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RecruitingNCT06129799Updated Nov 13, 2023

Exercise CMR in (p)LF-LG AS

An observational study in Aortic Stenosis, Severe, sponsored by University of Göttingen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by University of Göttingen · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.

02

Conditions studied

  • Aortic Stenosis, Severe
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

University of Göttingen is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients prior to TAVR

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • paradoxical or conventional severe low-flow low-gradient aortic stenosis

Exclusion criteria

Exclusion Criteria:

  • CMR incapable device
  • unable to undergo 40 min scan (can not lie flat, claustrophobia)
  • renal insufficiency ( \<30 ml/min/1.73m²)
  • allergy against contrast agent
  • unable to exercise in supine position
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • paradoxical LF-LG AS
  • conventional LF-LG AS
06

What researchers measure

Primary outcomes

  1. Composite of events: number of participants with cardiovascular death or heart failure hospitalisation

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06129799
Lead sponsor
University of Göttingen
Responsible party
Sören Backhaus (Principal Investigator, University of Göttingen) — Principal investigator
First posted
Nov 13, 2023
Start date
Nov 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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