Skip to main content
OpenTrials
Completed

NCT Number: NCT02258061

Optimal Cardiac Resynchronization Therapy Pacing Rate

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Rigshospitalet, University hospital of Copenhagen

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DDD-80

Procedure

Basal pacing rate set to 80-bpm. Note:Patients have already pacemaker implanted before this study.

DDD-60

Procedure

Basal pacing rate set to 60-bpm. Note:Patients have already pacemaker implanted before this study.

Primary outcomes

  1. N-terminal pro-brain natriuretic peptide

    Time frame: 3 months

    Observing the change in N-terminal pro-brain natriuretic peptide in 15 patients

Secondary outcomes

  1. Autonomic nerve function

    Time frame: 3 months

    Autonomic nerve function by micro-neurography measured in bursts/min and bursts/cardiac cycle in 15 patients

  2. Peak oxygen consumption (pVO2)

    Time frame: 3 months

    pVO2 measured by a symptom limiting bicycle exercise test in 15 patients

  3. Self-perceived quality of life

    Time frame: 3 months

    Measured with the LIfHE and SF-36 questionnaires in 15 patients

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 7, 2014
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.