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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insignia Plus / Ultra (Guidant/Boston Scientific)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, exercise capacity, ejection fraction, Heart failure normal ejection fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Cardiovascular Associates of Northeast Arkansas
  • Cardiovascular Associates
  • Johns Hopkins Medical Institutions
  • Mayo Clinic Foundation
  • Tyler CV Consultants - Trinity Mother Frances

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RAP On then Off at 1 month visit

RAP Off then On at 1 month visit

Arm Description

Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month. Rate Adaptive Pacing (RAP) Off for second cardiopulmonary exercise test (CPX) at one month.

Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month. Rate Adaptive Pacing (RAP) On for second cardiopulmonary exercise test (CPX) at one month.

Outcomes

Primary Outcome Measures

Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.

Secondary Outcome Measures

Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.
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.

Full Information

First Posted
April 23, 2008
Last Updated
May 17, 2017
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00670111
Brief Title
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
Acronym
RESET
Official Title
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in enrollment
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 the effect of pacing on exercise capacity and quality of life in this heart failure population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, exercise capacity, ejection fraction, Heart failure normal ejection fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAP On then Off at 1 month visit
Arm Type
Experimental
Arm Description
Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month. Rate Adaptive Pacing (RAP) Off for second cardiopulmonary exercise test (CPX) at one month.
Arm Title
RAP Off then On at 1 month visit
Arm Type
Experimental
Arm Description
Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month. Rate Adaptive Pacing (RAP) On for second cardiopulmonary exercise test (CPX) at one month.
Intervention Type
Device
Intervention Name(s)
Insignia Plus / Ultra (Guidant/Boston Scientific)
Other Intervention Name(s)
Guidant or Boston Scientific implantable pacemakers
Intervention Description
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
Primary Outcome Measure Information:
Title
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
Description
Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.
Time Frame
1 month post implant
Secondary Outcome Measure Information:
Title
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.
Description
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.
Time Frame
6 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Kass, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Associates of Northeast Arkansas
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Cardiovascular Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Mayo Clinic Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Tyler CV Consultants - Trinity Mother Frances
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20123314
Citation
Kass DA, Kitzman DW, Alvarez GE. The restoration of chronotropic competence in heart failure patients with normal ejection fraction (RESET) study: rationale and design. J Card Fail. 2010 Jan;16(1):17-24. doi: 10.1016/j.cardfail.2009.08.008. Epub 2009 Oct 7.
Results Reference
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Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction

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