RESET Study

This study is closed. Thank you for your interest.

Principal Investigator Name: David Spragg, M.D.

Study Coordinator Name: Barbara Peterson, R.N., CCRC

Contact Phone: 410-955-9864

Contact: Study Coordinator Contact Phone

Contact E-mail: bpeter21@jhmi.edu

Contact: Study Coordinator Contact E-mail

Study Short Title: RESET

Study Full Title: Restoration of Chronotropic Competence in Heart Failure Patients with Normal Ejection Fraction

IRB Number: NA_00007057

Funding Source: Boston Scientific CRM

Brief Summary of Trial: Clinical trial looking at the effect of rate-adaptive pacing (RAP) in patients with heart failuire and normal ejection fraction. Potential subjects are screened for eligibility in the hospital or outpatient setting. Subjects who meet study inclusion criteria and have no exclusion criteria following a detailed record review and interview are invited to participate. After informaed consent and pre-randomization testing is completed, the subject is randomized to receive a pacemaker. All subjects randomized in the study will be followed at 1-month, 6-month, and 12 month visits. Volunteers will receive a total of $250.00 if they complete all study visits.

Inclusions: To be in this study you must meet the following qualifications: Age 18 or above Must exhibit signs and symptoms of heart failure Must have had: Prior hospitaliztion for heart failure OR Treatment for volume overload/congestion Willing and capable of providing informed conosent, undergoing a device implant and participating in all testing associated with this clinical investigation at an approved Investigational Center and at the intervals defined by this protocol. Ejection Fraction >50%

Exclusions: You cannot: Be pregnant or plan to become pregnant Be enrolled in any other study Have hypertrophic cardiomyopathy Have amyloidosis or sarcoidosis Currently have an implanted pacing/ICD lead(s) or a pacemaker/ICD pulse generator Have experienced a heart attack or unstable angina (chronic chest pain), or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to conosent, or requires either PTCA or CABG at the time of consent; Have uncontrolled diabetes

Keywords: Heart Failure Preserved Systolic Function Normal Ejection Fraction Chronotrophic Incompetence

Address for Clinical Trial Site: Johns Hopkins Hospital 600 N. Wolfe Street Baltimore, MD 21287

Compensation: Yes

Clinical Trial Start Date: Apr-08

Anticipated End Date: Apr-11