Usefulness of Ivabradine in the diagnosis of valvular heart disaease.

Low-flow Low-gradient Aortic Stenosis – Diagnostic Usefullness of Ivabradine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002015-17-DK

Enrollment

Registered

2016-09-02

Start date

2017-03-10

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic valve stenosis with reduced ejection fraction MedDRA version: 19.0 Level: PT Classification code 10002918 Term: Aortic valve stenosis System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Ivabradine Product Code: s16257 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVABRADINE CAS Number: 155974

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Low-flow (SV index 18 years 3. Signed informed consent 4. Heart rate > 60 beats per minute Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Other moderate-severe valvular heart disease other than AS 2. Unwilling to participate in the study 3. Mental disorder precluding informed consent 4. Poor echocardiographic window 5. Chronic atrial fibrillation 6. Sinus node dysfunction 7. Bradycardia < 60 BPM 8. Complete AV block or permanent cardiac pacemaker 9. Hypotension <90/50 mmHg 10. Concomitant treatment with diltiazem or verapamil 11. Liver dysfunction with ALAT twice upper limit of normal. 12. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to examine the safety and feasibility of oral admission of Ivabradine to patients with low-flow low-gradient severe Aortic stenosis (AS) and to compare the ability of Ivabradine with Dobutamine in differentiating true-severe AS from pseudo-severe AS. Primary objective In a population of patients with low-flow low-gradient severe AS with LVEF<50% to compare a. Changes in heart rate b. Changes in invasively measured SV, pulmonary wedge pressure (PCWP), mean pulmonary artery pressure (mPAP) and mean arterial pressure (MAP) c. Changes on echocardiography in LVEF, SV, global longitudinal strain, diastolic E/e’, mean and peak gradient, RV function and pulmonary pressure estimated by the tricuspid regurgitation gradient. After intravenous administration of Ivabradine compared to conventional low dose Dobutamine infusion ; Secondary Objective: Safety 1. In a population of patients with low-flow low-gradient severe AS to monitor a. Occurrence of bradycardia with heart rate <40 beats per min. b. Occurrence of symptoms (shortness of breath, angina, dizziness) c. Occurrence of cardiac arrhythmias on continuous ECG monitoring. ; Primary end point(s): a. Changes in heart rate b. Changes in invasively measured SV, pulmonary wedge pressure (PCWP), mean pulmonary artery pressure (mPAP) and mean arterial pressure (MAP) c. Changes on echocardiography in LVEF, SV, global longitudinal strain, diastolic E/e’, mean and peak gradient, RV function and pulmonary pressure estimated by the tricuspid regurgitation gradient. ;Timepoint(s) of evaluation of this end point: Will be evaluated every half our during the first 8 hours after administration.	—

Measure

Time frame

Main Objective: The purpose of this study is to examine the safety and feasibility of oral admission of Ivabradine to patients with low-flow low-gradient severe Aortic stenosis (AS) and to compare the ability of Ivabradine with Dobutamine in differentiating true-severe AS from pseudo-severe AS. Primary objective In a population of patients with low-flow low-gradient severe AS with LVEF<50% to compare a. Changes in heart rate b. Changes in invasively measured SV, pulmonary wedge pressure (PCWP), mean pulmonary artery pressure (mPAP) and mean arterial pressure (MAP) c. Changes on echocardiography in LVEF, SV, global longitudinal strain, diastolic E/e’, mean and peak gradient, RV function and pulmonary pressure estimated by the tricuspid regurgitation gradient. After intravenous administration of Ivabradine compared to conventional low dose Dobutamine infusion ; Secondary Objective: Safety 1. In a population of patients with low-flow low-gradient severe AS to monitor a. Occurrence of bradycardia with heart rate <40 beats per min. b. Occurrence of symptoms (shortness of breath, angina, dizziness) c. Occurrence of cardiac arrhythmias on continuous ECG monitoring. ; Primary end point(s): a. Changes in heart rate b. Changes in invasively measured SV, pulmonary wedge pressure (PCWP), mean pulmonary artery pressure (mPAP) and mean arterial pressure (MAP) c. Changes on echocardiography in LVEF, SV, global longitudinal strain, diastolic E/e’, mean and peak gradient, RV function and pulmonary pressure estimated by the tricuspid regurgitation gradient. ;Timepoint(s) of evaluation of this end point: Will be evaluated every half our during the first 8 hours after administration.

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Secondary

Measure	Time frame
Secondary end point(s): 1. In a population of patients with low-flow low-gradient severe AS to monitor serious adverse events a. Occurrence of bradycardia with heart rate <40 beats per min. b. Occurrence of symptoms (shortness of breath, angina, dizziness) c. Occurrence of cardiac arrhythmias on continuous ECG monitoring. ; Timepoint(s) of evaluation of this end point: Patients will be hemodynamically monitored at our intensive care unit during the first 8 hours after administration of Ivabradine. This will take place at the intensive care unit of our hospital. If any sign of adverse events occur monitoring will continue Potential serious adverse events (expected and unexpected) will be registered. As part of the safety objective (see 3.2), serious adverse events (described section 3.2) will be reported to the Principal investigator of this study (Sponsor) and the Danish Medicines Agency. In case of suspected unexpected serious adverse events the Danish Medicines Agency will be informed prior to 7 days.	—

Measure

Time frame

Secondary end point(s): 1. In a population of patients with low-flow low-gradient severe AS to monitor serious adverse events a. Occurrence of bradycardia with heart rate <40 beats per min. b. Occurrence of symptoms (shortness of breath, angina, dizziness) c. Occurrence of cardiac arrhythmias on continuous ECG monitoring. ; Timepoint(s) of evaluation of this end point: Patients will be hemodynamically monitored at our intensive care unit during the first 8 hours after administration of Ivabradine. This will take place at the intensive care unit of our hospital. If any sign of adverse events occur monitoring will continue Potential serious adverse events (expected and unexpected) will be registered. As part of the safety objective (see 3.2), serious adverse events (described section 3.2) will be reported to the Principal investigator of this study (Sponsor) and the Danish Medicines Agency. In case of suspected unexpected serious adverse events the Danish Medicines Agency will be informed prior to 7 days.

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Countries

Denmark

Contacts

Public ContactJordi Dahl

Odense University Hospital

jordi.sanchez.dahl@rsyd.dk4523823016

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026