Clinical Research Unit
Clinical Trials and Registries

HEART FAILURE

CHAMPION
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients

Principal Investigator
Leonardo Clavijo, M.D., Ph.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of the CHAMPION study is to evaluate the safety and effectiveness of the HF Pressure Measurement System in reducing heart failure related hospitalizations in a subset of subjects suffering from congestive heart failure. The CardioMEMS HF Pressure Measurement System is considered an experimental device and is not yet approved by the FDA.

Enrollment Status: OPEN

HOMEOSTASIS II
Hemodynamically Guided Home Self Therapy in Severe Heart Failure Patients: Preliminary Safety and Efficacy Evaluation

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to evaluate the safety and performance of the HeartPODT System in the monitoring and treatment of heart failure symptoms. A comparison will be made between the study participant's medical status before and after the device is implanted. The HeartPOD System is considered an experimental device and is not yet approved by the FDA.

Enrollment Status: OPEN

MUSIC
Multi-Sensor Monitoring in Congestive Heart Failure Study

Principal Investigator
Jerold Shinbane, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to measure the vital signs by continuously recording the heart rate, breathing, body fluid, posture, activity and temperature using the MUSE system, an external monitor. The collected information will be used to understand what happens to the body before congestive heart failure symptoms worsen. The MUSE system is considered an experimental device and is not yet approved by the FDA.

Enrollment Status: OPEN

PEERLESS HF
Prospective Evaluation of Elastic Restraint to Lessen the Effects of Heart Failure

Principal Investigator
Jerold Shinbane, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of the PEERLESS-HF trial is to evaluate the safety and effectiveness of the HeartNet Ventricular Support System with optimal medical and device therapy (Treatment group) when compared to optimal medical and device therapy alone (Control group) as treatments for patients with heart failure. The HeartNet Ventricular Support System is a metal mesh that is designed to fit around the lower chambers of the heart and prevent it from getting any bigger. It is intended to treat patients with heart failure by providing support to the walls of the hard working lower chambers of the heart. The HeartNet Ventricular Support System is considered an experimental device and has not yet been approved by the FDA.

Enrollment Status: OPEN

RED-HF
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to assess the Efficacy and Safety of Darbopoetin alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left ventricular Systolic Dysfunction and Anemia

Principal Investigator
Uri Elkayam, M.D.

Study Coordinator
Cesar Ochoa

Study Summary
The purpose of the RED-HF study is to determine if darbepoetin alfa is safe and effective in the treatment of anemia in people with chronic heart failure.

In this study, darbepoetin alfa will be compared to a placebo. Darbepoetin alfa is approved by the FDA for the treatment of low red blood cell count in people with kidney diseases and for people receiving chemotherapy for cancer. However, it is not approved for the treatment of anemia associated with heart failure and its use in this study is considered experimental.

Enrollment Status: OPEN

SMART-AV
SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

Principal Investigator
Tasneem Naqvi, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of the SMART AV study is to compare three different ways of programming a cardiac resynchronization therapy defibrillator (CRT-D) device in heart failure patients. Patients enrolled in this study will be those whose doctor has recommended they have a CRT-D device implanted as part of their medical care. The CRT-D device is approved by the FDA for the treatment of people with advanced heart failure and altered electrical conduction within the heart. The AV delay programming methods used in this study are currently used in medical practice and not considered experimental.

Enrollment Status: OPEN