A Phase 2/3 interventional study of SGLT2 inhibitor and Placebo in Aortic Stenosis and Left Ventricle Hypertrophied, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by University of Aarhus · Phase 2/3, Interventional, and Treatment
Among 73 studies in Aortic Valve Stenosis with a site in Denmark — 13 open to participants now, 28 under way, none of them phase 3. Aortic Valve Stenosis · Denmark.
Among the 73 studies in Aortic Valve Stenosis with a site in Denmark, this one is the 27th largest by planned enrollment of the 40 interventional ones that give a count, is the only one that started in 2022, is the only one in phase 2/3, and was the 53rd registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 106 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →13 of the 73 studies in Aortic Valve Stenosis with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →73 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2022.
Median enrollment 214 across the 40 interventional studies, 200 across the 33 observational. Of the 37 that completed or were terminated, 10 (27%) have results posted.
29 of 73 have an industry lead sponsor. The 10 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 3 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Aortic Valve Stenosis with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04913870Institut universitaire de cardiologie et de pneumologie de Québec, University LavalAngiotensin Receptor Blockers in Aortic Stenosis | 2027-02 |
| NCT05932615Abbott Medical DevicesENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | 2027-04 |
| NCT06638268Rigshospitalet, DenmarkTranscatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock | 2027-07-01 |
| NCT06470022Christian Juhl TerkelsenComparison of Evolut FX Versus Sapien 3 Ultra Resilia. | 2027-07-14 |
| NCT06342635Sahajanand Medical Technologies LimitedHydra Single-centre Experience - Copenhagen, Denmark | 2027-09-30 |
Among the 73 studies in Aortic Valve Stenosis with a site in Denmark, from their registry updates:
Randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR.
This is a randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR. It evaluates the effect of Dapagliflozin versus placebo, given once daily in addition to background standard medical therapy. Patients who are scheduled for TAVR at Aarhus University Hospital (AUH) will be informed about the project and invited to participate if they fulfill the inclusion criteria prior to the TAVR procedure.
Patients will be randomized 1:1 in blocks of 6 patients to either Dapagliflozin 10 mg daily or placebo within 1 months prior to the scheduled TAVR therapy.
The total treatment period is 13 months with 6 scheduled outpatient clinic visits at baseline (before TAVR) and at 1, 3, 6, 9, 12 months after TAVR.
Cardiac magnetic resonance imaging (CMRI) is performed at baseline and 12 months follow-up. Echocardiography is performed at baseline, 1- and 12 months. 24-hour ambulatory blood pressure is measured at baseline and 12-months post-TAVR. Clinical status, HF questionnaire and blood samples will be performed at each visit. Drug accountability and adherence to the protocol is evaluated at each visit.
A sub study in 40 of the included patients (20 treated with Dapagliflozin and 20 placebo) is planned. This will include additional endomyocardial biopsies taken at baseline and 12-months follow-up for high resolution respirometry (mitochondrial function) and electron microscopy (mitochondrial structure and interstitial fibrosis) supplemented by right heart catherization (RHC) for hemodynamic assessment.
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.
*
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 mg (oral) SGLT-2 inhibitor once daily
Drug: SGLT2 inhibitor
Placebo tablet encapsulated as the active treatment.
Drug: Placebo
10 mg orally once daily in addition to standard medical treatment.
Placebo tablets similar to active treatment.
Composite endpoint of changes in LV mass, systolic function, eGFR, and serum Nt-proBNP
Changes from baseline to 12 months of follow-up in at least 2 out of 4 well-known parameters is required to reach the primary endpoint: * LVMi (grams) reduction of 10 % point (by CMRI) * LV GLS (percent) absolute increase of 2.0 % point (by TTE) * A decrease in serum Nt-proBNP (ng/L) of more than 25% * Relative increase of 10% in eGFR (ml/min/1.73m\^2) If 2 or more of the 4 outcome measures are reached at 12-months follow-up, the patient has fulfilled the primary end-point.
Time frame: Baseline assesment to 12-months follow-up post-TAVR
Difference in the change in eGFR
Difference between active treatment and placebo at 12-months follow-up
Time frame: baseline to 12-months
Difference in eGFR
Difference between active treatment and placebo at 12-months follow-up
Time frame: 12-months
The number of patients with a relative difference of 10 % of myocardial interstitial fibrosis evaluated by the biomarker extracellular volume (ECV) by late enhancement gadolinium by CMR
Difference between active treatment and placebo.
Time frame: Baseline to 12-months
The number of patients with a >10% decrease in cardiac fibrosis when assessed by histology and quantified by stereology (sub study)
Difference between active treatment and placebo.
Time frame: Baseline to 12-months
The number of patients with an increase in the respiratory control ratio (RCR) by ≥10% measured by High Resolution Respirometry (HRR) (sub study)
Difference between active treatment and placebo.
Time frame: Baseline to 12-months
Composite endpoint of worsening HF with hospitalization or urgent outpatient clinical visit due to HF, and all-cause mortality.
Difference between active treatment and placebo in the incidence rate of hospitalization due to worsening heart failure or urgent clinical visit due to heart failure and all-cause mortality (using dates of the events to assess the incidence rates in the two groups: active treatment and placebo.
Time frame: 12-months post-TAVR
All-cause mortality
Difference between active treatment and placebo.
Time frame: Baseline to 12-months post-TAVR
Worsening HF with hospitalization or urgent outpatient clinical visit due to HF
Difference between active treatment and placebo.
Time frame: 12-months post-TAVR
Difference in the change in urinary albumin/creatinine ratio
Difference between active treatment and placebo.
Time frame: Baseline to 12-months
Difference in ACR at 12-months follow-up
Difference between active treatment and placebo.
Time frame: 12-months follow-up
24-hour ambulatory blood pressure changes
Difference between active treatment and placebo in both systolic and diastolic blood pressure.
Time frame: baseline to 12 months
Change from baseline to 12-months follow-up in the Kansas City Cardiomyopathy questionnaire
Change from baseline in KCCQ will be reported. The KCCQ is a 23-item, self-administered questionnaire with score range of 0 to 100, and higher scores indicating better health. Difference in score for active treatment vs. placebo.
Time frame: Baseline to 12-months
Change from baseline to 12-months follow-up in New York Heart Association-class (NYHA)
The NYHA functional classification categorizes the extent of heart failure by placing subjects in one of four (I, II, III, IV) categories based on how much they are limited during physical activity and symptoms of shortness of breath and/or angina. Shift in NYHA-class between active treatment group and placebo.
Time frame: baseline to 12-months.
LVMi reduction of 10 % point (by CMRI)
Difference between active treatment and placebo.
Time frame: baseline to 12-months.
LV GLS absolute increase of 2.0 % point (by TTE)
Difference between active treatment and placebo.
Time frame: Baseline to 12-months follow-up
A decrease in serum Nt-proBNP of more than 25% follow-up
Difference between active treatment and placebo.
Time frame: baseline to 12-months follow-up.
Relative increase of 10% in eGFR
Difference between active treatment and placebo.
Time frame: Baseline to 12-months follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Mar 2024, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SGLT2 inhibitors