Biventricular Pacing in Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504647
Recruitment Status : Unknown
Verified July 2007 by University Hospital Birmingham.
Recruitment status was:  Recruiting
First Posted : July 20, 2007
Last Update Posted : July 20, 2007
British Heart Foundation
Information provided by:
University Hospital Birmingham

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Device: Biventricular Pacemaker Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Diastolic Ventricular Interaction and the Effects Of Biventricular Pacing in Hypertrophic Cardiomyopathy
Study Start Date : June 2006
Estimated Study Completion Date : August 2008

Primary Outcome Measures :
  1. Peak Exercise Oxygen Consumption. [ Time Frame: 4 month ]

Secondary Outcome Measures :
  1. Myocardial Asynchrony Index [ Time Frame: 4 months ]
  2. Minnesota Quality of Life Questionnaire [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Hypertrophic Cardiomyopathy
  • Ability to perform peak exercise oxygen consumption test.

Exclusion Criteria:

  • Left ventricular outflow tract gradient more than 30mmHg
  • Peak Oxygen consumption more than 75% of maximum predicted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504647

Contact: Ibrar Ahmed, MBChB 44(0) 121 414 5916
Contact: Frenneaux P Frenneaux, MBBS(Hons) 44(0)121 414 6926

United Kingdom
The Queen Elizabeth, University Hospital Birmingham Recruiting
Birmingham, United Kingdom, B15 2TH
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
The Heart Hospital Recruiting
London, United Kingdom, W1G 8PH
Sponsors and Collaborators
University Hospital Birmingham
British Heart Foundation
Principal Investigator: Michael P Frenneaux, MBBS(Hons) University of Birmingham Identifier: NCT00504647     History of Changes
Other Study ID Numbers: 05/Q2707/352
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: July 20, 2007
Last Verified: July 2007

Keywords provided by University Hospital Birmingham:

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases