Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction (RESET)
This study has been terminated.
(Difficulty in enrollment)
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00670111
First received: April 23, 2008
Last updated: August 8, 2011
Last verified: August 2011
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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
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 Medical Institutions |
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 June 18, 2013