Cardiovascular Research Unit
Clinical Trials and Registries

HEART FAILURE

LAPTOP-HF
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to collect information on a new way to evaluate and manage heart failure (HF). Currently doctors use symptoms like shortness of breath, reduced exercise capacity, swelling of the ankles, fatigue and weakness to evaluate heart failure and to help decide the best doses of medications. Often, by the time symptoms occur, a person might need to be hospitalized to control the heart failure.

This study will collect information on the Left Atrial Pressure (LAP) Monitoring Systems. Two types of study devices are being used for this study. One is called the HeartPOD® System. The other is called the LAP Combo System. In this consent form, these systems will be referred to as the “study devices”. We want to see if they can be safely and effectively used in people who have HF. Both the HeartPOD System and the LAP Combo System are experimental, which means that they have not been approved by the Food and Drug Administration (FDA).

Both of these study devices are surgically implanted. They are able to take readings of the blood pressure within the heart. This information may help us to see if medication changes are needed before symptoms occur or before a person needs to be hospitalized. We hope to learn whether people who have one of the study devices have fewer hospitalizations for heart failure than people who do not have a study device.

Enrollment Status: OPEN

RED-HF
A Double-Blind, Randomized, Placebo-Controlled, MultiCenter Study to Assess the Efficacy and Safety of Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia

Principal Investigator
Uri Elkayam, M.D.

Study Coordinator
Cesar Ochoa

Study Summary
This study is testing a new kind of erythropoietin (protein that stimulates the production of red blood cells). This new protein is called darbepoetin alfa (Aranesp®). We hope to learn if darbepoetin alfa is safe and effective in the treatment of low red blood cell counts (anemia in people with chronic heart failure. This study will evaluate if the study drug lowers the risk of hospital admission or death due to worsening heart failure. This study will also measure whether the study drug affects the general well-being of people with heart failure.

Darbepoetin alfa is approved by the Food and Drug Administration (FDA) for the treatment of low red blood cell count in people with kidney diseases and for people receiving chemotherapy for cancer. It is not approved for the treatment of anemia associated with heart failure.

Enrollment Status: OPEN