Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

Heart Failure, Systolic Clinical Trial

— PPPR  

Official title:

Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627585
• Other study ID #: ICA-CDRF-2016-02-055
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 6, 2019

Study information

• Verified date: September 2019
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.

This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

Description:

Patients (n=70) with long-term (>2 years) permanent pacemakers with avoidable RV pacing will be invited to participate in a single-centre, phase II, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. Those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. All participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (EQ-5D-5L), blood tests and pacemaker check.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 6, 2019
• Est. primary completion date: January 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic right ventricular bradycardia pacemaker implanted for at least 24 months

• Willing and able to give informed consent for the intervention

Exclusion Criteria:

• Known poor imaging quality patients (details of patients excluded for this reason will be recorded)

• Patients with complete heart block and no reprogramming options

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Left Ventricular Dysfunction
• Left Ventricular Failure
• Pacemaker; Complication, Mechanical
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Personalised programming
Reprogramming protocol already test in an observation cohort will be utilised which will direct physiologists to consider pacemaker mode, base rate, utilisation of rate response, hysteresis, sleep and rest rates as well as lead outputs.

Locations

Country	Name	City	State
United Kingdom	Harrogate District Foundation Trust	Harrogate
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction	Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.	6 months
Secondary	LV remodelling parameters	left ventricular end diastolic and systolic volumes	6 months
Secondary	Quality of Life Measures	EQ-5D, Minnesota living with Heart Failure Questionnaire	6 months
Secondary	Battery Longevity	Impedance	6 months