Condition category
Nervous System Diseases
Date applied
31/01/2002
Date assigned
31/01/2002
Last edited
16/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor RA Kenny

ORCID ID

Contact details

Cardiovascular Investigation Unit
Ward 15 Offices
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE14 4AH
United Kingdom
+44 (0)191 2225316
R.A.Kenny@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PG/97098

Study information

Scientific title

Acronym

Study hypothesis

To determine:
1. The prevalence of unexplained or recurrent falls in cognitively normal adult accident and emergency attendees
2. The prevalence of carotid sinus hypersensitivity in those who fall
3. Whether cardiac pacing reduces the frequency of falls in a prospective series of patients with cardioinhibitory carotid sinus hypersensitivity

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Carotid sinus syndrome

Intervention

Cardiac pacemaker versus Thera rate drop responsive Medtronic Inc dual chamber pacemaker.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Added 16/02/2009:
Number of patients who fall in the 24 months following intervention.

Secondary outcome measures

Added 16/02/2009:
1. Frequency of falls
2. Dizzy symptoms and presyncope
3. Perceived health and mental status including informant’s perception and patient’s perception
4. Injury rates
5. Use of primary, secondary and tertiary care facilities
6. Length of hospital admission
7. Change in residential circumstances
8. Cognitive function

Overall trial start date

01/10/1998

Overall trial end date

01/10/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Added 16/02/2009:
1. Aged greater than or equal to 50 years, either sex
2. A minimum of two unexplained falls, +/- up to one syncope, in the previous 12 months
3. Mini Mental State Examination (MMSE) greater than 20/30
4. Sinus rhythm
5. Greater than 3 s asystole (upright or supine) during carotid sinus massage (CSM) (i.e. cardio-inhibitory carotid sinus hypersensitivity)
6. Gait, balance, and vision, as assessed by attending physician, not attributable cause of falls

Initial information at time of registration:
Patients with a history of unexplained falls with reproducible cardio-inhibitory or mixed carotid sinus hypersensitivity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added 16/02/2009: 20 patients

Participant exclusion criteria

Added 16/02/2009:
1. Contraindication to CSM
2. Atrial fibrillation
3. Medications which enhance vagal activity
4. Neoplasm
5. Chronic renal failure
6. Chronic liver disease
7. Heart failure (New York Heart Association [NYHA] class III/IV)

Recruitment start date

01/10/1998

Recruitment end date

01/10/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiovascular Investigation Unit
Newcastle upon Tyne
NE14 4AH
United Kingdom

Sponsor information

Organisation

British Heart Foundation (UK)

Sponsor details

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk

Sponsor type

Charity

Website

http://www.bhf.org.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1999 protocol/initial results in http://www.ncbi.nlm.nih.gov/pubmed/11220545
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19124530

Publication citations

  1. Results

    Parry SW, Steen N, Bexton RS, Tynan M, Kenny RA, Pacing in elderly recurrent fallers with carotid sinus hypersensitivity: a randomised, double-blind, placebo controlled crossover trial., Heart, 2009, 95, 5, 405-409, doi: 10.1136/hrt.2008.153189.

  2. Kenny RA, SAFE PACE 2: Syncope and Falls in the Elderly--Pacing and Carotid Sinus Evaluation: a randomized controlled trial of cardiac pacing in older patients with falls and carotid sinus hypersensitivity., Europace, 1999, 1, 1, 69-72, doi: 10.1053/eupc.1998.0016.

Additional files

Editorial Notes