Clinical trial NCT00670111: Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
Official title: Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
exercise capacity
ejection fraction
Heart failure normal ejection fraction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
timeFrame: 1 month post implant
Secondary outcomes:
measure: Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.
timeFrame: 6 months post implant
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Cardiovascular Associates of Northeast Arkansas
state: Arkansas
city: Louisville
country: United States
facility: Cardiovascular Associates
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Foundation
state: Minnesota
city: Tyler
country: United States
facility: Tyler CV Consultants - Trinity Mother Frances
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: David A Kass, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.