Pacing for Heart Failure With Preserved Ejection Fraction (HFpEF)
29 mai 2013 mis à jour par: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure.
This new pacing method may allow the heart to pump more efficiently.
Participation in this study will last approximately 8 months.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature.
When the feature is active, the device wil pace the left ventricle to target improved pump efficiency.
Patients will have the feature active for 4 months and inactive for 4 months.
The order will be randomized and the patient will not know whether the pacing is active or not.
Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.
Type d'étude
Interventionnel
Inscription (Réel)
22
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patients with quantitative ejection fraction (EF) of greater than 50 percent
- Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
- Patients greater than 18 years of age
- Patients willing and able to give informed consent
- Patients available for appropriate follow-up times for the length of study
- Patients able to complete cardiopulmonary exercise (CPX) testing
- Patients expected lifespan is greater than 12 months beyond study enrollment
- Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds
Exclusion Criteria:
- Patients who have undergone cardiac surgery 60 days prior to enrollment
- Patients who have had a myocardial infarction 90 days prior to enrollment
- Patients with hemodynamically significant uncorrected cardiac valvular disease
- Patients with active myocarditis and amyloidosis (if documented)
- Patients with a permanent pacemaker
- Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
- Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
- Patients with a PR interval greater than 250 milliseconds
- Patients with severe chronic obstructive pulmonary disease
- Patients with high risk coronary artery disease
- Patients who are or expect to become pregnant during this study
- Patients enrolled in concurrent studies which could confound the results of this study
- Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
- Patients with infiltrative disease or restrictive cardiomyopathy
- Patients with indication for percutaneous coronary intervention (PCI) at enrollment
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Fusion Pacing OFF
Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF.
At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm.
|
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Autres noms:
|
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Expérimental: Fusion Pacing ON
Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON.
At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm.
|
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of adverse events while the Fusion Pacing download is active vs. inactive.
Délai: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
Délai: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in Minnesota Living with Heart Failure Questionnaire score.
Délai: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
Délai: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
Délai: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in NT-proBNP.
Délai: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: HFpEF Trial Leader, Medtronic
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2010
Achèvement primaire (Réel)
1 janvier 2013
Achèvement de l'étude (Réel)
1 janvier 2013
Dates d'inscription aux études
Première soumission
8 janvier 2010
Première soumission répondant aux critères de contrôle qualité
8 janvier 2010
Première publication (Estimation)
11 janvier 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 mai 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mai 2013
Dernière vérification
1 mai 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MDT0095101
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