Optimal Cardiac Resynchronization Therapy Pacing Rate

October 6, 2014 updated by: Dr. Adam Ali Ghotbi, Rigshospitalet, Denmark

Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-ischemic Heart Failure Patients: a Randomized Crossover Pilot Trial.

The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known. Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blinded randomized crossover pilot study testing two basal pacing rates: DDD-60 versus DDD-80. Each patient is paced for 2 periods of 90 days with DDD-60 and DDD-80 in a randomly sequence.

Blood samples NT-proBNP plasma levels are analysed at baseline and at the end of each phase using electrochemiluminescence-immunoassay. Patients rest for 15 minutes before the samples are taken.

These result are monitored by supervisory group to ensure that increase of more than 15% than baseline values result in termination of study.

Investigators conduct two distinct questionnaires (Minnesota Living with Heart Failure (LIfHE) questionnaire and Medical Outcome Survey Short Form (SF-36)) A symptom limiting bicycle (Ergoline, Baden-Württemberg, Germany) exercise test is performed to measure maximum work capacity and oxygen consumption at each phase.

Recordings of resting muscle sympathetic nerve activity (MSNA) are sought in all patients at both rates of pacing. All patients are studied on the same set-up in the semi-recumbent position after 30 minutes of rest. Tungsten microelectrodes (Iowa Bioengineering) are inserted into the common peroneal nerve just below the knee.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, University Hospital of Copenhagen

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:

  • Diagnosis with idiopathic dilated cardiomyopathy
  • CRT device implanted (with initial indication in accordance with European guidelines) at least 6 months prior to inclusion.
  • New York Heart Association functional (NYHA) class II-IV
  • Sinus rhythm,
  • Hemodynamically stable
  • Biventricular pacing > 90% of the time
  • On optimal medical treatment for heart failure with no changes in medications during the past 3 months.

Exclusion Criteria:

  • NYHA I
  • unable to perform exercise test (e.g. chronic obstructive pulmonary disease, severe arthritis)
  • cancer
  • plasma creatinine > 200 micromole per litre
  • an admission for decompensated HF or acute coronary syndrome in the preceding 3 months.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DDD-80 pacing
To investigate the impact of basal pacing rates of 80-bpm (DDD-80) in CRT patients on: (i) autonomic nerve function; assessed by micro-neurography, and N-terminal pro-brain natriuretic peptide (NT-proBNP) and (ii) peak oxygen consumption (pVO2) and (iii) self-perceived quality of life (QoL).
Procedure: DDD-80
Basal pacing rate set to 80-bpm. Note:Patients have already pacemaker implanted before this study.
Sham Comparator: DDD-60 pacing
To investigate the impact of basal pacing rates of 60-bpm (DDD-60) in CRT patients on: (i) autonomic nerve function; assessed by micro-neurography, and N-terminal pro-brain natriuretic peptide (NT-proBNP) and (ii) peak oxygen consumption (pVO2) self-perceived quality of life (QoL).
Procedure: DDD-60
Basal pacing rate set to 60-bpm. Note:Patients have already pacemaker implanted before this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N-terminal pro-brain natriuretic peptide
Time Frame: 3 months
Observing the change in N-terminal pro-brain natriuretic peptide in 15 patients
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic nerve function
Time Frame: 3 months
Autonomic nerve function by micro-neurography measured in bursts/min and bursts/cardiac cycle in 15 patients
3 months
Peak oxygen consumption (pVO2)
Time Frame: 3 months
pVO2 measured by a symptom limiting bicycle exercise test in 15 patients
3 months
Self-perceived quality of life
Time Frame: 3 months
Measured with the LIfHE and SF-36 questionnaires in 15 patients
3 months

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Adam A Ghotbi, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2011-034

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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