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British Randomised Controlled Trial of Atrioventricular (AV) and Interventricular (VV) Optimisation (BRAVO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Aberdeen
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01258829
First received: December 10, 2010
Last updated: June 17, 2014
Last verified: May 2014
  Purpose

Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for heart failure do not have the settings of their device optimised. The most widely available method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to determine the optimal settings. However, this is not frequently performed because it is time consuming and requires two skilled operators. In this study the investigators will test a new non-invasive method for optimisation, which utilises pressure measurements (non-invasive blood pressure measured from the finger).

Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation.


Condition Intervention
Heart Failure
Other: Non-invasive haemodynamic optimisation
Other: ECHO optimisation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: British Randomised Controlled Trial of AV and VV Optimisation (BRAVO): Randomised Clinical Trial of the Effects of Non-invasive Haemodynamic Optimisation of Cardiac Resynchronisation Devices on Exercise Capacity

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation [ Time Frame: 6 months following the last follow-up of the last patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether pressure optimisation is at least equivalent to echo optimisation of flow: in terms resulting size of the heart in terms of quality of life scores in terms of blood marker of heart failure severity [ Time Frame: 6 months following the last follow-up of the last patient ] [ Designated as safety issue: No ]

Enrollment: 403
Study Start Date: December 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-invasive haemodynamic optimisation
Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation
Other: Non-invasive haemodynamic optimisation
Comparing the method of non-invasive haemodynamic
Active Comparator: ECHO optimisation
Optimization of AV/VV delay using the guideline recommendations
Other: ECHO optimisation
Standard ECHO optimisation method

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic heart failure due to systolic dysfunction
  • Biventricular pacemaker implanted
  • Give written informed consent

Exclusion Criteria:

  • Lung disease or any condition that would preclude them from walking on a treadmill
  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: NCT01258829

Locations
United Kingdom
ICCH, Imperial College London
London, United Kingdom
Sponsors and Collaborators
Imperial College London
University of Aberdeen
Investigators
Principal Investigator: Dr Darrel Francis Imperial College London
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01258829     History of Changes
Other Study ID Numbers: 10/H0803/86
Study First Received: December 10, 2010
Last Updated: June 17, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Heart Failure Cardiac Resynchronisation Therapy

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014