Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy

July 15, 2019 updated by: Hull University Teaching Hospitals NHS Trust

A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy

Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. Approximately one third of patients treated with CRT do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssynchrony).

The investigators propose a new method to achieve atrioventricular synchrony in CRT based on measurements of electrical conduction from within the heart. Patients referred for CRT implantation at Castle Hill Hospital are eligible to participate. During CRT implantation, additional measurements, will be recorded from within the heart. After implantation, device settings will be adjusted to either standard or electrophysiologically-optimised settings with cross-over at 4 months.

The investigators hypothesis is that patients with optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of heart failure
  • Referred for cardiac resynchronisation therapy (CRT) with or without defibrillator
  • In sinus rhythm
  • Patients must have a telephone
  • Ability to give informed consent
  • Ability to complete the study

Exclusion Criteria:

  • Severe valve disease or previous valve replacement
  • Previous atrial flutter ablation
  • Chronic kidney disease Stage 3 or above
  • Recent myocardial infarction
  • Ongoing cardiac ischaemia
  • Infiltrative cardiomyopathy
  • Wolff-Parkinson White syndrome
  • Presence of second or third degree heart block
  • <90% biventricular pacing at 3 months
  • Hypertrophic cardiomyopathy
  • Pregnancy or breastfeeding
  • On treatment for hypothyroidism or hyperthyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: His-Ventricular (HV)-optimised
His-Ventricular (HV) optimised atrioventricular delay
Other: His-Ventricular (HV) optimisation
Optimisation of atrioventricular pacing interval
NO_INTERVENTION: Non-optimised
Standard atrioventricular delay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time Frame: 7 months and 11 months
7 months and 11 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in 6-min walk test distance by ≥25 m
Time Frame: 7 months and 11 months
7 months and 11 months
≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score
Time Frame: 7 months and 11 months
7 months and 11 months
Reduction of left ventricular end-diastolic volume.
Time Frame: 7 months and 11 months
7 months and 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 29, 2016

Primary Completion (ACTUAL)

April 28, 2017

Study Completion (ACTUAL)

March 15, 2018

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (ESTIMATE)

April 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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