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

This study has been terminated.
(Difficulty in enrollment)
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00670111
First received: April 23, 2008
Last updated: August 8, 2011
Last verified: August 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 VO2 [ Time Frame: 1 month, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
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: 1
Two experimental and/or intervention groups under 1 arm.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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, 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 BNP > 125 ng/l.
  • Left ventricular ejection fraction ≥ 50%

Exclusion Criteria:

  • Patients with persistent atrial fibrillation or atrial flutter
  • Patients who are in complete heart block
  • Patients who have experienced a recent 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 (SBP > 160 mmHg or DBP > 95 mmHg)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Douglas Daum Ph.D. / Director, Therapy Research, Boston Scientific Cardiac Rhythm Management
ClinicalTrials.gov Identifier: NCT00670111     History of Changes
Other Study ID Numbers: RESET
Study First Received: April 23, 2008
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014