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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-07-31

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RAP On then Off at 1 month visit

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.

Group Type EXPERIMENTAL

Insignia Plus / Ultra (Guidant/Boston Scientific)

Intervention Type DEVICE

Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.

RAP Off then On at 1 month visit

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.

Group Type EXPERIMENTAL

Insignia Plus / Ultra (Guidant/Boston Scientific)

Intervention Type DEVICE

Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.

Interventions

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Insignia Plus / Ultra (Guidant/Boston Scientific)

Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.

Intervention Type DEVICE

Other Intervention Names

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Guidant or Boston Scientific implantable pacemakers

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No