Biventricular Pacing in Hypertrophic Cardiomyopathy
Recruitment status was: Recruiting
Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced ability to exercise because of breatlessness, which can in some cases be severe. This appears in most cases to be due to an impairment of the filling of the heart, especially on exercise this limits the amount of blood the heart is able to pump. Several factors may contribute to this slow filling of the heart, including (1) The heart contracts and relaxes in an incoordinate way (called 'dyssynchrony') which is inefficient, and (2) The filling of the main pumping chamber (the left ventricle) may be impeded by high pressure in the other ventricle(the right ventricle)- in other words the left ventricle is 'squashed' by the right ventricle. This is known as diastolic ventricular interaction.
Although drugs can improve the filling of the heart and relieve symptoms, some patients remain very symptomatic despite these drugs.
The mechanisms responsible for the filling abnormality in patients with Hypertrophic Cardiomyopathy are similar to those seen in the much more common condition known as Heart Failure. A special type of pacemaker technique called 'Biventricular Pacing' has been shown to markedly improve symtoms in patients with heart failure. This form of pacing has been shown to improve both 'dyssynchrony' ( incoordination) and 'ventricular interaction' (squashed left heart) in patients with Heart Failure.
We propose that Biventricular pacing may similarly improve these abnormalities in patients with Hypertrophic Cardiomyopathy, resulting in an improvement of symptoms. The study will focus on patients with the condition who have severe symtoms despite being on optimal currently available drug therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Diastolic Ventricular Interaction and the Effects Of Biventricular Pacing in Hypertrophic Cardiomyopathy|
- Peak Exercise Oxygen Consumption. [ Time Frame: 4 month ]
- Myocardial Asynchrony Index [ Time Frame: 4 months ]
- Minnesota Quality of Life Questionnaire [ Time Frame: 4 months ]
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||August 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504647
|The Queen Elizabeth, University Hospital Birmingham|
|Birmingham, United Kingdom, B15 2TH|
|University Hospital of Wales|
|Cardiff, United Kingdom, CF14 4XW|
|The Heart Hospital|
|London, United Kingdom, W1G 8PH|
|Principal Investigator:||Michael P Frenneaux, MBBS(Hons)||University of Birmingham|