Optimised Pacing Program

NCT01819662 | Unknown Phase 3 DMC

• 1 other identifier: NIHR-CS-012-032
• Study Type: interventional
• Target: 1,793
• Locations: 1 country
• Sites: 3

Brief Summary

Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people have a pacemaker, and each year another 36,000 receive them. All of these patients are usually seen yearly to have their device checked. However, pacemaker technology is now very reliable, batteries last well over 5 years, and many patients require their pacemaker only occasionally as a back-up. Each visit costs around £200 such that pacemaker follow-up cost the NHS around £50million per year. Most visits involve checking the battery and the leads which, in the absence of symptoms might be unnecessary. Pacemaker patients are at risk of developing other problems including heart failure which puts them at higher risk of hospitalisation and death. For those under follow-up, no mechanism exists to identify whether they might have heart failure, and for those receiving new implants, it is unclear which will go on to develop heart failure. Also, whether optimal heart failure treatment with a multidisciplinary team reduces the chances that they will be hospitalised is also unproven. Our study therefore has three main aims: 1) based on pacing indications and patient factors, to identify which patients are likely to develop complications and therefore which patients could be seen less frequently; 2) to validate and refine a simple risk score to help identify which patients in pacing clinic should undergo screening for heart failure; and 3) to establish whether such screening and subsequent optimisation of those with heart failure is clinically and cost-effective for reducing hospitalisation and death.

Conditions

Pacemaker Complication; Congestive Heart Failure

Keywords

Pacemaker, heart failure, hospitalisation

Outcome Measures

Primary Outcomes (1)

• Combined hospitalisation and mortality

  3 years

Secondary Outcomes (1)

• Predictors of complications from pacemaker implantation

  3 years

Other Outcomes (1)

• Predictors of cardiac dysfunction in pacemaker patients

  1-3 years

Study Arms (3)

Standard management

PLACEBO COMPARATOR

No echocardiogram

Other: Standard management

Enhanced standard management

ACTIVE COMPARATOR

Echocardiogram performed, with results to GP

Other: Enhanced standard management

Optimised heart failure management

ACTIVE COMPARATOR

Echocardiogram, followed by referral to comprehensive heart failure program for those with left ventricular dysfunction

Other: Optimised heart failure management

Interventions

Enhanced standard management OTHER

Echocardiogram followed by letter to GP about results.

Enhanced standard management

Optimised heart failure management OTHER

Echocardiogram followed by referral to comprehensive heart failure service for those with left ventricular dysfunction

Optimised heart failure management

Standard management OTHER

Usual care

Standard management

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pacemaker implantation

You may not qualify if:

• Dementia, unwilling to fill in quality of life questionnaires, unwilling to sign consent form

Sponsors & Collaborators

• University of Leeds: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (3)

Bradford Hospitals NHS Foundation Trust

Bradford, Yorkshire, United Kingdom

Location

Harrogate Hospital Foundation Trust

Harrogate, Yorkshire, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Related Publications (2)

• Paton MF, Gierula J, Jamil HA, Straw S, Lowry JE, Byrom R, Slater TA, Fellows AM, Gillott RG, Chumun H, Smith P, Cubbon RM, Stocken DD, Kearney MT, Witte KK. Echocardiographic screening for heart failure and optimization of the care pathway for individuals with pacemakers: a randomized controlled trial. Nat Med. 2024 Nov;30(11):3303-3309. doi: 10.1038/s41591-024-03265-3. Epub 2024 Sep 19.

  PMID: 39300290 DERIVED

• Paton MF, Gierula J, Jamil HA, Lowry JE, Byrom R, Gillott RG, Chumun H, Cubbon RM, Cairns DA, Stocken DD, Kearney MT, Witte KK. Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial. BMJ Open. 2019 Jul 17;9(7):e028613. doi: 10.1136/bmjopen-2018-028613.

  PMID: 31320354 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Klaus K Witte, MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 24, 2013
• First Posted: March 27, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: February 28, 2019
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

GB (3)