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

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

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Insignia Plus / Ultra (Guidant/Boston Scientific)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAP On then Off at 1 month visit<br>Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month. Rate Adaptive Pacing (RAP) Off for second cardiopulmonary exercise test (CPX) at one month. | Device: Insignia Plus / Ultra (Guidant/Boston Scientific)<br>* Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.<br>* Other names: Guidant or Boston Scientific implantable pacemakers;|
| Experimental: RAP Off then On at 1 month visit<br>Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month. Rate Adaptive Pacing (RAP) On for second cardiopulmonary exercise test (CPX) at one month. | Device: Insignia Plus / Ultra (Guidant/Boston Scientific)<br>* Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.<br>* Other names: Guidant or Boston Scientific implantable pacemakers;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month. | 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. | 6 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, exercise capacity, ejection fraction, Heart failure normal ejection fraction