Heart Failure 

Heart Failure (Cardiomyopathy) Research

Heart failure occurs when the heart muscle is damaged and cannot pump enough blood to meet the needs of the body. Heart failure can result from damage due to heart attack, blocked or narrowed arteries, high blood pressure, valve disease or other diseases.

The goal of OSU Medical Center heart failure research is to determine the best ways to improve the heart’s ability to pump blood so that the patient can resume a more normal lifestyle.

For information about OSU Medical Center heart research, call (614) 292-1616 between 8:30 a.m. and 4:30 p.m. weekdays.

OSU Medical Center Clinical Trials

Investigational Pacemaker for Heart Failure
Exercise and Heart Failure

Research Topic: Investigational Pacemaker for Heart Failure
Trial Name: Evaluation of the Safety and Efficacy of the OPTIMIZER II System with Active Fixation Leads in Subjects with Heart Failure Resulting from Systolic Dysfunction (FIX-HF-5)

Trial Description: FIX-HF-5 is a 12-month, multi-center, randomized, double-blind trial evaluating the impact of the OPTIMIZER II System on the cardiac function, quality of life, and activity/exercise tolerance of people diagnosed with moderate to severe heart failure. The OPTIMIZER II System involves an investigational device capable of delivering electrical signals (non-excitatory cardiac contractility modulation) to the heart in order to improve cardiac functioning.

All participants in the trial are implanted with the OPTIMIZER II device and are randomized to either a device activation group (device is turned on) or a device non-activation (Sham) group.

Trial Eligibility:
Women and men at least 18 years old
Heart failure diagnosis
Peak oxygen consumption between 11 and 19 ml 02/min/kg
LVEF <35%
NYHA Class III or IV heart failure
Receiving optimal heart failure medical therapy for previous 90 days
Participants may have an implanted pacemaker or ICD system but not a Bi-V device

Trial Sponsor: (OSU Principal Investigator)
Impulse Dynamics (USA), Inc. (Charles Love, MD)

Contact For Additional Trial Information
Research Coordinator: Yousef Khan, MBBS, MPH
Phone: 247-7732; Pager: 346-5286
E-mail: Yosef.khan@osumc.edu

WIRB Approval #1776581.0

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Research Topic: Exercise and Heart Failure
Trial Name: Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION)

Trial Description: HF-ACTION is a 5-year, 3,000-patient, multi-center randomized trial testing the long-term impact of exercise training on heart-related physical symptoms and the number/type of hospitalizations in people diagnosed with congestive heart failure (CHF).

Participants are randomized to receive either exercise training in addition to usual medical care or usual medical care alone.

Trial Eligibility:
Women and men at least 18 years of age
Heart failure diagnosis
NYHA HF class II, III, or IV for the previous 3 months
LVEF < 35%
Receiving optimal heart failure medical therapy for at least 6 weeks
Not exercising regularly but medically able to begin exercise program
No heart-related procedure or hospitalization within past 6 weeks

Trial Sponsor: (OSU Principal Investigator)
National Heart, Lung, and Blood Institute; National Institutes of Health (William Abraham, MD)

Contact For Additional Trial Information
Research Coordinator: Danuta Biniakiewicz, PhD
Phone: (614) 292-5462; E-mail: biniakiewicz-1@medctr.osu.edu
Research Pager: (614) 346-0226

OSUIRB Approval 10/18/04

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