Over the last two decades, MCSDs have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, occasionally as a bridge to recovery, and most recently as permanent implantation or "destination therapy" for intractable heart failure. Although heart transplantation offers life-saving therapy for selected patients, its use is limited by a supply of donor organs that currently meets less than one-tenth the need. As a consequence, the number of MCSD implantations has increased in recent years, and this trend is expected to continue especially in light of the October 1, 2003 decision of the Centers for Medicare and Medicaid Services (CMS) to provide reimbursement for MCSD implantation surgery.
Despite favorable survival and quality of life outcomes, MCSDs do have severe and sometimes life-threatening complications, including infection, thrombosis, and device failure. The development of new procedures and devices to reduce these complications will be expedited by the work of the registry involving the systematic, independent analysis of MCSD implantation procedures and outcomes. The National Heart, Lung, and Blood Institute (NHLBI) will collaborate with the CMS and the Food and Drug Administration in monitoring the work of the registry to permit the development of standard reporting of patient characteristics, indications, implantation procedures, and adverse events.
The goals of the registry include the following:
- Develop standard methods to collect data and specimens used to characterize heart failure patients receiving MCSDs, and develop methods of collecting demographic data of device use patient outcomes
- Collect, process, and store patients' clinical
| age group: | 0 to 99 years |
trial start date: | February 16, 2007 |
| Gender Preference: | none |
Trial End Date: | November 1, 2015 |
| Contact Info: | Jennifer Franzwa, RN at jennifer-franzwa@uiowa.edu
Julie Shepherd, RN at julie-shepherd@uiowa.edu |
| Keywords: | Cardiomyopathy ; Cardiovascular Diseases ; CMTP ; Heart ; Heart Diseases ; Heart Failure ; Mechanical Circulatory Support ; Ventricular Assist Device (VAD)
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Principal Investigator: Frances Johnson, MD
This research study follows patients throughout their normal clinical care. This study looks at genes (DNA) and how they affect health and disease. This study is an investigator initiated trial.
This study is open to patients cared for by the University of Iowa Hospitals and Clinics Cardiology services. This study may lead to discoveries about heart and lung diseases. Through the Cardiomyopathy Treatment Program, this biobank collects blood and tissue samples. The blood samples are collected when you are getting labs drawn in the clinic. The blood samples are collected if there is a procedure already scheduled. All samples are stored for future research. This is a long term study collecting one blood sample each year. Information from the electronic medical records is also collected at the same time.
| age group: | 18 to 99 years |
trial start date: | February 16, 2007 |
| Gender Preference: | none |
Trial End Date: | February 16, 2015 |
| Contact Info: | Megan Escher
319-356-1028 |
| Keywords: | Cardiomyopathy ; Cardiovascular Diseases ; CMTP ; gene ; Heart ; Heart Diseases ; Heart Failure ; Molecular Pathways ; Pulmonary Hypertension ; Transplant ; Ventricular Assist Device (VAD)
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Principal Investigator:Frances Johnson, MD
The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing all cause mortality in patients who have heart failure with preserved systolic function.
This study is closed to enrollment and in the follow-up phase.
Please refer to www.clinicaltrials.gov identifier NCT00094302 for more information.
| age group: | 50 to 99 years |
trial start date: | August 1, 2006 |
| Gender Preference: | none |
Trial End Date: | July 31, 2013 |
| Contact Info: | Cardiomyopathy Treatment Program
Page Scovel, RN
phone: 319-356-1028
fax: 319-356-7087
email: page-scovel@uiowa.edu |
| Keywords: | Cardiac disease ; Cardiomyopathy ; CHF ; Congestive heart failure ; Diastolic dysfunction ; Heart ; Heart Failure ; Preserved systolic function
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