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A Pilot study to evaluate the effectiveness and safety of a new drug in the management of dogs with congestive heart failure caused by degenerative (myxomatous) mitral valve disease

Status: Recruiting

Species: Dog

Veterinary Speciality: Cardiology

Description

Congestive heart failure is a disease in which the heart cannot pump effectively, and fluid starts to back up, creating signs like cough, difficulty breathing, or fluid in the belly.  In older dogs, heart failure is a common condition that can be caused by aging changes in a heart valve (degenerative mitral valve disease).  This causes blood to leak backwards, causing a heart murmur. As the leak gets worse, the heart gets bigger and eventually fluid builds up in the lungs.  While the standard heart failure drugs can help for a while, newer drugs are needed to help dogs live longer with heart disease. This study will explore the effectiveness and safety of a daily oral dose of a new cardiac drug – related cardiac drugs have been shown to improve survival in people with heart failure.

Inclusion Criteria

  • Dogs diagnosed with ACVIM stage C or stage D heart failure due to mitral valve disease
  • Dogs on furosemide, at a minimum of 3.5 mg/kg/day, or the equivalent dosage of torsemide
  • Pimobendan, 0.25-0.3 mg/kg at least twice a day
  • A standard dosage of an approved ACE inhibitor, or Spironolactone, or both an ACE inhibitor and spironolactone

Exclusion Criteria

  • Dogs should have a fairly good appetite for 7 days prior to enrollment
  • Dogs younger than 4 years of age are excluded
  • Dogs with early heart disease, and dogs with advanced concurrent lung disease are to be excluded.
  • Dogs with uncontrolled heart failure are to be excluded, at least until the heart failure can be better controlled.
  • Dogs with a positive heartworm test are excluded
  • Dogs with moderate to severe kidney disease (creatinine >2.5 mg/dL) are excluded, as are dogs with marked liver enzyme elevation, and dogs with concurrent severe diseases like advanced cancer are excluded.
  • Dogs scheduled for any elective procedure that requires general anesthesia during the study period are to be excluded

Client Benefits

The study covers the costs of:

  • Once a month clinical examinations and tests at each clinic visit to manage and monitor the heart failure of your dog for 6 months, or as long as your dog stays in the study
  • The study medication
  • Veterinarian fees associated directly with the study (scheduled visits and costs required for the study)
  • The study will not cover the costs of diets or other drugs needed to manage heart failure in your dog

Sample or Data Requirements

Dogs will have clinical exams and blood samples collected on a once a month basis.  Owners will be required to keep a daily log throughout the duration of the trial as well as monthly surveys regarding quality of life.

Contact Info

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

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