Status:
TERMINATED
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00670111
Start Date
July 1 2008
End Date
July 1 2011
Last Update
May 19 2017
Active Locations (5)
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1
Cardiovascular Associates of Northeast Arkansas
Jonesboro, Arkansas, United States, 72401
2
Cardiovascular Associates
Louisville, Kentucky, United States, 40205
3
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
4
Mayo Clinic Foundation
Rochester, Minnesota, United States, 55902