Optimising Pacemaker Therapy for Contractility

NCT02964650 | Completed Phase 2

• 1 other identifier: IRAS 218963
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled trial whether optimal programming versus standard rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity. 60 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test and fill out a quality of life questionnaire. They will then be randomised to optimal rate-response settings or standard rate response settings and followed up at 6 months at which point the tests will be repeated.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Treadmill walk time

  Time walked during a standard incremental treadmill test

  6 months

Secondary Outcomes (3)

• Quality of life

  6 months

• Left ventricular function by echocardiography

  6 months

• Battery longevity

  6 months

Study Arms (2)

Standard rate-response settings

NO INTERVENTION

Patients allocated to standard rate-response settings.

Personalised rate-response settings

EXPERIMENTAL

Patients allocated to optimised rate-response settings.

Device: Personalised rate-response settings

Interventions

Personalised rate-response settings DEVICE

Rate response range fixed to limits suggested by force-frequency curve

Personalised rate-response settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic CHF due to left ventricular systolic dysfunction (LVEF\<45%),
• Cardiac pacemaker,
• Able to perform a peak exercise test,
• Willing and able to give informed consent.

You may not qualify if:

• Angina pectoris symptoms limiting exercise tolerance,
• Unstable heart failure symptoms (medical therapy changes in last three months), Poor image quality,
• Calcium channel blockers (CCBs).

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds General Infirmary

Leeds, United Kingdom

Location

Related Publications (1)

• Gierula J, Lowry JE, Paton MF, Cole CA, Byrom R, Koshy AO, Chumun H, Kearney LC, Straw S, Bowen TS, Cubbon RM, Keenan AM, Stocken DD, Kearney MT, Witte KK. Personalized Rate-Response Programming Improves Exercise Tolerance After 6 Months in People With Cardiac Implantable Electronic Devices and Heart Failure: A Phase II Study. Circulation. 2020 May 26;141(21):1693-1703. doi: 10.1161/CIRCULATIONAHA.119.045066. Epub 2020 Apr 17.

  PMID: 32299222 DERIVED

Study Officials

• Klaus Witte, MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Cardiology

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 16, 2016
• Study Start: June 20, 2017
• Primary Completion: September 30, 2019
• Study Completion: October 31, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

GB (1)