- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01169493
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial) (PACE-RBBB)
1 augusti 2016 uppdaterad av: Duke University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
16
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Durham, North Carolina, Förenta staterna, 27710
- Durham VA Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: VVI-40 to RV DDD-40 to Bi-V DDD-40
Period 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
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
Experimentell: VVI-40 to Bi-V DDD-40 to RV DDD-40
Period 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
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
Experimentell: Bi-V DDD-40 to VVI-40 to RV DDD-40
Period 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
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
Experimentell: Bi-V DDD-40 to RV DDD-40 to VVI-40
Period 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
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
Experimentell: RV DDD-40 to VVI-40 to Bi-V DDD-40
Period 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
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
Experimentell: RV DDD-40 to Bi-V DDD-40 to VVI-40
Period 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
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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.
Tidsram: 6 months
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Vänster ventrikulär ejektionsfraktion (LVEF)
Tidsram: 6 månader
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6 månader
|
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Secondary Echocardiographic Endpoints
Tidsram: 6 months
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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.
|
6 months
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Arrhythmic Events
Tidsram: 6 months
|
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.
|
6 months
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Minnesota Quality of Life Questionnaire
Tidsram: 6 months
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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.
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6 months
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6-minute Walk Distance
Tidsram: 6 months
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6-minute walk distance was the distance that a participant could walk in 6 minutes.
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6 months
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NYHA Function Class
Tidsram: 6 months
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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.
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6 months
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Left Ventricular End-diastolic Size
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Brett D Atwater, MD, Duke University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2011
Primärt slutförande (Faktisk)
1 augusti 2014
Avslutad studie (Faktisk)
1 augusti 2014
Studieregistreringsdatum
Först inskickad
22 juli 2010
Först inskickad som uppfyllde QC-kriterierna
22 juli 2010
Första postat (Uppskatta)
26 juli 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00025144
- 10CRP3630033 (Annat bidrag/finansieringsnummer: American Heart Association)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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