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

Boston Scientific

Status: Terminated

Conditions: Heart Failure

Treatments: Device: Insignia Plus / Ultra (Guidant/Boston Scientific)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670111

RESET

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

RAP On then Off at 1 month visit

Experimental group

Description:

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.

Treatment:

Device: Insignia Plus / Ultra (Guidant/Boston Scientific)

RAP Off then On at 1 month visit

Experimental group

Description:

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.

Treatment:

Device: Insignia Plus / Ultra (Guidant/Boston Scientific)