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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02827500
Recruitment Status : Completed
First Posted : July 11, 2016
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Duke University

Brief 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 participants using ivabradine at 180 days. Secondary objectives are to assess the impact of predischarge initiation of ivabradine on:Heart Rate (Change in heart rate from baseline to 180 days and Median heart rate at 180 days) and Patient-Centered Outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and Patient Global Assessment (PGA)). Tertiary objectives will be to explore the impact of predischarge initiation of ivabradine on other assessments of evidence-based implementation of ivabradine and beta-blockers at 180 days. Evaluations will incorporate data based on whether or not indication status was retained and whether or not an ivabradine prescription was provided. Tolerability of ivabradine and adverse events during study follow-up.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: ivabradine Other: Usual Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)
Study Start Date : July 2016
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Ivabradine

Arm Intervention/treatment
Active Comparator: ivabradine
Active Comparator: ivabradine
Drug: ivabradine
Active Comparator: ivabradine
Other Name: Corlanor

Placebo Comparator: usual care
Placebo Comparator: usual care
Other: Usual Care
Placebo Comparator: usual care




Primary Outcome Measures :
  1. Number of Participants Taking Ivabradine at 180 Days [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Change in Heart Rate [ Time Frame: 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.

  2. Heart Rate at 180 Days [ Time Frame: 180 days ]
    Heart rate results are obtained from vital sign assessment when available otherwise results from ECG assessment are used from day 180.

  3. Number of Patients With Heart Rate <70 Bpm at 180 Days [ Time Frame: 180 days ]
  4. Changes in Symptoms and Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: 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.

  5. Changes in Symptoms and Quality of Life as Measured by Patient Global Assessment (PGA) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hospitalized with acute HF (primary or secondary diagnosis) based on clinician assessment
  2. A prior clinical diagnosis of HF (i.e., not a new diagnosis of heart failure during the current hospitalization)
  3. Most recent LVEF ≤ 35% and within 6 months of randomization or LVEF ≤ 25% within 12 months of randomization
  4. On optimal guideline-directed medical therapy for HFrEF (or previously deemed intolerant) as determined by the clinician including ACE-inhibitors or angiotensin receptor antagonists or neprilysin inhibition, aldosterone receptor antagonists, and maximally-tolerated doses of beta-blockers at the time of current evaluation (which may differ from long-term targets)

    • Maximally-tolerated doses of beta-blockers will be defined by the treating physician when considering aspects such as current dose relative to the target dose used in clinical trials, patient heart rate and blood pressure, and patient symptoms
    • Patients with intolerance or contraindication to beta-blocker use are eligible for enrollment (details will be documented in the case report form)
  5. Age >18 years
  6. Willingness to provide informed consent from the subject (or their guardian or legally authorized representative [LAR])
  7. On the day of planned randomization, all participants:

    • Must be in sinus rhythm with a resting heart rate >70 bpm as measured on ECG or 10-second rhythm strip
    • Must have a blood pressure of >90/50 mm Hg

Exclusion Criteria:

  1. Documented plan for uptitration of beta-blocker in the following 4 weeks
  2. Permanent atrial fibrillation or atrial flutter
  3. Patients with recent atrial fibrillation or flutter defined by either precipitating the current HF hospitalization or occurring during the current HF hospitalization
  4. History of untreated sick sinus syndrome, sinoatrial block, or second and third degree atrio-ventricular block
  5. Pacemaker with atrial or ventricular pacing (except biventricular pacing) >40% of the time
  6. Family history or congenital long QT syndrome
  7. Recent myocardial infarction (<2 months prior to screening) [troponin elevation secondary to acute HF as determined by the clinician is not an exclusion]
  8. Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment
  9. Creatinine clearance <15 mL/min within 48 hours of screening that was not due to acute kidney injury that resolved
  10. Planned mechanical circulatory support within 180 days
  11. Pregnant or breastfeeding women. Women with child-bearing potential should use effective contraception.
  12. Medical conditions likely to lead to poor non-cardiac survival at 180 days (e.g., cancer)
  13. Inability to comply with planned study procedures
  14. If the following medications are needed at inclusion or during the study:

    • Non-dihydropyridine calcium channel blockers (e.g., diltiazem and verapamil)
    • Class I anti-arrhythmics (e.g., quinidine, procainamide, lidocaine, phenytoin)
    • Strong inhibitors of cytochrome P450 3A4 (CYP3A4), including some macrolide antibiotics (e.g., clarithromycin, erythromycin), cyclosporine, antiretroviral drugs (e.g., ritonavir, nelfinavir), and systemic azole antifungal agents (e.g., ketoconazole, itraconazole), and nefazodone
    • Inducers of cytochrome P450 3A4 (CYP3A4) including St. John's wort, rifampicin, barbiturates, and phenytoin.
    • Treatments known to be associated with significant prolongation of the QT interval, including sotalol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827500


Locations
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Sponsors and Collaborators
Duke University
Amgen
Investigators
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Principal Investigator: Robert Mentz, MD Duke Clinical Research Institute
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] July 19, 2017
Statistical Analysis Plan  [PDF] January 11, 2019


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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02827500    
Other Study ID Numbers: Pro00071309
First Posted: July 11, 2016    Key Record Dates
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases