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Clinical Trials/EUCTR2021-004271-14-DK
EUCTR2021-004271-14-DK
Active, Not Recruiting
Phase 1

Effect of Dapagliflozin on myocardial and renal function following aortic valve stenosis intervention - DAPAS

Aarhus University Hospital, department of Cardiology0 sites104 target enrollmentOctober 20, 2021
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ConditionsPatients with aortic stenosis undergoing trans catheter aortic valve replacement.MedDRA version: 20.0Level: LLTClassification code 10058186Term: Aortic valve stenosis and insufficiencySystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with aortic stenosis undergoing trans catheter aortic valve replacement.
Sponsor
Aarhus University Hospital, department of Cardiology
Enrollment
104
Status
Active, Not Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 20, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Aarhus University Hospital, department of Cardiology

Eligibility Criteria

Inclusion Criteria

  • •1\. Signed informed consent
  • •2\. Scheduled TAVR for significant symptomatic AS according to current guidelines
  • •3\. Age \> 18 years and \< 85 years.
  • •\- LVEF \>/\= 40% and 50% with LV GLS \- LV septum or posterior wall thickness \>/\= 12mm by echo or LV mass index \>108/131 g/m2 for females/males (mild LVH)
  • •\- LVEF \> 50 % and Nt\-proBNP \> 600/900 ng/l (sinus rhythm/atrial fibrillation)
  • •5\. eGFR \> 30 mL/min/1\.73 m2
  • •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 14

Exclusion Criteria

  • •1\. Medically treated type 1 or type 2 diabetes mellitus
  • •2\. Ongoing treatment with an SGLT2\-inhibitor or intolerance to SGLT2\-inhibitors
  • •3\. Life expectancy \< 12 months
  • •4\. Symptomatic hypotension or persistent SBP \< 100 mmHg
  • •5\. Contraindications to CMRI
  • •6\. HF due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis or hypertrophic obstructive cardiomyopathy
  • •7\. Additional other untreated severe valvular disease
  • •8\. Liver failure
  • •9\. Women who are pregnant or plan to be within the study period.\*\*
  • •10\. Allergy to any substance in the project medicine, both placebo and active medicine.

Outcomes

Primary Outcomes

Not specified

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