Study Summary
This trial is testing whether adding dapagliflozin to diuretic therapy can improve outcomes for people with or without type 2 diabetes who are hospitalized with acute decompensated heart failure.
Eligible Conditions
- Heart Failure
- Type 2 Diabetes
Treatment Effectiveness
Phase-Based Effectiveness
Phase 3
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Day 30
Day 5
Cumulative change in weight (kilograms)
Day 5
Incidence of worsening heart failure
Day 30
Hospital readmission
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2 Treatment Groups
Protocolized diuretic therapy
1 of 2
Protocolized diuretic therapy plus SGLT2 inhibitor therapy
1 of 2
Active Control
Experimental Treatment
240 Total Participants · 2 Treatment Groups
Primary Treatment: Protocolized Diuretic Therapy · No Placebo Group · Phase 3
Protocolized diuretic therapy plus SGLT2 inhibitor therapyExperimental Group · 2 Interventions: Dapagliflozin 10 MG, Protocolized Diuretic Therapy · Intervention Types: Drug, Other
Protocolized diuretic therapy
Other
ActiveComparator Group · 1 Intervention: Protocolized Diuretic Therapy · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 30
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
798 Previous Clinical Trials
640,226 Total Patients Enrolled
12 Trials studying Heart Failure
4,783 Patients Enrolled for Heart Failure
AstraZenecaIndustry Sponsor
4,051 Previous Clinical Trials
240,384,658 Total Patients Enrolled
74 Trials studying Heart Failure
112,608 Patients Enrolled for Heart Failure
JoAnn Lindenfeld, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
1,381 Total Patients Enrolled
2 Trials studying Heart Failure
1,381 Patients Enrolled for Heart Failure
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Mississippi | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| University of Mississippi Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Adams, Kirkwood F., Jr., Gregg C. Fonarow, Charles L. Emerman, Thierry H. LeJemtel, Maria Rosa Costanzo, William T. Abraham, Robert L. Berkowitz, Marie Galvao, and Darlene P. Horton. 2005. “Characteristics and Outcomes of Patients Hospitalized for Heart Failure in the United States: Rationale, Design, and Preliminary Observations from the First 100,000 Cases in the Acute Decompensated Heart Failure National Registry (ADHERE)”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2004.08.005.
- O'Connor, C.M., R.C. Starling, A.F. Hernandez, P.W. Armstrong, K. Dickstein, V. Hasselblad, G.M. Heizer, et al.. 2011. “Effect of Nesiritide in Patients with Acute Decompensated Heart Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1100171.
- Cox, Zachary L., and Daniel J. Lenihan. 2014. “Loop Diuretic Resistance in Heart Failure: Resistance Etiology–based Strategies to Restoring Diuretic Efficacy”. Journal of Cardiac Failure. Elsevier BV. doi:10.1016/j.cardfail.2014.05.007.
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- Voors, Adriaan A., Beth A. Davison, John R. Teerlink, G. Michael Felker, Gad Cotter, Gerasimos Filippatos, Barry H. Greenberg, et al.. 2014. “Diuretic Response in Patients with Acute Decompensated Heart Failure: Characteristics and Clinical Outcome—an Analysis from relax‐ahf”. European Journal of Heart Failure. Wiley. doi:10.1002/ejhf.170.
- Valente, M. A. E., A. A. Voors, K. Damman, D. J. Van Veldhuisen, B. M. Massie, C. M. O'Connor, M. Metra, et al.. 2014. “Diuretic Response in Acute Heart Failure: Clinical Characteristics and Prognostic Significance”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehu065.
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- Chen, Horng H., Kevin J. Anstrom, Michael M. Givertz, Lynne W. Stevenson, Marc J. Semigran, Steven R. Goldsmith, Bradley A. Bart, et al.. 2013. “Low-dose Dopamine or Low-dose Nesiritide in Acute Heart Failure with Renal Dysfunction”. Jama. American Medical Association (AMA). doi:10.1001/jama.2013.282190.
- ter Maaten, Jozine M., Mattia A.E. Valente, Kevin Damman, John G. Cleland, Michael M. Givertz, Marco Metra, Christopher M. O’Connor, et al.. 2016. “Combining Diuretic Response and Hemoconcentration to Predict Rehospitalization After Admission for Acute Heart Failure”. Circulation: Heart Failure. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circheartfailure.115.002845.
- Packer, Milton, Christopher O’Connor, John J.V. McMurray, Janet Wittes, William T. Abraham, Stefan D. Anker, Kenneth Dickstein, et al.. 2017. “Effect of Ularitide on Cardiovascular Mortality in Acute Heart Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1601895.
- Felker, G. Michael, Robert J. Mentz, Robert T. Cole, Kirkwood F. Adams, Gregory F. Egnaczyk, Mona Fiuzat, Chetan B. Patel, et al.. 2017. “Efficacy and Safety of Tolvaptan in Patients Hospitalized with Acute Heart Failure”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2016.09.004.
- Konstam, Marvin A., Michael Kiernan, Arthur Chandler, Ravi Dhingra, Freny Vaghaiwalla Mody, Howard Eisen, W. Herbert Haught, et al.. 2017. “Short-term Effects of Tolvaptan in Patients with Acute Heart Failure and Volume Overload”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2016.12.035.
- Voors, Adriaan A., Beth A. Davison, John R. Teerlink, G. Michael Felker, Gad Cotter, Gerasimos Filippatos, Barry H. Greenberg, et al.. 2014. “Diuretic Response in Patients with Acute Decompensated Heart Failure: Characteristics and Clinical Outcome—an Analysis from relax‐ahf”. European Journal of Heart Failure. Wiley. doi:10.1002/ejhf.170.
- Heerspink, Hiddo J.L., Bruce A. Perkins, David H. Fitchett, Mansoor Husain, and David Z. I. Cherney. 2016. “Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Diabetes Mellitus”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.116.021887.
- Teerlink, John R, Gad Cotter, Beth A Davison, G Michael Felker, Gerasimos Filippatos, Barry H Greenberg, Piotr Ponikowski, et al.. 2013. “Serelaxin, Recombinant Human Relaxin-2, for Treatment of Acute Heart Failure (RELAX-AHF): A Randomised, Placebo-controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(12)61855-8.
- ter Maaten, Jozine M., Allison M. Dunning, Mattia A.E. Valente, Kevin Damman, Justin A. Ezekowitz, Robert M. Califf, Randall C. Starling, et al.. 2015. “Diuretic Response in Acute Heart Failure—an Analysis from ASCEND-HF”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2015.05.003.
- Lala, Anuradha, Steven E. McNulty, Robert J. Mentz, Shannon M. Dunlay, Justin M. Vader, Omar F. AbouEzzeddine, Adam D. DeVore, et al.. 2015. “Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure”. Circulation: Heart Failure. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circheartfailure.114.001957.
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Frequently Asked Questions
Could you provide more context on how Protocolized Diuretic Therapy has been studied before?
"Protocolized Diuretic Therapy was first trialed in 2014 at The University of Texas Health Science Center at San Antonio. So far, there have been a total of 174 completed trials. Currently, 67 trials are still active, with a large portion of these taking place in Jackson, Mississippi." - Anonymous Online Contributor
Unverified Answer
What is the mortality rate for people who undergo Protocolized Diuretic Therapy?
"Protocolized Diuretic Therapy has been studied in multiple phase 3 trials, so it has been determined to be safe." - Anonymous Online Contributor
Unverified Answer
What conditions usually warrant Protocolized Diuretic Therapy?
"Protocolized Diuretic Therapy is a broad category of treatment that encompasses pharmaceuticals, diet and lifestyle changes, and other monotherapies." - Anonymous Online Contributor
Unverified Answer
Are there other hospitals in the state conducting this trial?
"There are a total of 12 different clinical trial sites, 6 of which are actively recruiting patients. The locations include the University of Mississippi Medical Center in Jackson, INTEGRIS in Oklahoma City, and Saint Thomas West Hospital in Chapel Hill." - Anonymous Online Contributor
Unverified Answer
How many people fit the bill to join this experiment?
"That is accurate. According to the information provided on clinicaltrials.gov, this study is looking for 240 subjects at 6 different sites. The posting date was April 1st, 2020 and the most recent update was February 1st, 2022." - Anonymous Online Contributor
Unverified Answer