Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction

Not Applicable

Terminated

Brief Summary: This study will look at how pacing your heart may assist your daily activities and how you are feeling.

Detailed Description: RESET is a multicenter trial that will assess the effect of pacing in heart failure patients with a normal ejection fraction (or diastolic heart failure). The purpose of the RESET study is to evaluate the effect of pacing on exercise capacity and quality of life in this heart failure population.

Recruitment & Eligibility

Inclusion Criteria

Patients who are in sinus rhythm
Patients who are on stable medical therapy
Patients who exhibit signs and symptoms of heart failure, New York Heart Association (NYHA) Class II or III
Patients who have experienced a hospitalization for decompensated heart failure; treatment for pulmonary congestion or volume overload; chronic treatment with a loop diuretic; or a brain natriuretic peptide (BNP) > 125 ng/l.
Left ventricular ejection fraction (LVEF) ≥ 50%

Exclusion Criteria

Patients with persistent atrial fibrillation or atrial flutter
Patients who are in complete heart block
Patients who have experienced a recent myocardial infarction (MI) or have unstable angina or require cardiac surgery or other procedures
Patients who have severe heart valve disease or valve replacement
Patients with a contraindication for a pacemaker system
Patients who have a neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercise testing
Patients who have infiltrative or hypertrophic cardiomyopathy
Patients who have known severe pulmonary disease
Patients with uncontrolled diabetes or blood pressure (systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 95 mmHg)

Arm && Interventions

Group	Intervention	Description
RAP Off then On at 1 month visit	Insignia Plus / Ultra (Guidant/Boston Scientific)	1. Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month. 2. Rate Adaptive Pacing (RAP) On for second cardiopulmonary exercise test (CPX) at one month.
RAP On then Off at 1 month visit	Insignia Plus / Ultra (Guidant/Boston Scientific)	1. Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month. 2. Rate Adaptive Pacing (RAP) Off for second cardiopulmonary exercise test (CPX) at one month.

Primary Outcome Measures

Name	Time	Method
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.	1 month post implant	Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.

Secondary Outcome Measures

Name	Time	Method
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.	6 months post implant	Each patient had RAP therapy On from one through six months. This endpoint evaluated Peak VO2 measured at 6 months (RAP On) vs. Peak VO2 measured at 1 month without RAP therapy (RAP Off).All participants were "RAP On" for months 1 through 6. All participants were 'Rap On' for months 6 to 12.

Locations (5): Cardiovascular Associates
🇺🇸
Louisville, Kentucky, United States
Cardiovascular Associates of Northeast Arkansas
🇺🇸
Jonesboro, Arkansas, United States
Johns Hopkins Medical Institutions
🇺🇸
Baltimore, Maryland, United States
Mayo Clinic Foundation
🇺🇸
Rochester, Minnesota, United States
Tyler CV Consultants - Trinity Mother Frances
🇺🇸
Tyler, Texas, United States