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Evaluating an appetite stimulant in dogs with weight loss from heart disease

Effectiveness of a new drug (capromorelin) in dogs with heart failure due to mitral valve disease and muscle loss

Sponsor: Cummings Seed Grant

Status: Recruiting

Species: Dog

Veterinary Speciality: Cardiology, Nutrition

Description

Degenerative mitral valve disease is the most common heart disease in dogs. In dogs that progress to congestive heart failure (CHF), cardiac cachexia (muscle loss) occurs frequently and reduces strength, immune function, and overall survival. Having a medication that could improve appetite, body weight, and muscle would be very beneficial for the dogs. Although a medication that improves these important issues might not alter the underlying heart disease, it could improve malnutrition and quality of life, which could have direct benefits on survival.

Capromorelin is drug that mimics the effects of a hormone called ghrelin. Ghrelin’s normal function in our body is to make us feel hungry, and also to increase lean body mass. Capromorelin was recently approved as an appetite stimulant in dogs so it has gone through extensively tested.

This study will evaluate whether capromorelin can reduce the loss of body weight, muscle, and appetite in dogs with CHF. Dogs will be randomized to receive either capromorelin or a placebo for 60 days (owners and investigators will not know which one). Dogs will be evaluated at baseline (Day 0), and on Days 30 and 60, for a total of 3 visits. Evaluation will include assessment muscle mass (by ultrasound), body weight, muscle condition score, body condition score, quality of life, appetite, 6-minute walk test, blood tests, and echocardiography (ultrasound of the heart).

Inclusion Criteria

  • Dogs with a confirmed diagnosis of congestive heart failure (CHF) due to degenerative mitral valve disease.
  • Stable management of CHF for at least 7 days prior to study enrollment (dogs requiring adjustment of medications to control clinical signs must have enrollment delayed until these clinical signs are controlled). Dogs must require at least approximately 2 mg/kg/day of furosemide to control signs of congestion and be on a stable dose for at least 7 days prior to enrollment. Dogs should also be taking an angiotensin converting enzyme inhibitor and/or pimobendan in addition to furosemide. Dogs may be receiving other medications to manage their heart disease, and may be taking cyproheptadine, mirtazapine, omega-3 fatty acids (fish oil), or glucosamine. Other dietary supplements may be allowed after review.
  • Any abnormal heart rhythms should be well controlled.
  • Evidence of at least moderate muscle loss on exam.
  • Owner must be willing to give the study medication as directed and to bring the dog in for all 3 required study visits.

Exclusion Criteria

  • Any dog intended for breeding or that is pregnant or nursing puppies.
  • Dogs less than 18 months of age.
  • Dogs with chronic kidney disease IRIS stage IV.
  • Dogs with CHF due to other heart diseases.
  • Dogs with serious uncontrolled abnormal heart rhythms.
  • Dogs with other major diseases.
  • Dogs receiving prohibited medications, such as steroids or chemotherapy drugs.

Client Benefits

The study will cover all of the costs associated with the planned measurements for the 3 study visits, including the cost of the capromorelin or placebo. If additional tests are needed based on your dog’s underlying heart failure, these will not be covered by the study. In addition to the benefits to you and your dog, your dog’s participation will also allow us to gain information which will help in the treatment of other dogs with heart failure.

Contact Info

For questions regarding the clinical trial please fill out this survey: Pet Eligibility Questionnaire

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