Trial Outcomes & Findings for Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF) (NCT NCT02827500)

NCT ID: NCT02827500

Last Updated: 2019-10-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 104 participants
• Primary outcome timeframe: 180 days
• Results posted on: 2019-10-01

Participant Flow

Subjects hospitalized with acute heart failure were randomized prior to discharge from September 2016- April 2018.

Participant milestones

Measure	Usual Care Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Overall Study STARTED	52	52
Overall Study COMPLETED	33	45
Overall Study NOT COMPLETED	19	7

Reasons for withdrawal

Measure	Usual Care Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Overall Study Death	7	3
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	3	1
Overall Study Missing primary endpoint data	3	1
Overall Study Other	5	1

Baseline Characteristics

Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)

Baseline characteristics by cohort

Measure	Usual Care n=52 Participants Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=52 Participants Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine	Total n=104 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 12 • n=5 Participants	56.5 years STANDARD_DEVIATION 14.8 • n=7 Participants	57.5 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	38 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	41 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: Intent to treat population

Outcome measures

Measure	Usual Care n=52 Participants Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=52 Participants Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Number of Participants Taking Ivabradine at 180 Days	6 Participants	21 Participants

SECONDARY outcome

Timeframe: baseline,180 days

Change from baseline is calculated as 180 days - baseline results. Heart rate results are obtained from vital sign assessment when available otherwise results from ECG assessment are used.

Outcome measures

Measure	Usual Care n=52 Participants Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=52 Participants Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Change in Heart Rate	-10.2 beats per minute Standard Deviation 20.6	0.9 beats per minute Standard Deviation 16.7

SECONDARY outcome

Timeframe: 180 days

Heart rate results are obtained from vital sign assessment when available otherwise results from ECG assessment are used from day 180.

Outcome measures

Measure	Usual Care n=52 Participants Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=52 Participants Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Heart Rate at 180 Days	85.4 beats per minute Standard Deviation 16.7	77.2 beats per minute Standard Deviation 16.9

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Measure	Usual Care n=52 Participants Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=52 Participants Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Number of Patients With Heart Rate <70 Bpm at 180 Days	11 Participants	20 Participants

SECONDARY outcome

Timeframe: baseline, 180 days

Population: Participants who completed the KCCQ at both timepoints.

Change from baseline is calculated as 180 day - baseline results. Scores range 0-100, where a higher score indicates a better outcome.

Outcome measures

Measure	Usual Care n=29 Participants Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=38 Participants Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Changes in Symptoms and Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	25.1 score on a scale Standard Deviation 23.9	23.2 score on a scale Standard Deviation 32

SECONDARY outcome

Timeframe: baseline, 180 days

Population: Participants who completed the PGA at both timepoints.

Change from baseline is calculated as 180 day - baseline results. Scores range 0-100, where a higher score indicates a worse outcome.

Outcome measures

Measure	Usual Care n=29 Participants Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=38 Participants Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Changes in Symptoms and Quality of Life as Measured by Patient Global Assessment (PGA)	13 score on a scale Standard Deviation 26	14.8 score on a scale Standard Deviation 29.4

Adverse Events

Usual Care

Serious events: 2 serious events

Other events: 10 other events

Deaths: 7 deaths

Pre-discharge Ivabradine

Serious events: 3 serious events

Other events: 1 other events

Deaths: 3 deaths

Serious adverse events

Measure	Usual Care n=52 participants at risk Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=52 participants at risk Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Nervous system disorders Toxic Encephalopathy	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Cardiac disorders Cardiac failure	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Cardiac disorders Ventricular Fibrillation	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Cardiac disorders Bradycardia	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.

Other adverse events

Measure	Usual Care n=52 participants at risk Placebo Comparator: usual care Usual Care: Placebo Comparator: usual care	Pre-discharge Ivabradine n=52 participants at risk Active Comparator: ivabradine ivabradine: Active Comparator: ivabradine
Cardiac disorders Bradycardia	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Gastrointestinal disorders Nausea	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Metabolism and nutrition disorders Decreased appetite	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Nervous system disorders Dizziness	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Skin and subcutaneous tissue disorders Hyperhydrosis	1.9% 1/52 • Number of events 1 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.
Vascular disorders Hypotension	7.7% 4/52 • Number of events 4 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.	0.00% 0/52 • Events through day 194 (6 month +/- 2 week window) Only events of interest, serious and unexpected events, and events related to ivabradine use in the opinion of the site investigators were collected.

Additional Information

Dr. Robert Mentz

Duke Clinical Research Institute

Phone: 919-668-7121

Email: robert.mentz@duke.edu

Results disclosure agreements

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