Minnesota Heart Failure Consortium (MNHFC)
Improving outcomes. Enhancing lives.
The Minnesota Heart Failure Consortium (MNHFC) is a collaboration of healthcare professionals dedicated to improving outcomes in patients with heart failure, a common condition that occurs when the heart cannot pump enough blood and oxygen to meet the body's needs. The MNHFC facilitates clinical trials conducted at multiple institutions across the Midwest. Working together with sponsors and contract research organization (CROs), we investigate new heart failure treatment options to help patients who are living with this condition. In addition, the MNHFC provides educational opportunities for physicians and nurses to increase awareness about the most recent advances in heart failure care.
About the MNHFC
Throughout its history, the MNHFC has engaged in many different types of clinical research. These studies include investigator-initiated trials, which began within the MNHFC; participating in larger Phase III industry-sponsored trials; as well as being one of the initial eight Regional Clinical Centers in the first Heart Failure Network (HFN) developed by the National Heart, Lung and Blood Institute.
Within the HFN, the MNHFC was among the clinics with the highest number of participants enrolled in clinical trials, and was recognized as the top Regional Clinical Centers when enrollment and endpoint completion metrics were combined. Our investigators also developed and oversaw the completion and publication of one of the first four trials completed by the HFN – CARRESS-HF. This trial was the first, and to date the only, clinical trial comparing treatment strategies in cardiorenal syndrome complicating acute heart failure.
The MNHFC has the capacity to rapidly access many clinical databases in order to conduct registry-type studies, and we recently completed a “real world” review of the impact of implanted pulmonary artery pressure monitoring.
We maintain ongoing collaborative agreements with 13 hospitals and medical centers throughout Minnesota and South Dakota. With these agreements in place and full-time dedicated staff, the MNHFC can facilitate enrollment, as well as monitor the conduct of all types of clinical trials, from registries to those in acute heart failure to those in chronic heart failure.
The MNHFC formally launched in September 2002. Steven R. Goldsmith, MD, Professor of Medicine at the University of Minnesota and Director of the Heart Failure Program at Hennepin Healthcare HCMC, has led the MNHFC since its beginning.
“The Consortium is committed to conducting innovative clinical research in order to discover new treatments designed to improve and extend the lives of patients with heart failure.”
— Steven R. Goldsmith, MD, Director of MNHFC
Steven Goldsmith, MD, graduated from The Ohio State University where he also completed his residency training in internal medicine. He completed a fellowship in cardiology from the University of Minnesota. Dr. Goldsmith is the director of the heart failure program within the Division of Cardiology at HCMC, a Professor of Medicine at the University of Minnesota, and director of the Minnesota Heart Failure Consortium.
Areas of Practice
- Phase 2-4 pharmacological research
- Device trials: investigational and post marketing trials
- Investigator-initiated research
- Outcome trials
- Feasibility trials
- Registry trials
Investigational Product Administration
- Blood draws and IV placement
- Stress Tests
- 12 lead ECG
- Pharmokenetics & BioMarker processing
The MNHFC can help facilitate your clinical trials. We offer high-quality results in a timely, efficient and cost-effective manner. As a centralized point-of-contact for 11 investigative facilities, we have the ability to place your study in the optimal site and offer the customized services and oversight to meet your research study needs. Our services include:
- Protocol Development
- Site Selection, including determining site interest and a quick turnaround for site surveys
- Contract/Budget Negotiation
- Centralized Site Reimbursement
- Data Management/Case Report Form Development
- Regulatory Support, including consent development and regulatory document collection
- Trial Monitoring and Meeting Preparations
- Medical Writing, including Publications
The MNHFC can assist you in all stages in conducting clinical trials -- from protocol development, trial management and data analysis, to publication.
We have master agreements in place with our sites that enable us to streamline the contractual process. The confidentiality clause for protocol review requires that only one confidentiality agreement needs to be signed for protocol feasibility review by all sites. Centralized contracts, budgets and payments simplify the process for sponsors.
The MNHFC also provides a framework for discussions among our sites and sponsors/CROs.
MHFC investigators are nationally and internationally known thought leaders with decades of collective experience in many areas of heart failure research.
- Each site has a dedicated research staff with multiple years of research experience including ICH/GCP guidelines and several staff are certified coordinators.
- Sites are both academic and private settings with access to many patients within the Minneapolis-St. Paul community, ensuring a diverse patient population. Site demographics are available.
- Each site has secured ambient, refrigerated study drug storage and secured medical records/CRF storage. In addition, sites have access to laboratory facilities with freezer and centrifuge capabilities.
Hennepin Healthcare HCMC
Minneapolis VA Health Care System Hospital
Fairview University of Minnesota Hospital
University of Minnesota Physicians at Fairview
CentraCare Heart & Vascular Center
Minneapolis Heart Institute Foundation
North Memorial Heart & Vascular Institute
Metropolitan Heart and Vascular Institute
Park Nicollet Medical Center
The MNHFC has acted as the coordinating center in the following trials. Our role included contract/budget negotiations, site regulatory management, site selection, study training and monitoring oversight, study communications, and site payments.
Upper Midwest CardioMems registry developed by the MHFC and funded by St. Jude Medical. September 2016 through January 2018.
NIH Heart Failure Network Trials: 2006 - 2011 MHFC was a Regional Coordinating Center.
- ROSE-HF Renal Optimization Strategies Evaluation in Acute Heart Failure
- EXACT-HF Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
- CARESS-HF Cardiorenal Rescue Study in Acute Decompensated Heart Failure
- DOSE-HF the Diuretic Optimization Strategies Evaluation in Acute Heart Failure
- RELAX-HF Phosphodiesterase-5 Inhibition to Improve Quality of Life and Exercise Capacity in Diastolic Heart Failure
Bank AJ, Kaufman CL, Kelly AS, Bums, KV, Adler SW, Rector, TS, Goldsmith SR, Olivari, M-TP, Tang C, Nelson L, Metzig A. Results of the PROspective Minnesota study of ECHO/TDIi in Cardiac Resynchronization Therapy (PROMISE-CRT) Study. J Card Fail. 2009;15(5)401-409.
Bart BA, Goldsmith SR, Lee KL, Givertz MM, O'Connor CM, Bull DA, et al. Ultrafiltration in Decompensated Heart Failure with Cardiorenal Syndrome. N Engl J Med. 2012;367(24):2296-2304.
Bart BA, Goldsmith SR, Lee KL, Redfield MM, Felker GM, O'Connor CM. Cardiorenal Rescue Study in Acute Decompensated Heart Failure: Rationale and Design of CARRESS-HF. J Card Fail. 2012;18(3):176-182.
Bart BA, HFSA 2004 – 8th Annual Scientific Meeting – Abstract on the RAPID trial was presented.
Bart BA. (2005), Ultrafiltration Versus Usual Care for Hospitalized Patients With Heart Failure, The Relief for Acutely Fluid-Overloaded Patients With Decompensated Congestive Heart Failure (RAPID-CHF) Trial Journal of the American College of Cardiology. 2005; 46:2043-2046, doi:10.1016/j.jacc.2005.05.098 (Published online 2 November 2005) Bart, B. A., HFSA 2004 - 8th Annual Scientific Meeting - Abstract on the RAPID trial was presented.
Bart BA. Advances in Heart Failure: Minnesota's Role in the NHLBI's Heart Failure Network. Minnesota Medicine, January 2008, 40-42.
Chen HH, Anstrom KJ, Givertz MM, Stevenson LW, Semigran MJ, Goldsmith SR, et al. Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure with Renal Dysfunction: The ROSE Acute Heart Failure Randomized Trial. JAMA. 2013; 310(23):2533-2543. doi:10.1001/jarna.2013.282190.
Felker FM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, et al. Diuretic Strategies in Patients with Acute Decompensated Heart Failure. New Engl J Med 2011;364(9):797-805
Givertz MM, Anstrom KJ, Redfield MM, Deswal A, Haddad H, Butler J, Tang WH, Dunlap ME, LeWinter MM, Mann DL, Felker GM, O'Connor CM, Goldsmith SR, et al. for the NHLBI Heart Failure Clinical Research Network. Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The EXACT-HF Study. Circulation. 2015;131(20):1763-1771.
Goldsmith SR, Bart BA, Boyle A, Bank AJ, Anand I, Olivari MT, Kraemer M, Mackedanz S, Sobotka PA, Schollmeyer M. Ultrafiltration vs Usual Care for Hospitalized Patients with Heart Failure: The Relief For Accutely Overloaded Patients with Decompensated Congestive Heart Failure (RAPID-CHF) Trial. J Am Coll Cardiol 2005;46(11):2043-2046.
Goldsmith Steven R., M.D., Mackedanz, Shari, RN (2004). Minnesota Heart Failure Consortium, A Collaborative Spirit Drives Research and Education. Minnesota Physician, XVIII (6), 30-31, 38.
Goldsmith, Steven, R., M.D., Mackedanz, Shari, RN (2004). Minnesota Heart Failure Consortium, A Collaborative Spirit Drives Research, Education. Minnesota Healthcare News, 2 (11), 14-15, 29.
Redfield MM, Chen HH, Borlaug BA, Semigran MJ, Lee KL, Lewis G, LeWinter MM, Rouleau JL, Bull DA, Mann DL, Deswal A, Stevenson LW, Givertz MM, Ofili EO, O'Connor CM, Felker GM, Goldsmith SR, et al. Effect of Phosphodiesterase-5 Inhibition on Exercise Capacity and Clinical Status in Heart Failure with Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2013;309(12):1268-1277.
Shari Mackedanz, RN, BSN, CCRC
Hennepin Healthcare Research Institute
701 Park Ave, Orange 5
Minneapolis MN 55415