Research Trials
Ongoing Trials
The consortium is currently enrolling subjects into two NIH network trials involving Acute decompensated Heart failure patients who are hospitalized.
Future Trials
Two Heart Failure trials begin enrolling in early 2007. Please check back for more information. If you are interested in volunteering or would simply like information about heart failure trials, contact Shari Mackedanz RN BSN CCRC: Shari.Mackedanz@hcmed.org, 612 347 5195.
Enrollment Opportunities
If you are interested in volunteering, email Shari Mackedanz to request more information.
Completed Trials
PROMISE - CRT (Prospective Minnesota Study of Echo tissue doppler imaging in Cardiac Resynchronization Therapy). (Enrollment ended 15 December 2006)
- Developed by MHFC investigators in conjunction with Guidant, Inc.
- PROMISE-CRT involves 70 patients at nine sites (including the University of Wisconsin and St. Marys' Duluth Clinic as satellites).
- When completed this will be the largest investigation to date regarding the utility of tissue-doppler imaging in the selection of patients for CRT therapy.
- As with RAPID, all aspects of study design and conduct are under the direct supervision of the MHFC.
- The results were presented at the 2007 Scientific Sessions of the Heart Rhythm Society of America (view the abstract).
EVEREST TRIAL - (Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized with Worsening Congestive Heart Failure.
The MHFC is serving as a coordinating center for the EVEREST Trial.
- A large multicenter study sponsored by Otsuka Pharmaceuticals.
- EVEREST is assessing the effect of the vasopressin antagonist tolvaptan on mortality and morbidity in patients with CHF.
- Six Consortium sites are participating and 33 subjects have been enrolled.
RAPID-CHF (Relief for Acute fluid-overloaded Patients with Decompensated Congestive Heart Failure).
- This study was designed by MHFC investigators in conjunction with CHF Solutions, a new biotechnology company based in the Twin Cities.
- RAPID was the first randomized controlled trial to compare a strategy of fluid removal using a new peripheral ultrafiltration system with diuretic-based care in decompensated HF.
- RAPID included 40 patients at six of the first MHFC sites.
- All aspects of the study, including the preparation of case-report form development, data collection, randomization of subjects, and site monitoring were conducted by the MHFC.
- The results, which were favorable for ultrafiltration, were presented at the 2004 Scientific Sessions of the Heart Failure Society of America, and have been accepted for publication in the December 2005 issue of the Journal of the American College of Cardiology (view the abstract).
- The results of RAPID led to the UNLOAD trial, a much larger nationwide trial with a similar design, but with sufficient power to assess outcomes. One of the MHFC sites, Hennepin County Medical Center, was part of UNLOAD, and randomized 13 patients. Results were presented at the March 2006 Scientific Sessions of the American College of Cardiology.
The MHFC has acted as the coordinating center in the following trials. Our role included contract/budget negotiations, site selection, site meeting coordination, site and sponsor communications and site payments.
PEECH trial (Enhanced External Counterpulsation in Heart Failure)
- A multi-center trial for EECP in heart failure patients sponsored by Vasomedical
- Three consortium sites partcipated
Astellas Inc
- A pilot trial for their vasopressin antagonist conivaptan in acute decompensated CHF
- Three consortium sites participated
