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

Heart Failure Clinical Trial

— RESET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00670111
• Other study ID #: RESET
• Status: Terminated
• Phase: N/A
• First received: April 23, 2008
• Last updated: May 17, 2017
• Start date: July 2008
• Est. completion date: July 2011

Study information

• Verified date: May 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at how pacing your heart may assist your daily activities and how you are feeling.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland
United States	Cardiovascular Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Cardiovascular Associates	Louisville	Kentucky
United States	Mayo Clinic Foundation	Rochester	Minnesota
United States	Tyler CV Consultants - Trinity Mother Frances	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month post implant
Secondary	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.	6 months post implant