Estudio DELAY

DELAY of Appearance of sYmptoms of canine degenerative mitral valve disease treated with Spironolactone and Benazepril.
Retrasar la aparición de síntomas en la patología degenerativa de la válvula mitral con un tratamiento de Espironolactona y Benazeprilo

El estudio DELAY es multicéntrico. El objetivo es saber si el tratamiento con Espironolactona y Benazepril puede retrasar la aparición de síntomas clínicos en perros asintomáticos que sufren una patología degeneratica de la válvula mitral y que ya presentan un aumento del tamaño cardiaco.

Hoy en día, los estudios multicéntricos representan el gold standard para la investigación los efectos de un tratamiento sobre una enfermedad.
Los dos fármacos incluidos en el estudio han sido ya aprobados para el tratamiento de los perros con insuficiencia cardiaca debido a la degeración de la válvula mitral.
El estudio DELAY quiere evaluar si comenzando el tratamiento en fases anteriores se puede retrar la aparición de síntomas y de esta manera prolongar la supervivencia y mejorar la calidad de vida de los pacientes.

El diseño del estudio ha sido realizado mediante la colaboración de un grupo de cardiólogos italianos y el protocolo ha sido aprobado por el Ministerio de Sanidad Italiano.

The canine degenerative mitral valve disease (CDVD) is the most common disease of the dog and it is more frequent in the small size dogs, being more than 8 years old.

Even if this disease has a benign course, the patients who present cardiac enlargement run a high risk to develop heart failure with consequent reduction in the quality and duration of life.

The scope of the treatment of the asymptomatic disease in dogs with cardiac enlargement, is to postpone the onset of the clinical signs and so to lengthen the period of very good quality of life of the dogs.

The scope of the Delay Study is to evaluate the efficacy of the treatment with Spironolactone and Benazepril in deferring the onset of the clinical signs in dogs with asymptomatic CDVD and cardiac enlargement. The results of this trial will allow to optimize the treatment of this important cardio-vascular disease in the dog.

DELAY is a blind placebo used multicentric clinical trial. This type of study is considered – from scientific point of view – the best one to evaluate the efficacy of a medical treatment. It is based on preliminary scientific data and the protocol has been approved by the Ministry of Health.

Both Spironolactone and Benazepril are drugs approved for the treatment of the CDVD combined with heart failure in the dog and have shown their efficacy and safety in the daily clinical practice.

The DELAY Study foresees the cooperation of 17 Italian veterinary centres with high professional qualification for the evaluation of the cardio-vascular diseases. The dogs involved in the study will be periodically carefully controlled in order to determine the disease progression.

All the enrolled dogs will take advantage of a highly qualified monitoring and you will always have available a Vet of reference for each possible problem you may have.

The DELAY is an important clinical trial. The results of this study will have positive consequences for thousands of patients as your dog. So, the participation of yr dog in this study can help many other dogs affected by the same problem.

In name of the DELAY Study Scientific Comittee - Dr. Michele Borgarelli, DVM, PhD, Diplomate ECVIM-CA (Cardiology)

HOW FREQUENT IS THE DISEASE IN DOG?

The CDVD is one of the diseases most frequently affecting the dogs. The risk to develop the disease is proportional to the age and involves 25% of the dogs having an age between 9 and 12 years.

In some breeds, such as Cavalier King Charles Spaniel, the prevalence of the disease reaches the share of 100% in dogs which are more than 10 years.

WHICH ADVANTAGES COULD I HAVE IF I ACCEPT THAT MY DOG PARTICIPATES IN THE DELAY?

The dogs included in the clinical trial DELAY are subject to periodical visits from vets with high professional qualification for the treatment of the cardio-vascular diseases.

Said visits are carried out according to the Internationals Guidelines for the diagnosis and the treatment of this disease. Consequently, your dog will be monitored in the best possible way, with the scope to evaluate the progression of the disease. For the duration of the trial, you can count on the qualified consultancy of the vets who participate in the study, and you can refer to them at any time for any problem you may have.

WHY SHOULD I ACCEPT TO INCLUDE MY DOG IN THE DELAY STUDY?

The results of the DELAY Study will allow to optimize the therapy of this important cardiac disease and the participation of your dog in the study will have positive consequences for thousands of sick dogs, allowing them to have a better life quality for a longer period.

WHICH TYPE OF COMMITMENT ENTAILS THE PARTICIPATION IN THE DELAY STUDY?

The participation in the DELAY entails that your dog is submitted to a check-up each 6 months. The periodical visits consist in a clinical visit, a chest X-ray, an echocardiography (each 12 months) and a blood/urine text. Moreover, each 3 months it is necessary to go back to the Veterinary Centre that has enrolled your dog, in order to collect the medicines for your dog.

For the success of the DELAY Study, it is important to administer the medicines every day to your dog. Even if the visits have to be carried out according to a precise timing, it is possible to be flexible when fixing the dates of the visits.

CAN I CHANGE OPINION, AFTER HAVIG SIGNED THE AGREEMENT TO INCLUDE MY DOG IN THE STUDY?

Yes, you have the right to decide to exclude your dog from the study, at any time and for any reason.

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