Heart Failure Clinical Trial

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

Summary

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

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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.

View Eligibility Criteria

Eligibility Criteria

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)

Study is for people with:

Heart Failure

Estimated Enrollment:

32

Study ID:

NCT00670111

Recruitment Status:

Terminated

Sponsor:

Boston Scientific Corporation

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There are 5 Locations for this study

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Cardiovascular Associates of Northeast Arkansas
Jonesboro Arkansas, 72401, United States
Cardiovascular Associates
Louisville Kentucky, 40205, United States
Johns Hopkins Medical Institutions
Baltimore Maryland, 21205, United States
Mayo Clinic Foundation
Rochester Minnesota, 55902, United States
Tyler CV Consultants - Trinity Mother Frances
Tyler Texas, 75701, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

32

Study ID:

NCT00670111

Recruitment Status:

Terminated

Sponsor:


Boston Scientific Corporation

How clear is this clinincal trial information?

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