogs. In this disease, heart valves become thickened and can no longer keep blood from leaking backwards, leading to fluid accumulation in the lungs (congestive heart failure, CHF). Surgical repair of the valves has shown potential in reversing some changes from the heart disease and prolonging survival time, but this remains a relatively high-risk surgery that very few veterinary hospitals are capable of performing. The cost of the procedure is also financially prohibitive to most dog owners.

    If we can show that mesenchymal stem cell (MSC) treatment is not only safe but can delay the progression of CVD in dogs, this would be the first non-surgical treatment option available to our canine patients. Our results would also have particular relevance for those human patients who cannot undergo valve repair surgery due to unacceptable anesthetic or surgical risks.

    We hypothesize that MSC therapy is safe when administered intravenously (IV) to dogs in CHF, and MSC therapy will result in improved cardiac function as assessed by echocardiography, cardiac biomarkers, or the quality of life of the patient.

    Inclusion/Exclusion Criteria:                                                                      

    A total of 10 client-owned dogs of any sex or age with active CHF secondary to CVD to the Tufts Foster Hospital for Small Animals will be recruited for this clinical trial. Congestive heart failure will be confirmed on chest x-rays to verify the presence of pulmonary edema (fluid in the lungs).

    Dogs with chronic kidney disease, liver disease, uncontrolled hypothyroidism, cancer, high blood pressure, active infection, metabolic disorders, and autoimmune disease will be excluded from the study.

    Client Benefits:

    The study will cover all of the costs associated with echocardiograms, chest x-rays, bloodwork analysis, blood pressures, ECG monitoring, and recheck exam fees. It will not cover the initial hospitalization cost for congestive heart failure stabilization. It will also not cover any medication costs or costs related to disease of other organ systems. Your pet’s participation will allow us to gain information which will help in the treatment of other dogs with this CVD and CHF. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Description:

    The goal of this study is to develop a simple screening method, useful in practice, for the widespread detection of early cardiomyopathy in cats. Cardiac disease is particularly frustrating in cats, as cats may have normal heart sounds, but severe heart disease, or very abnormal heart sounds and no clinically significant disease. Echocardiography (ECHO) by a cardiologist is the gold standard for determination of heart disease in cats; however, ECHO is not widely available and may be cost –prohibitive. Biomarkers, specifically NT pro-BNP and troponin have been introduced and validated for documentation of heart disease in cats, but have not been widely evaluated in apparently healthy pet cats. Our goal is to teach a screening echo – Frontline Cardiac UltraSound –FOCUS to participants, and compare the predictive value of practitioner performed FOCUS exam, physical examination, EKG analysis and biomarker assessment for determining the presence or absence of heart disease with the gold standard of ECHO by a cardiologist.

    Inclusion Criteria:

     Animals to be included:

    a. Species: Feline

    b. Sex: Any

    c. Age Range any greater > 1 year

    d. Weight Range Any; expected to be greater than 4 kg.

     

    Client Benefits:

    The study will cover all of the costs of this study, physical exam, EKG, echocardiogram, biomarker blood test.  Your pet’s participation will also allow us to gain information that will help in the early identification of heart disease in cats. If we diagnose heart disease in your cat, we may be able to institute treatment earlier than we would otherwise have been able to do. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

     

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

  • Sponsor:  Private Foundation

    CSRC Protocol #: 029-14

    Enrollment beginning in February 2015

    Description:

    Cardiomyopathy is a common affliction of the Boxer breed that is manifested by serious ventricular arrhythmias, dilation and reduced vigor of contraction of the heart, or both. The arrhythmic form of the disease bears a striking resemblance to arrhythmogenic right ventricular cardiomyopathy (ARVC) in people, an important cause of sudden cardiac death in young human athletes that is characterized by replacement of the normal heart muscle by fat, scar tissue, and inflammation.

    Current treatment strategies focus on controlling symptomatic arrhythmias, however no medical treatment has been shown to prevent sudden cardiac death. Current therapies also fail to address the underlying structural changes in the heart muscle that inexorably progress, resulting in worsening arrhythmia, cardiac dilation and, in some patients congestive heart failure.

    Mesenchymal stem cells (MSCs) exert anti-inflammatory and anti-fibrotic effects that may prove useful in attenuating the inflammation and remodeling of the heart muscle that characterizes the disease, in turn improving arrhythmia frequency and potentially quality of life or survival times of dogs with ARVC. The major goal of this study is to evaluate preliminary safety of intravenous administration of MSCs in Boxers with ARVC, and to assess their effect on arrhythmia frequency, improving cardiac structural abnormalities, or prolonging survival in affected animals by reducing inflammation or deposition of scar tissue in the heart.

    Inclusion/Exclusion Criteria: 

    A total of 12 client-owned Boxers of any sex or age with cardiomyopathy will be enrolled in this study. Dogs with advanced congestive heart failure, clinically significant congenital heart disease, kidney or liver disease, cancer, active infection, or autoimmune disease will be excluded from the study.

    Client Benefits:

    The study will cover the costs for your dog’s bloodwork, echocardiogram, blood pressure measurement, ECG and Holter monitoring, 4 hours of observation and continuous ECG monitoring following the injection, and recheck visits during the 6 month study period. The study will also cover up to $500 of any costs incurred due to complications from the study; it will not cover any other medication or hospitalization costs. Your pet’s participation will allow us to gain information which will help in the treatment of Boxers and potentially people with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • Sponsor: Private Foundation

    IACUC protocol#: G2015-56

    Currently Recruiting

    Description:

    The goal of this study is to evaluate biomarkers in urine as measures of cardiac health.  Specifically, we will compare extracellular miRNA (‘micro RNA’) content of urine from healthy dogs, dogs with mitral valve disease, and dogs with renal disease (see criteria below).

    These studies will improve our knowledge of how extracellular miRNA reflects damage to the heart, versus damage from heart medications to the kidney.

    Inclusion Criteria:

    There will be four populations in this study:

    Group 1: Healthy adult dogs (8+ years) with no cardiac disease (no murmur)

    Group 2: Dogs with mitral valve disease and not in congestive heart failure

    Group 3: Dogs with mitral valve disease in congestive heart failure

    Group 4: Dogs with kidney injury but without cardiac disease (azotemia and no heart murmur)

    Client Benefits:

    The owner’s participation in this study will allow us to gain information about the benefits of using urine (a readily available, non-invasive source) to screen for heart disease and associated renal damage. In addition, the biomarkers (signals) we find may help veterinarians determine the effectiveness of treatments in their patients over time.  You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Sponsor: Private Foundation

    IACUC protocol#: G2015-58                                                                                                                                 Currently Recruiting

    Description:

    The goal of this study is to compare plasma biomarkers in the form of extracellular RNA in dogs with mitral valve disease presenting with versus without congestive heart failure.

    This study will be an important step towards making exosome analysis a useful and readily available tool for evaluating the progression, the molecular basis for remodeling, and development of specific therapies for mitral valve disease.

    Inclusion/exclusion criteria:

    All dogs should be over eight years of age in order to control for age related differences.

    Healthy: for controls the dogs will be defined as a healthy animal with a normal physical exam, normal CBC/chemistry panel/UA and no evidence of a heart murmur as documented by a veterinarian

    There will be four populations that will be included in this study:

    • Group 1: Healthy dogs with no cardiac disease
    • Group 2: Dogs with mitral valve disease not in congestive heart failure.
    • Group 3: Dogs with mitral valve disease in congestive heart failure.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Sponsor: Private Foundation                                                                                                                   CSRC Protocol#: 002.15                                                                                                              Recruitment beginning July 2015

    Description:

    Cardiomyopathy is a common affliction of Boxer dogs that is manifested by serious ventricular arrhythmias, cardiac dilation and reduced pump function, or both. The arrhythmic form of the disease bears a striking resemblance to arrhythmogenic right ventricular cardiomyopathy (ARVC) in people, an important cause of sudden cardiac death in young human athletes that is characterized by replacement of the normal heart muscle by fat, scar tissue, and inflammation. ARVC can be challenging to diagnose.  Genetic testing is imperfect and ARVC screening usually entails a combination of family history, genetic testing, electrocardiographic and echocardiographic findings.

    The development of blood-based cardiac biomarkers has revolutionized the way in which we screen for certain types of heart disease. MicroRNAs (miRNAs) are small non-coding RNAs that play important roles in modifying gene expression. MiRNA gene expression patterns are altered in several types of cardiac disease in people and miRNA-based therapeutics are an area of active research. MiRNAs are uniquely suited to serve both as non-invasive biomarkers of disease and also potential therapeutic targets.

    The goals of this pilot study are twofold: 1) to determine the feasibility of measurement of miRNAs from circulating exosomes in canine peripheral blood samples; and 2) to compare expression patterns of candidate miRNAs between normal Boxers and Boxers affected with ARVC. We hypothesize that measurement of miRNAs from within exosomes circulating in canine plasma will be feasible, miRNA will be enriched in the exosome rather than the non-exosomal fractions, and furthermore that Boxers affected with ARVC will have altered miRNA expression patterns relative to age- and breed-matched healthy controls.

    16 Boxers – 8 Normal, 8 with ARVC

    Inclusion Criteria:

    Normal boxers:           > 5 years of age

    < 50 VPCs/24 hr on Holter monitor

    Boxers with ARVC:      Any age with ≥500 VPC/24 hr on a Holter monitor or

    Ventricular ectopy sufficiently severe to begin antiarrhythmic therapy

    Exclusion criteria:

    Dogs with ACVIM Class C or D congestive heart failure, and those with clinically significant congenital heart disease, advanced renal or hepatic disease, diabetes mellitus, malignant neoplasia, active infection, or autoimmune disease will be excluded from the study.

    Administration of antiarrhythmics or other cardiac medications deemed necessary by each dog’s clinical condition will not preclude enrollment in the study.

    Client Benefits:

    The study will cover the costs for your dog’s bloodwork, echocardiogram, ECG, and Holter monitor today. Your pet’s participation will also allow us to gain information which will help in the diagnosis and treatment of other Boxers with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • Description:

    Degenerative mitral valve disease (DMVD) is the most common form of heart disease in the dog, accounting for more than 70% of cardiac disease and affecting at least 11% of all dogs (and up to 90% of certain breeds, such as the Cavalier King Charles Spaniel). Some breeds of dogs are genetically predisposed to DMVD, but genetics do not completely explain the disease and its progression. Research on factors that may increase the risk for heart disease in genetically predisposed individuals is underway in both people and companion animals, and includes factors such as diet, exercise, and hormones. This is particularly important in people where heart disease is a leading cause of death.

    Recently, a compound called trimethylamine N-oxide (TMAO) has received a great deal of attention due to its association with heart disease in people. Trimethylamine N-oxide is produced when the bacteria in people’s intestines metabolize nutrients in the diet, such as choline and L-carnitine. High levels of TMAO, choline, and L-carnitine in the blood have all been shown to be associated with increased risk of heart disease and death from heart disease in people.

    Based on the recent research on TMAO in people, the investigators have begun evaluating its role in canine heart disease.  It is unknown if blood levels of TMAO, choline, or L-carnitine are different in dogs with DMVD compared to healthy controls. Nor is it known if these levels differ in dogs with DMVD with and without congestive heart failure (CHF). Therefore, the goal of the proposed study is to identify whether the higher blood levels of TMAO, choline, and L-carnitine found in people with heart disease also occur in dogs with DMVD, and if the levels in dogs with CHF are higher than in those without CHF.

    Inclusion Criteria:

    • Dogs with asymptomatic DMVD
    • Dogs with DMVD and CHF
    • Age- and breed-matched healthy control dogs.

    Exclusion Criteria:

    • Dogs currently receiving other non-cardiac medications (except monthly parasite preventative medication, which will be allowed),
    • Dietary supplements containing carnitine, choline, precursors of carnitine or choline, or supplements that might modify gut microflora (e.g., probiotics) will be excluded.
    • Dogs in the control group and in the asymptomatic DMVD group with a serum creatinine >2.1 mg/dL will be excluded
    • Dogs in the DMVD CHF group with a serum creatinine > 2.4 mg/dL will be excluded.
    • Dogs with other major diseases (e.g., cancer, diabetes mellitus) will also be excluded.

    Client Benefits:

    The study will cover the costs of hospital registration, a cardiology consultation or appointment, and echocardiogram, blood testing (complete blood count, biochemistry profile, and measurement of TMAO, choline, and carnitine). Your dog’s participation will also allow us to gain information about the cause of this disease which will help in the treatment of other dogs with this condition. You understand that your dog’s participation in this study may not alleviate or cure his or her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu