TRANSFORM3: Evaluation of Implementation Strategies of Teaching, Technology, and Teams to Optimize Medical Therapy in Cardiovascular Disease (T3) (T3)

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    American College of Cardiology
Updated on 21 October 2022
medical therapy
ejection fraction
heart failure
vascular disease
Accepts healthy volunteers


This initiative supports a quality improvement effort evaluating the use of strategies (including technology-based decision support, referral to a virtual GDMT team, and general educational tools/resources for clinicians and patients) to improve use of guideline-directed therapeutics known to lower cardiovascular (CV) events among patients with cardiovascular diseases of heart failure, atrial fibrillation and type 2 diabetes (T2D)/ASCVD with a specific focus on underserved populations and those with a history of health care disparities.


TRANSFORM3 is a Quality Improvement initiative conducted in parallel to the current TRANSFORM CVRiD study and aligned with its goals of using a real-world population study to enable the American College of Cardiology Foundation ("ACCF") to better identify impactful ways to improve guideline directed medical therapy for patients. TRANSFORM3 is focused on improving GDMT use in underserved patients and patients with a history of health care disparities who have one or more of the following: heart failure, atrial fibrillation, and ASCVD/Type 2 diabetes.

There is a significant disconnect between increasing availability of effective and safe therapeutics that significantly reduce CV event risk in patients with Heart Failure, T2D and ASCVD, and Atrial Fibrillation-and clear guideline recommendations endorsing these therapies-but very low adoption in clinical practice with the majority of eligible patients that are most likely to benefit from these therapies not receiving them. A high proportion of patients have more than one of these conditions further reducing the chances of receiving optimal guideline directed medical therapy and avoiding the CV events they are designed to prevent.

Condition Heart Failure, Type 2 Diabetes, Atrial Fibrillation
Treatment Decision Support, Referral
Clinical Study IdentifierNCT05572814
SponsorAmerican College of Cardiology
Last Modified on21 October 2022


Yes No Not Sure

Inclusion Criteria

Age ≥18 years
Personal access to a computer and/or Smartphone for app download
Heart Failure (reduced and preserved ejection fraction) AND/OR
Atrial Fibrillation with CHA2DS2-VASc score greater than or equal to 2 in men and greater than or equal to 3 in women AND/OR
T2D and ASCVD, defined as follows
Known CAD, prior ACS, or coronary artery revascularization
Prior TIA/stroke or known carotid or intracerebral atherosclerosis
Prior PAD including requiring revascularization

Exclusion Criteria

All patients
Current or anticipated participation in an interventional clinical trial of a drug/device
Currently receiving comfort care or enrolled in hospice
Life expectancy <1 year
Pregnancy or active breastfeeding
Current or anticipated participation in an interventional clinical trial (other than TRANSFORM3 GDMT)
Patients without a clinical encounter within three years of study start date
Heart Failure patients
History of or plan for heart transplantation or left ventricular assist de-vice
Palliative chronic inotropic therapy
NYHA Class 4 heart failure
Atrial Fibrillation patients
Current prescription for OAC
Reversible cause of atrial fibrillation, such as post-cardiothoracic surgery or thyrotoxicosis
History of ischemic stroke in prior 7 days
Transient ischemic attack in prior 3 days
Platelet count <70,000/ml
Hemoglobin concentration <8g/dl
History of or condition associated with increased bleeding risk, such as hemophilia
Major surgical procedure or trauma within 14 days
Clinically significant gastrointestinal bleeding within 8 weeks
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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