Trial · NCT02827500

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

NCT02827500, Phase 4, Completed, Duke University; results first posted 2019-10-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF). Trials, record NCT02827500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02827500

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)
NCT number: NCT02827500
Status: Completed
Phases: Phase 4
Enrollment: 104 participants, actual
Lead sponsor: Duke University
Conditions: Heart Failure
Interventions: ivabradine, Usual Care
First posted: 2016-07-11
Last updated: 2019-10-01
Results first posted: 2019-10-01

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Taking Ivabradine at 180 Days	180 days
Secondary	Change in Heart Rate	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.
Secondary	Heart Rate at 180 Days	180 days	Heart rate results are obtained from vital sign assessment when available otherwise results from ECG assessment are used from day 180.
Secondary	Number of Patients With Heart Rate <70 Bpm at 180 Days	180 days
Secondary	Changes in Symptoms and Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	baseline, 180 days	Change from baseline is calculated as 180 day - baseline results. Scores range 0-100, where a higher score indicates a better outcome.
Secondary	Changes in Symptoms and Quality of Life as Measured by Patient Global Assessment (PGA)	baseline, 180 days	Change from baseline is calculated as 180 day - baseline results. Scores range 0-100, where a higher score indicates a worse outcome.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Taking Ivabradine at 180 Days	180 days	Intent to treat population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Heart Rate	baseline,180 days		beats per minute	MEAN
SECONDARY	Heart Rate at 180 Days	180 days		beats per minute	MEAN
SECONDARY	Number of Patients With Heart Rate <70 Bpm at 180 Days	180 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Symptoms and Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	baseline, 180 days	Participants who completed the KCCQ at both timepoints.	score on a scale	MEAN
SECONDARY	Changes in Symptoms and Quality of Life as Measured by Patient Global Assessment (PGA)	baseline, 180 days	Participants who completed the PGA at both timepoints.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants Taking Ivabradine at 180 Days	Usual Care	6		Participants
Number of Participants Taking Ivabradine at 180 Days	Pre-discharge Ivabradine	21		Participants
Change in Heart Rate	Usual Care	-10.2	Standard Deviation 20.6	beats per minute
Change in Heart Rate	Pre-discharge Ivabradine	0.9	Standard Deviation 16.7	beats per minute
Heart Rate at 180 Days	Usual Care	85.4	Standard Deviation 16.7	beats per minute
Heart Rate at 180 Days	Pre-discharge Ivabradine	77.2	Standard Deviation 16.9	beats per minute
Number of Patients With Heart Rate <70 Bpm at 180 Days	Usual Care	11		Participants
Number of Patients With Heart Rate <70 Bpm at 180 Days	Pre-discharge Ivabradine	20		Participants
Changes in Symptoms and Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	Usual Care	25.1	Standard Deviation 23.9	score on a scale
Changes in Symptoms and Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	Pre-discharge Ivabradine	23.2	Standard Deviation 32	score on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Usual Care	52
Overall Study	STARTED	Pre-discharge Ivabradine	52
Overall Study	COMPLETED	Usual Care	33
Overall Study	COMPLETED	Pre-discharge Ivabradine	45
Overall Study	NOT COMPLETED	Usual Care	19
Overall Study	NOT COMPLETED	Pre-discharge Ivabradine	7

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bradycardia	Cardiac disorders	Usual Care	1	52	1
other	Bradycardia	Cardiac disorders	Pre-discharge Ivabradine	1	52	1
other	Nausea	Gastrointestinal disorders	Usual Care	1	52	1
other	Nausea	Gastrointestinal disorders	Pre-discharge Ivabradine	0	52	0
other	Decreased appetite	Metabolism and nutrition disorders	Usual Care	1	52	1
other	Decreased appetite	Metabolism and nutrition disorders	Pre-discharge Ivabradine	0	52	0
other	Dizziness	Nervous system disorders	Usual Care	1	52	1
other	Dizziness	Nervous system disorders	Pre-discharge Ivabradine	0	52	0
other	Cough	Respiratory, thoracic and mediastinal disorders	Usual Care	1	52	1
other	Cough	Respiratory, thoracic and mediastinal disorders	Pre-discharge Ivabradine	0	52	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Usual Care	7	52
Total, all-cause mortality	Pre-discharge Ivabradine	3	52
Total, other adverse events	Usual Care	10	52
Total, other adverse events	Pre-discharge Ivabradine	1	52
Total, serious adverse events	Usual Care	2	52
Total, serious adverse events	Pre-discharge Ivabradine	3	52

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32217365	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pre-discharge Ivabradine vs Usual Care: Number of Patients With Heart Rate <70 Bpm at 180 Days	Trial comparisons
Pre-discharge Ivabradine vs Usual Care: Number of Participants Taking Ivabradine at 180 Days	Trial comparisons
Pre-discharge Ivabradine vs Usual Care: deaths from any cause	Trial comparisons
Pre-discharge Ivabradine vs Usual Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02827500

GET https://conductscience.org/api/trials/v1/NCT02827500/events?page=2

API reference For AI assistants