Trimetazidine Therapy in Hypertrophic Cardiomyopathy
Palabras clave
Abstracto
Descripción
BACKGROUND:
Hypertrophic cardiomyopathy (HCM) is a common inherited disorder of heart muscle affecting 1 in 500 individuals worldwide. It is associated with arrhythmias, heart failure and sudden death in young people. In the majority of patients, HCM is caused by mutations in genes encoding cardiac contractile proteins. It has been hypothesised that excessive sarcomeric energy consumption is an important and early factor in the pathophysiology of HCM. Therefore modulation of myocardial metabolism presents a novel target for improving myocardial performance and symptoms in patients with HCM. Trimetazidine is an anti-anginal agent which like perhexiline reduces fatty acid oxidation and increases glucose oxidation, thus increasing the efficiency of energy production. Trimetazidine has been shown to significantly improve exercise performance in patients with stable angina, ischaemic and non ischaemic cardiomyopathy, either as monotherapy or in combination with beta-blockers or calcium channel blockers,
DESIGN: A single centre prospective randomised, double blind, placebo-controlled, trial of trimetazidine therapy.
DOSING: 20 mg Trimetazidine or Placebo three times daily for three months
METHODS: The following assessments will be made at baseline and after 3 months treatment: history and physical examination, Minnesota heart failure questionnaire, fasting blood tests, electrocardiogram, echocardiogram, cardiopulmonary exercise test, six minute walk test, 24 hour ECG Holter monitor.
fechas
| Verificado por última vez: | 07/31/2011 |
| Primero enviado: | 09/26/2012 |
| Inscripción estimada enviada: | 09/27/2012 |
| Publicado por primera vez: | 09/30/2012 |
| Última actualización enviada: | 02/26/2013 |
| Última actualización publicada: | 02/27/2013 |
| Fecha de inicio real del estudio: | 03/31/2012 |
| Fecha estimada de finalización primaria: | 03/31/2014 |
| Fecha estimada de finalización del estudio: | 03/31/2014 |
Condición o enfermedad
Intervención / tratamiento
Drug: Trimetazidine
Other: Placebo capsule
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Trimetazidine | Drug: Trimetazidine Trimetazidine 20mg three times per day for 3 months |
| Placebo Comparator: Placebo capsule | Other: Placebo capsule one capsule three times per day for 3 months |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Non-obstructive hypertrophic cardiomyopathy (gradient <30 mmHg at rest) - NYHA (New York Heart Association) Class ≥ 2 - Peak VO2 (maximal oxygen consumption) ≤80% predicted for age and gender - Heart rate < 90/minute at rest Exclusion Criteria: - Diabetes Mellitus - Abnormal renal function (GFR<60ml/min) or hepatic impairment - Female who is pregnant, lactating or planning pregnancy during the course of the study |
Salir
Medidas de resultado primarias
1. Peak oxygen consumption [3 months]
Medidas de resultado secundarias
1. Left ventricular function [3 months]
2. Symptom status [3 months]
3. Arrhythmia [3 months]
4. Cardiac biomarkers [3 months]
5. Exercise capacity [3 months]
