NCT02316587

Brief Summary

This observational cohort study studies the impact myocardial fibrosis has on patients with severe aortic stenosis undergoing aortic valve replacement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

December 10, 2014

Last Update Submit

April 3, 2017

Conditions

Endomyocardial FibrosisAortic Valve Stenosis

Keywords

Computerized TomographyMagnetic Resonance ImagingEchocardiographyRight Heart Catheterization

Outcome Measures

Primary Outcomes (1)

  • MACE (Major Adverse Cardiac Event)

    Major Adverse Cardiac Event defined as all-cause mortality or admission with heart failure

    2 years

Secondary Outcomes (1)

  • Cardiovascular mortality

    2 years

Other Outcomes (4)

  • NYHA change

    1 year

  • Functional capacity assessed by right heart catheterization and VO2-max test

    1 year

  • Extracellular volume quantification Assessed by biopsy, CT and MRi

    1 year

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with severe aortic valve stenosis.

You may qualify if:

  • Severe aortic valve stenosis (AVA ≤1cm2).
  • Scheduled for aortic valve replacement.
  • Signed consent

You may not qualify if:

  • At least moderate mitral regurgitation or stenosis.
  • Primary aortic insufficiency.
  • Persistent or permanent atrial fibrillation/flutter.
  • CKD with e-GFR \< 40 ml/kg/min.
  • Pacemaker or Implantable Cardioverter Defibrillator (ICD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (3)

  • Carter-Storch R, Mortensen NSB, Christensen NL, Ali M, Laursen KB, Pellikka PA, Moller JE, Dahl JS. First-phase ejection fraction: association with remodelling and outcome in aortic valve stenosis. Open Heart. 2021 Feb;8(1):e001543. doi: 10.1136/openhrt-2020-001543.

    PMID: 33574022DERIVED

  • Carter-Storch R, Dahl JS, Christensen NL, Pecini R, Sondergard EV, Ovrehus KA, Moller JE. Postoperative atrial fibrillation after aortic valve replacement is a risk factor for long-term atrial fibrillation. Interact Cardiovasc Thorac Surg. 2019 Sep 1;29(3):378-385. doi: 10.1093/icvts/ivz094.

    PMID: 30977792DERIVED

  • Carter-Storch R, Moller JE, Christensen NL, Irmukhadenov A, Rasmussen LM, Pecini R, Ovrehus KA, Sondergard EV, Marcussen N, Dahl JS. Postoperative Reverse Remodeling and Symptomatic Improvement in Normal-Flow Low-Gradient Aortic Stenosis After Aortic Valve Replacement. Circ Cardiovasc Imaging. 2017 Dec;10(12):e006580. doi: 10.1161/CIRCIMAGING.117.006580.

    PMID: 29222121DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma saved for biomarkers Endomyocardial biopsy Stenotic aortic valve

MeSH Terms

Conditions

Endomyocardial FibrosisAortic Valve Stenosis

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow Obstruction

Study Officials

  • Jacob E Møller, MD PhD DMsc

    Odense University Hospital

    STUDY DIRECTOR

  • Jordi S Dahl, MD, Ph.D.

    Odense University Hospital

    STUDY CHAIR

  • Kristian A Øvrehus, MD, Ph.D.

    Odense University Hospital

    STUDY CHAIR

  • Lars M Rasmussen, MD PhD DMsc

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 15, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations

DK(1)