Clinical Trial: Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)

Brief Summary: This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.

Detailed Summary: This pilot clinical trial will be a randomized single blinded cross over trial. Each subject will undergo three study stages. Subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. In the second stage, both arms transition to a two months, intervention free, wash out period. Finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.
Sponsor: Michael C. Giudici

Current Primary Outcome: Positive reverse left ventricular remodeling, defined as increase in LV Ejection Fraction >15% [ Time Frame: 3 months ]

Original Primary Outcome: Positive reverse left ventricular remodeling, defined as increase in LV Ejection Fraction >15% [ Time Frame: 6 months ]

Current Secondary Outcome:

  • Electrocardiographic: QRS duration [ Time Frame: 3 months ]
  • Echocardiographic: LV end-systolic and diastolic diameters and volumes [ Time Frame: 3 months ]
  • Echocardiographic: RV size and function [ Time Frame: 3 months ]
  • Echocardiographic: severity of mitral and tricuspid valve regurgitation [ Time Frame: 3 months ]
  • Echocardiographic: estimated pulmonary artery systolic pressure [ Time Frame: 3 months ]
  • Echocardiographic: Inter-ventricular conduction delay [ Time Frame: 3 months ]
  • Heart failure symptoms (NYHA functional class). [ Time Frame: 3 months ]
  • Walking distance (6 minute walk test) [ Time Frame: 3 months ]
  • Quality of life (Minnesota living with heart failure questionnaire) [ Time Frame: 3 months ]
  • Laboratory: Plasma NT-proBNP [ Time Frame: 3 months ]
  • Laboratory: Plasma Sodium [ Time Frame: 3 months ]
  • Laboratory: Plasma BUN and Creatinine [ Time Frame: 3 months ]
  • Ventricular arrhythmia burden. An episode is defined as ventricular tachycardia or fibrillation that requires anti-tachycardia pacing therapy, defibrillation or lasts >30 seconds [ Time Frame: 3 months ]


Original Secondary Outcome:

  • Electrocardiographic: QRS duration [ Time Frame: 6 months ]
  • Echocardiographic: LV end-systolic and diastolic diameters and volumes [ Time Frame: 6 months ]
  • Echocardiographic: RV size and function [ Time Frame: 6 months ]
  • Echocardiographic: severity of mitral and tricuspid valve regurgitation [ Time Frame: 6 months ]
  • Echocardiographic: estimated pulmonary artery systolic pressure [ Time Frame: 6 months ]
  • Echocardiographic: Inter-ventricular conduction delay [ Time Frame: 6 months ]
  • Heart failure symptoms (NYHA functional class). [ Time Frame: 6 months ]
  • Walking distance (6 minute walk test) [ Time Frame: 6 months ]
  • Quality of life (Minnesota living with heart failure questionnaire) [ Time Frame: 6 months ]
  • Laboratory: Plasma NT-proBNP [ Time Frame: 6 months ]
  • Laboratory: Plasma Sodium [ Time Frame: 6 months ]
  • Laboratory: Plasma BUN and Creatinine [ Time Frame: 6 months ]
  • Ventricular arrhythmia burden. An episode is defined as ventricular tachycardia or fibrillation that requires anti-tachycardia pacing therapy, defibrillation or lasts >30 seconds [ Time Frame: 6 months ]


Information By: University of Iowa

Dates:
Date Received: May 6, 2015
Date Started: August 2015
Date Completion: June 2018
Last Updated: March 30, 2017
Last Verified: March 2017