Trial Outcomes & Findings for Short Stay Unit vs Hospitalization in Acute Heart Failure (NCT NCT03302910)

NCT ID: NCT03302910

Last Updated: 2024-11-20

Results Overview

To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 194 participants
• Primary outcome timeframe: 30 day outcome
• Results posted on: 2024-11-20

Participant Flow

Participant milestones

Measure	Short Stay Unit Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Subjects who come to the ER with acute heart failure who are randomized to inpatient stay (i.e. usual care or hospitalization).
Overall Study STARTED	94	100
Overall Study COMPLETED	93	100
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Short Stay Unit Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Subjects who come to the ER with acute heart failure who are randomized to inpatient stay (i.e. usual care or hospitalization).
Overall Study Protocol Violation	1	0

Baseline Characteristics

Short Stay Unit vs Hospitalization in Acute Heart Failure

Baseline characteristics by cohort

Measure	Short Stay Unit n=93 Participants Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization n=100 Participants Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Subjects who come to the ER with acute heart failure who are randomized to inpatient stay (i.e. usual care or hospitalization).	Total n=193 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 14.3 • n=5 Participants	66.1 years STANDARD_DEVIATION 15.3 • n=7 Participants	64.8 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	47 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	53 Participants n=7 Participants	114 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity : Black	51 Participants n=5 Participants	57 Participants n=7 Participants	108 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity : White	38 Participants n=5 Participants	42 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity : Hispanic or Latino ethnicity	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants	100 participants n=7 Participants	193 participants n=5 Participants
Left Ventricular Ejection Fraction, mean (sd)	36.8 Percentage STANDARD_DEVIATION 16.5 • n=5 Participants	41.4 Percentage STANDARD_DEVIATION 15.3 • n=7 Participants	39.3 Percentage STANDARD_DEVIATION 16 • n=5 Participants

PRIMARY outcome

Timeframe: 30 day outcome

To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care

Outcome measures

Measure	Short Stay Unit n=89 Participants Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization n=95 Participants Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Hospitalization: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
Days Alive and Out of Hospital	26.9 Days Alive and Out of Hospital Interval 24.4 to 28.8	25.4 Days Alive and Out of Hospital Interval 22.0 to 27.7

SECONDARY outcome

Timeframe: 30 day outcome

To determine quality of life using a heart failure questionnaire. We used the Short KCCQ, and the overall summary KCCQ score. The score ranges from 0 to 100, with 100 being the best possible score. Differences of 5 or more points are considered clinically significant.

Outcome measures

Measure	Short Stay Unit n=65 Participants Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization n=68 Participants Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Hospitalization: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	51.3 score on a scale Standard Deviation 25.7	45.8 score on a scale Standard Deviation 23.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 and 90 days from randomization

Assessment of time to event for this composite outcome

Outcome measures

Measure	Short Stay Unit n=84 Participants Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization n=93 Participants Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Hospitalization: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
All Cause Mortality and Re-hospitalization 30 day all cause death or rehospitalization	16 participants	18 participants
All Cause Mortality and Re-hospitalization 90 day all cause death or rehospitalization	36 participants	35 participants

Adverse Events

Short Stay Unit

Serious events: 6 serious events

Other events: 15 other events

Deaths: 3 deaths

Hospitalization

Serious events: 6 serious events

Other events: 16 other events

Deaths: 4 deaths

Serious adverse events

Measure	Short Stay Unit n=93 participants at risk Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization n=100 participants at risk Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Hospitalization: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
Investigations Death	3.2% 3/93 • Number of events 3 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	4.0% 4/100 • Number of events 4 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Cardiac disorders CTCAE	0.00% 0/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	2.0% 2/100 • Number of events 2 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Gastrointestinal disorders CTCAE	1.1% 1/93 • Number of events 1 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	0.00% 0/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Hepatobiliary disorders CTCAE	1.1% 1/93 • Number of events 1 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	0.00% 0/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Renal and urinary disorders CTCAE	0.00% 0/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	1.0% 1/100 • Number of events 1 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Respiratory, thoracic and mediastinal disorders CTCAE	1.1% 1/93 • Number of events 1 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	0.00% 0/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.

Other adverse events

Measure	Short Stay Unit n=93 participants at risk Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Short Stay Unit: Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.	Hospitalization n=100 participants at risk Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Hospitalization: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
Blood and lymphatic system disorders CTCAE Category	0.00% 0/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	1.0% 1/100 • Number of events 1 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Cardiac disorders CTCAE	7.5% 7/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	5.0% 5/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Gastrointestinal disorders CTCAE	1.1% 1/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	0.00% 0/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Hepatobiliary disorders CTCAE	1.1% 1/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	0.00% 0/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Infections and infestations CTCAE	0.00% 0/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	1.0% 1/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Injury, poisoning and procedural complications CTCAE	1.1% 1/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	1.0% 1/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Metabolism and nutrition disorders CTCAE	0.00% 0/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	1.0% 1/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Renal and urinary disorders CTCAE	7.5% 7/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	7.0% 7/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Respiratory, thoracic and mediastinal disorders CTCAE	2.2% 2/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	2.0% 2/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Surgical and medical procedures CTCAE	1.1% 1/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	1.0% 1/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
Vascular disorders CTCAE	1.1% 1/93 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.	0.00% 0/100 • The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.

Additional Information

Peter S. Pang

Indiana University School of Medicine

Phone: 317-880-3900

Email: ppang@iu.edu

Results disclosure agreements

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