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NCT02827500 · ClinicalTrials.gov registry record · Phase 4
Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 104
- Enrollment target
NCT02827500 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 104 participants.
The verdict
NCT02827500, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 104 participants
- Enrollment target
Study Summary
The PRIME-HF study is a multi-center, patient-level, randomized, open-label study of approximately 450 patients with reduced (left ventricular ejection fraction) LVEF of ≤ 35% and heart-rate ≥70 beats per minute (bpm) who are being discharged from the hospital following stabilization from acute heart failure (HF)(primary or secondary) and will be randomized to a treatment strategy of predischarge initiation of ivabradine or usual care. All participants should have a follow-up visit within 7-14 days of hospital discharge. Heart rate and systolic blood pressure will be assessed at this clinical visit. For participants randomized to predischarge initiation of ivabradine and on ivabradine 5mg BID, the heart rate may be used to adjust the dose the dose to 2.5mg BID or 7.5mg BID. For participants randomized to usual care, ivabradine may be initiated at the provider's discretion. All participants will have a second follow-up study visit 6 weeks (42 +/- 14 days) post-discharge. Heart rate, systolic blood pressure and quality of life (KCCQ and PGA) will be assessed. For participants already taking ivabradine in either treatment group, the heart rate may again be used to adjust the dose of ivabradine. For participants not yet receiving ivabradine, it may be initiated at the provider's discretion. All participants will receive a 90 (+/-7) day post-discharge phone call by site to assess for event status and tolerability of ivabradine. All participants will have a final study visit at 180 (+/-14) days post-discharge. Heart rate, systolic blood pressure and quality of life (Kansas City Cardiomyopathy Questionnaire and Patient Global Assessment) will be assessed. The attending physician may initiate ivabradine per usual care clinical practice. The primary hypothesis of the PRIME-HF study is that, compared with usual care, a treatment strategy of initiation of ivabradine prior to discharge for a hospitalization with acute HF will be associated with a greater proportion of partici
Interventions
- OTHER Usual Care
- DRUG ivabradine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2016-07 |
| Est. Completion | 2018-10-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02827500
The ClinicalTrials.gov registry entry for NCT02827500 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT02827500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02827500 about?
NCT02827500 is a clinical study titled "Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)". The PRIME-HF study is a multi-center, patient-level, randomized, open-label study of approximately 450 patients with reduced (left ventricular ejection fraction) LVEF of ≤ 35% and heart-rate ≥70 beats per minute (bpm) who are being discharged from the hospital following stabilization from acute hear...
What is the current status of trial NCT02827500?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 104 participants. The study started on 2016-07. Estimated completion is 2018-10-15.
What interventions are being tested in trial NCT02827500?
The interventions under investigation include: Usual Care (OTHER), ivabradine (DRUG).
Who is sponsoring clinical trial NCT02827500?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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