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

This study has been terminated.
(Difficulty in enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670111
First Posted: May 1, 2008
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
This study will look at how pacing your heart may assist your daily activities and how you are feeling.

Condition Intervention
Heart Failure Device: Insignia Plus / Ultra (Guidant/Boston Scientific)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

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. [ 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.


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. [ 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.


Enrollment: 32
Study Start Date: July 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAP On then Off at 1 month visit
  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.
Device: Insignia Plus / Ultra (Guidant/Boston Scientific)
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
Other Name: Guidant or Boston Scientific implantable pacemakers
Experimental: RAP Off then On at 1 month visit
  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.
Device: Insignia Plus / Ultra (Guidant/Boston Scientific)
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
Other Name: Guidant or Boston Scientific implantable pacemakers

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670111


Locations
United States, Arkansas
Cardiovascular Associates of Northeast Arkansas
Jonesboro, Arkansas, United States, 72401
United States, Kentucky
Cardiovascular Associates
Louisville, Kentucky, United States, 40205
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
United States, Minnesota
Mayo Clinic Foundation
Rochester, Minnesota, United States, 55902
United States, Texas
Tyler CV Consultants - Trinity Mother Frances
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: David A Kass, M.D. Johns Hopkins University
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00670111     History of Changes
Other Study ID Numbers: RESET
First Submitted: April 23, 2008
First Posted: May 1, 2008
Results First Submitted: May 3, 2012
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
Heart failure
exercise capacity
ejection fraction
Heart failure normal ejection fraction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases