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Clinical Trials/EUCTR2016-002015-17-DK
EUCTR2016-002015-17-DK
Active, not recruiting
Phase 1

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

Odense University Hospital0 sites25 target enrollmentSeptember 2, 2016
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ConditionsAortic valve stenosis with reduced ejection fractionMedDRA version: 19.0 Level: PT Classification code 10002918 Term: Aortic valve stenosis System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Aortic valve stenosis with reduced ejection fraction
Sponsor
Odense University Hospital
Enrollment
25
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 2, 2016
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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