Pacing for Heart Failure With Preserved Ejection Fraction

Heart Failure Clinical Trial

— HFpEF  

Official title:

Pacing for Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045291
• Other study ID #: MDT0095101
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: May 29, 2013
• Start date: June 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

Belgium,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events while the Fusion Pacing download is active vs. inactive.		From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit	No
Primary	Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.		From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit	No
Secondary	Change in Minnesota Living with Heart Failure Questionnaire score.		From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit	No
Secondary	Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).		From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit	No
Secondary	Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.		From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit	No
Secondary	Change in NT-proBNP.		From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit	No