Optimal Cardiac Resynchronization Therapy Pacing Rate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cardiac Resynchronization Therapy Heart Failure Bi-ventricular Pacing Sympathetic Activity Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

DDD-80

Intervention Type PROCEDURE

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

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).

Group Type SHAM_COMPARATOR

DDD-60

Intervention Type PROCEDURE

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

Interventions

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DDD-80

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

Intervention Type PROCEDURE

DDD-60

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No