sefulness of Ivabradine in the diagnosis of valvular heart disaease.

Phase 1

• 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002015-17-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-02
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Inclusion criteria
1.Low-flow (SV index<35 ml/m2) low-gradient (meangradient <40 mmHg) AS with AVA<1,0 cm2
2.Age > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified