Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction (RESET)
May 17, 2017 updated by: Boston Scientific Corporation
This study will look at how pacing your heart may assist your daily activities and how you are feeling.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 the effect of pacing on exercise capacity and quality of life in this heart failure population.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Jonesboro, Arkansas, United States, 72401
- Cardiovascular Associates of Northeast Arkansas
-
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Kentucky
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Louisville, Kentucky, United States, 40205
- Cardiovascular Associates
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Medical Institutions
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic Foundation
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Texas
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Tyler, Texas, United States, 75701
- Tyler CV Consultants - Trinity Mother Frances
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RAP On then Off at 1 month visit
|
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
Other Names:
|
|
Experimental: RAP Off then On at 1 month visit
|
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
Other Names:
|
What is the study measuring?
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.
Time Frame: 1 month post implant
|
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.
Time Frame: 6 months post implant
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David A Kass, M.D., Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
April 23, 2008
First Submitted That Met QC Criteria
April 29, 2008
First Posted (Estimate)
May 1, 2008
Study Record Updates
Last Update Posted (Actual)
May 19, 2017
Last Update Submitted That Met QC Criteria
May 17, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESET (Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.