Study Summary
This trial is testing whether a clinical decision support tool can help improve heart failure risk stratification in patients with type 2 diabetes.
Eligible Conditions
- Heart Failure
- Type 2 Diabetes
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 12 months
12 months
Adherence of prescription of SGLT-2i medication at outpatient clinic visit
Frequency of incident HF
30 days
Frequency of prescription of SGLT-2i medication at outpatient clinic visits
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
No Alert
1 of 2
Electronic Alert
1 of 2
Active Control
Experimental Treatment
1500 Total Participants · 2 Treatment Groups
Primary Treatment: On-screen electronic alert · No Placebo Group · N/A
Electronic Alert
Behavioral
Experimental Group · 1 Intervention: On-screen electronic alert · Intervention Types: BehavioralNo AlertNoIntervention Group · 1 Intervention: No Alert · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
On-screen electronic alert
2018
N/A
~800
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
971 Previous Clinical Trials
1,114,311 Total Patients Enrolled
16 Trials studying Heart Failure
11,037 Patients Enrolled for Heart Failure
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Cavender, Matthew A., Ph. Gabriel Steg, Sidney C. Smith Jr, Kim Eagle, E. Magnus Ohman, Shinya Goto, Julia Kuder, Kyungah Im, Peter W.F. Wilson, and Deepak L. Bhatt. 2015. “Impact of Diabetes Mellitus on Hospitalization for Heart Failure, Cardiovascular Events, and Death”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.114.014796.
- McAllister, David A., Stephanie H. Read, Jan Kerssens, Shona Livingstone, Stuart McGurnaghan, Pardeep Jhund, John Petrie, et al.. 2018. “Incidence of Hospitalization for Heart Failure and Case-fatality Among 3.25 Million People with and Without Diabetes Mellitus”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.118.034986.
- Kannel, William B., Marthana Hjortland, and William P. Castelli. 1974. “Role of Diabetes in Congestive Heart Failure: The Framingham Study”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/0002-9149(74)90089-7.
- Segar, Matthew W., Muthiah Vaduganathan, Kershaw V. Patel, Darren K. McGuire, Javed Butler, Gregg C. Fonarow, Mujeeb Basit, et al.. 2019. “Machine Learning to Predict the Risk of Incident Heart Failure Hospitalization Among Patients with Diabetes: The WATCH-DM Risk Score”. Diabetes Care. American Diabetes Association. doi:10.2337/dc19-0587.
- Standl, Eberhard, Oliver Schnell, and Darren K. McGuire. 2016. “Heart Failure Considerations of Antihyperglycemic Medications for Type 2 Diabetes”. Circulation Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circresaha.116.306924.
- Zelniker, Thomas A, Stephen D Wiviott, Itamar Raz, Kyungah Im, Erica L Goodrich, Marc P Bonaca, Ofri Mosenzon, et al.. 2019. “SGLT2 Inhibitors for Primary and Secondary Prevention of Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Systematic Review and Meta-analysis of Cardiovascular Outcome Trials”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(18)32590-x.
- Benjamin, Emelia J., Salim S. Virani, Clifton W. Callaway, Alanna M. Chamberlain, Alexander R. Chang, Susan Cheng, Stephanie E. Chiuve, et al.. 2018. “Heart Disease and Stroke Statistics—2018 Update: A Report from the American Heart Association”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000558.
- Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
- Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available. Erratum In: Circulation. 2018 Mar 20;137(12 ):e493.
- Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Furtado RHM, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet. 2019 Jan 5;393(10166):31-39. doi: 10.1016/S0140-6736(18)32590-X. Epub 2018 Nov 10. Erratum In: Lancet. 2019 Jan 5;393(10166):30.
- Standl E, Schnell O, McGuire DK. Heart Failure Considerations of Antihyperglycemic Medications for Type 2 Diabetes. Circ Res. 2016 May 27;118(11):1830-43. doi: 10.1161/CIRCRESAHA.116.306924.
- Ambarish Pandey 2021. "Electronic Alerts for Heart Failure Prevention in Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04791826.
Frequently Asked Questions
How many participants have been recruited for this trial?
"Affirmative. According to clinicaltrials.gov, this medical investigation is actively recruiting participants and was first posted on March 25th 2021 before being updated most recently on November 30th 2022. Its ambition of 1500 individuals needs to be accomplished by 1 research centre." - Anonymous Online Contributor
Unverified Answer
Does this medical experiment have any openings for participants?
"Affirmative. Clinicaltrials.gov reports that this experiment, which was published on March 25th 2021, is currently recruiting patients. 1500 participants must be gathered at a single site for the trial to proceed." - Anonymous Online Contributor
Unverified Answer