Trial Outcomes & Findings for Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure (NCT NCT04514458)

NCT ID: NCT04514458

Last Updated: 2025-07-01

Results Overview

Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1410 participants

Primary outcome timeframe

Assessed from the date of randomization to 30 days post-randomization

Results posted on

2025-07-01

Participant Flow

100 providers were identified and consented to the study. 93 were randomized to the intervention group (alert) (n=46) or to usual care (no alert) group (n=47). This created 93 clusters (providers) to which eligible patient participants were assigned on their first eligible clinic visit. Eligible patient subjects were automatically identified, enrolled and randomized by our best practice alert based on their provider's randomization status (685 to the intervention group and 625 to usual care).

7 provider subjects were excluded prior to randomization as patient recruitment finished before these providers saw an eligible patient.

Participant milestones

Participant milestones
Measure
EHR-based Alert
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
Providers will not receive an alert and will proceed with usual care.
Overall Study
STARTED
735
675
Overall Study
Patient Subjects Enrolled
685
625
Overall Study
Provider Subjects Enrolled
50
50
Overall Study
COMPLETED
731
672
Overall Study
NOT COMPLETED
4
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Total
n=1310 Participants
Total of all reporting groups
Age, Continuous
72 years
n=5 Participants
72 years
n=7 Participants
72 years
n=5 Participants
Sex: Female, Male
Female
207 Participants
n=5 Participants
195 Participants
n=7 Participants
402 Participants
n=5 Participants
Sex: Female, Male
Male
478 Participants
n=5 Participants
430 Participants
n=7 Participants
908 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
67 Participants
n=5 Participants
58 Participants
n=7 Participants
125 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
614 Participants
n=5 Participants
559 Participants
n=7 Participants
1173 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
8 Participants
n=7 Participants
12 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
9 Participants
n=5 Participants
11 Participants
n=7 Participants
20 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
119 Participants
n=5 Participants
118 Participants
n=7 Participants
237 Participants
n=5 Participants
Race (NIH/OMB)
White
492 Participants
n=5 Participants
447 Participants
n=7 Participants
939 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
64 Participants
n=5 Participants
48 Participants
n=7 Participants
112 Participants
n=5 Participants
Medicaid/Medicare Enrollee
535 Participants
n=5 Participants
582 Participants
n=7 Participants
1117 Participants
n=5 Participants
Medical History
Atrial Arrhythmias
349 Participants
n=5 Participants
342 Participants
n=7 Participants
691 Participants
n=5 Participants
Medical History
Coronary Artery Disease (CAD)
262 Participants
n=5 Participants
208 Participants
n=7 Participants
470 Participants
n=5 Participants
Medical History
Chronic Kidney Disease (CKD)
241 Participants
n=5 Participants
212 Participants
n=7 Participants
453 Participants
n=5 Participants
Medical History
Depression
124 Participants
n=5 Participants
99 Participants
n=7 Participants
223 Participants
n=5 Participants
Medical History
Diabetes
260 Participants
n=5 Participants
235 Participants
n=7 Participants
495 Participants
n=5 Participants
Medical History
Dyslipidemia
524 Participants
n=5 Participants
500 Participants
n=7 Participants
1024 Participants
n=5 Participants
Medical History
Hypertension
583 Participants
n=5 Participants
531 Participants
n=7 Participants
1114 Participants
n=5 Participants
Medical History
Obesity
145 Participants
n=5 Participants
130 Participants
n=7 Participants
275 Participants
n=5 Participants
Medical History
Chronic Pulmonary Disorders
202 Participants
n=5 Participants
199 Participants
n=7 Participants
401 Participants
n=5 Participants
Medical History
Peripheral Vascular Disease
386 Participants
n=5 Participants
392 Participants
n=7 Participants
778 Participants
n=5 Participants
Baseline Blood Pressure
Systolic blood pressure
120 mmHg
n=5 Participants
118 mmHg
n=7 Participants
120 mmHg
n=5 Participants
Baseline Blood Pressure
Diastolic blood pressure
70 mmHg
n=5 Participants
70 mmHg
n=7 Participants
70 mmHg
n=5 Participants
Baseline Heart Rate
74 beats/minute
n=5 Participants
74 beats/minute
n=7 Participants
74 beats/minute
n=5 Participants
Patients per provider type
Number of patients seen by physician
467 Participants
n=5 Participants
438 Participants
n=7 Participants
905 Participants
n=5 Participants
Patients per provider type
Number of patients seen by Advanced Practice Providers
218 Participants
n=5 Participants
187 Participants
n=7 Participants
405 Participants
n=5 Participants
Number of patients on GDMT classes at baseline
Beta blockers
581 Participants
n=5 Participants
517 Participants
n=7 Participants
1098 Participants
n=5 Participants
Number of patients on GDMT classes at baseline
ACE-I/ARB/ARNI
489 Participants
n=5 Participants
437 Participants
n=7 Participants
926 Participants
n=5 Participants
Number of patients on GDMT classes at baseline
Angiotensin Converting Enzyme Inhibitor (ACE-I)
93 Participants
n=5 Participants
96 Participants
n=7 Participants
189 Participants
n=5 Participants
Number of patients on GDMT classes at baseline
Angiotensin Receptor Blocker (ARB)
102 Participants
n=5 Participants
91 Participants
n=7 Participants
193 Participants
n=5 Participants
Number of patients on GDMT classes at baseline
Angiotensin Receptor/Neprilysin Inhibitor (ARNI)
294 Participants
n=5 Participants
250 Participants
n=7 Participants
544 Participants
n=5 Participants
Number of patients on GDMT classes at baseline
Aldosterone Receptor Antagonist (MRA)
193 Participants
n=5 Participants
186 Participants
n=7 Participants
379 Participants
n=5 Participants
Number of patients on GDMT classes at baseline
Sodium-Glucose cotransporter-2 inhibitor (SGLT2i)
83 Participants
n=5 Participants
62 Participants
n=7 Participants
145 Participants
n=5 Participants
Baseline Potassium
4.2 mEq/L
n=5 Participants
4.3 mEq/L
n=7 Participants
4.3 mEq/L
n=5 Participants
Baseline Creatinine
1.2 mg/dL
n=5 Participants
1.2 mg/dL
n=7 Participants
1.2 mg/dL
n=5 Participants
Baseline estimated Glomerular Filtration Rate (eGFR)
56.9 ml/min/1.73m^2
n=5 Participants
58.4 ml/min/1.73m^2
n=7 Participants
57.8 ml/min/1.73m^2
n=5 Participants
Baseline Left Ventricular Ejection Fraction (LVEF)
32 percent ejection fraction
n=5 Participants
32 percent ejection fraction
n=7 Participants
32 percent ejection fraction
n=5 Participants

PRIMARY outcome

Timeframe: Assessed from the date of randomization to 30 days post-randomization

Population: Observed in patient subjects only.

Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy
176 Participants
117 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 30 days post-randomization

Assessed as the number of patients with prescribed beta blockers

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Percentage of Patients on Beta Blockers
606 Participants
521 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 30 days post-randomization

Assessed as the number of patients with a prescribed ACEi

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Percentage of Patients on ACE Inhibitors
83 Participants
92 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 30 days post-randomization

Assessed as the number of patients with a prescribed ARB

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Percentage of Patients on ARBs
111 Participants
85 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 30 days post-randomization

Assessed as the number of patients with a prescribed ARNI

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Percentage of Patients on ARNIs
334 Participants
285 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 30 days post-randomization

Assessed as the number of patients with a prescribed MRA

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Percentage of Patients on MRAs
232 Participants
203 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 30 days post-randomization

Assessed as the number of patients with a prescribed SGLT2i

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Percentage of Patients on SGLT2 Inhibitors
144 Participants
103 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization

Assessed as the number of patients who expired from randomization up to one year from any cause.

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Rate of One-year All-cause Mortality
75 Participants
68 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization

Number of participants with a hospitalization within 30 days of randomization

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Rate of 30-day Hospital Admission
47 Participants
63 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization

Number of participants with an emergency department visit within 30 days of randomization.

Outcome measures

Outcome measures
Measure
EHR-based Alert
n=685 Participants
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Usual Care
n=625 Participants
Providers will not receive an alert and will proceed with usual care.
Rate of 30-day All-cause Emergency Department Visits
86 Participants
77 Participants

SECONDARY outcome

Timeframe: Assessed from the date of randomization to 6 months post-randomization

Population: The data necessary to analyze this outcome was unable to be released from the university analytics team, therefore we cannot report cost results. The Finance Administration at Yale did not grant approval for access to this data. The data was not collected and will not be accessed in the future.

Assessed as total direct and indirect cost of patient care from randomization to 6 months post randomization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed 6 months post-randomization

Population: Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.

Proportion of prescriptions filled as assessed by SureScripts

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at 6 months post-randomization

Population: Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at 6 months post-randomization

Population: Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at 6 months post-randomization

Population: Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at 6 months post-randomization

Population: Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at 6 months post-randomization

Population: Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at 6 months post-randomization

Population: Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.

Outcome measures

Outcome data not reported

Adverse Events

EHR-based Alert

Serious events: 0 serious events
Other events: 0 other events
Deaths: 75 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 68 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tariq Ahmad

Yale University

Phone: 203-843-1667

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place