Minnesota Heart Failure Consortium (MNHFC)

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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

Key Investigator

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

Experience

Phase 2-4 pharmacological research
Device trials: investigational and post marketing trials
Investigator-initiated research
Outcome trials
Feasibility trials
Registry trials

Investigational Product Administration

Intravenous
Intramuscular
Subcutaneous
Oral

Procedures

Echocardiogram
Infusions
Vitals
Blood draws and IV placement
Spirometry
Stress Tests
12 lead ECG
Pharmokenetics & BioMarker processing

Our Services

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.

Our Collaborators

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

Essentia Health

Minneapolis Heart Institute Foundation

Regions Hospital

North Memorial Heart & Vascular Institute

Metropolitan Heart and Vascular Institute

Park Nicollet Medical Center

Completed Trials

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

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 (PROMISE-CRT Abstract_HRS2008_Final).

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.

RAPID-CHF (Relief for Acute fluid-overloaded Patients with Decompensated Congestive Heart Failure)

This study was designed by MNHFC 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 MNHFC 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 MNHFC.
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.
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.

PEECH trial (Enhanced External Counterpulsation in Heart Failure)

Astellas Inc.

Publications

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 – 8^th 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.

Contact

Shari Mackedanz, RN, BSN, CCRC

Hennepin Healthcare Research Institute
701 Park Ave, Orange 5
Minneapolis MN 55415

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