Biventricular Pacing in Hypertrophic Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University Hospital Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
British Heart Foundation
Medtronic
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00504647
First received: July 18, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention Phase
Hypertrophic Cardiomyopathy
Device: Biventricular Pacemaker
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Diastolic Ventricular Interaction and the Effects Of Biventricular Pacing in Hypertrophic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham:

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

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

Estimated Enrollment: 30
Study Start Date: June 2006
Estimated Study Completion Date: August 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504647

Contacts
Contact: Ibrar Ahmed, MBChB 44(0) 121 414 5916 01ahmedi@gmail.com
Contact: Frenneaux P Frenneaux, MBBS(Hons) 44(0)121 414 6926 m.p.frenneaux@bham.ac.uk

Locations
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
Medtronic
Investigators
Principal Investigator: Michael P Frenneaux, MBBS(Hons) University of Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00504647     History of Changes
Other Study ID Numbers: 05/Q2707/352
Study First Received: July 18, 2007
Last Updated: July 18, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Birmingham:
Hypertrophic
Cardiomyopathy
Diastolic
Ventricular
Interaction
Biventricular
Pacemaker

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

ClinicalTrials.gov processed this record on August 20, 2014