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Heart FailurePACE-RBBBNCT01169493

Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)

A study testing VVI-40, RV DDD-40 and BiV DDD-40 in people with Heart Failure and Right Bundle-Branch Block, run by Duke University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis. Approximately half of all HF patients have electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a perturbation of the normal pattern of ventricular… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Right Bundle-Branch Block
What is being tested?
VVI-40, RV DDD-40 and BiV DDD-40
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesUnited States
Study dates
Jan 2011to Aug 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cardiomyopathy of either idiopathic or ischemic etiology
  • NYHA class III, or IV symptoms
  • Sinus rhythm
  • QRS complex duration > 130 msec in ≥ 2 surface ECG leads with RBBB
  • PR interval > 150 msec and < 240 msec
  • Prior implantation of dual chamber BiV ICD with apical RV lead location

Who cannot join

  • Myocardial infarction, major surgical procedure, or acute cardiac failure crisis requiring inotropes within 6 months of entry into the study
  • Atrial fibrillation or flutter lasting >12 hours within the last 6 months
  • Sick sinus syndrome, complete heart block, or other arrhythmias requiring pacemaker support
  • Pregnancy
  • Any other known condition other than heart failure that could limit exercise time or survival to < 6 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Durham VA Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis. Approximately half of all HF patients have electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a perturbation of the normal pattern of ventricular contraction that reduces the efficiency of ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF symptomatology in this subset of patients. Resynchronization of ventricular contraction is usually achieved through simultaneous pacing of the left and right ventricles using a biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial evidence supporting the use of BiV pacing in patients with prolonged QRS duration was obtained almost exclusively in patients with a left bundle-branch block (LBBB) electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular contraction in patients with LBBB can be obtained by univentricular left ventricular pacing with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that ventricular resynchronization can be obtained in subjects with right bundle-branch block (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac death. Most of these devices are currently programmed to avoid RV pacing. We aim to determine if ventricular resynchronization delivered through univentricular RV pacing improves symptoms in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD implantation for symptomatic heart failure. We further aim to determine if ventricular resynchronization improves myocardial performance and ventricular geometry as detected by echocardiographic measures and quality of life for patients with HF and RBBB. We hypothesize that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF symptoms, and positive ventricular remodeling in patients with HF and RBBB.

Being tested
VVI-40, RV DDD-40, BiV DDD-40
Keywords
Heart Failure, Right Bundle-Branch Block, Cardiac Resynchronization Therapy
Medical subject headings
Heart Failure, Bundle-Branch Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VVI-40Device

    Pacing mode set to VVI-40, RV only pacing

  • RV DDD-40Device

    ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

  • BiV DDD-40Device

    ICD programmed to BiV pacing at a lower rate of 40

Study groups in NCT01169493
Study groupRoleWhat they receive
VVI-40 to RV DDD-40 to Bi-V DDD-40ExperimentalPeriod 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
Receives: Device: VVI-40; Device: RV DDD-40; Device: BiV DDD-40
VVI-40 to Bi-V DDD-40 to RV DDD-40ExperimentalPeriod 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
Receives: Device: VVI-40; Device: RV DDD-40; Device: BiV DDD-40
Bi-V DDD-40 to VVI-40 to RV DDD-40ExperimentalPeriod 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
Receives: Device: VVI-40; Device: RV DDD-40; Device: BiV DDD-40
Bi-V DDD-40 to RV DDD-40 to VVI-40ExperimentalPeriod 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
Receives: Device: VVI-40; Device: RV DDD-40; Device: BiV DDD-40
RV DDD-40 to VVI-40 to Bi-V DDD-40ExperimentalPeriod 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
Receives: Device: VVI-40; Device: RV DDD-40; Device: BiV DDD-40
RV DDD-40 to Bi-V DDD-40 to VVI-40ExperimentalPeriod 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
Receives: Device: VVI-40; Device: RV DDD-40; Device: BiV DDD-40

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.

    Measured: 6 months

Secondary outcomes (7)

  1. Secondary Echocardiographic Endpoints

    Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.

    Measured: 6 months

  2. Arrhythmic Events

    To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.

    Measured: 6 months

  3. Minnesota Quality of Life Questionnaire

    This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.

    Measured: 6 months

  4. 6-minute Walk Distance

    6-minute walk distance was the distance that a participant could walk in 6 minutes.

    Measured: 6 months

  5. NYHA Function Class

    The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.

    Measured: 6 months

  6. Left Ventricular Ejection Fraction (LVEF)

    Measured: 6 months

  7. Left Ventricular End-diastolic Size

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionAug 2014
  4. Study completionAug 2014

Why it stopped: Lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01169493
Sponsor's protocol ID
Pro00025144
Other IDs
10CRP3630033
Acronym
PACE-RBBB
Status last verified
Aug 2016
First submitted
22 Jul 2010
Last updated
23 Sep 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing VVI-40, RV DDD-40 and BiV DDD-40 in people with Heart Failure and Right Bundle-Branch Block, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01169493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.

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