A Phase 2/3 interventional study of Valsartan and Placebo Oral Tablet in Aortic Valve Stenosis, Valsartan and Angiotensin Receptor Antagonists, sponsored by University Hospital, Limoges. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by University Hospital, Limoges · Phase 2/3, Interventional, and Treatment
Among 130 studies in Aortic Valve Stenosis with a site in France — 21 open to participants now, 33 under way, 2 of them phase 3. Aortic Valve Stenosis · France.
Among the 130 studies in Aortic Valve Stenosis with a site in France, this one is the 65th largest by enrollment of the 68 interventional ones that give a count, is one of 6 that started in 2023, is the only one in phase 2/3, and was the 71st registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
Browse Aortic Valve Stenosis studies →21 of the 130 studies in Aortic Valve Stenosis with a site in France 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 and older · all sexes · no healthy volunteers.
The full table on the hub →130 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 6 started in 2023.
Median enrollment 179 across the 68 interventional studies, 470 across the 62 observational. Of the 79 that completed or were terminated, 13 (16%) have results posted.
49 of 130 have an industry lead sponsor. The 10 most frequent:
University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.
University Hospital, Limoges has 1 study filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
7 of the studies in Aortic Valve Stenosis with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06215378Phase 3Assistance Publique - Hôpitaux de ParisAntagonization of Heparin With Protamine Sulfate After TAVI | 2027-03-01 |
| NCT03728049University Hospital, LilleVon Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes | 2026-12 |
| NCT02972008University Hospital, LilleIdentification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly | 2027-02 |
| NCT05932615Abbott Medical DevicesENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | 2027-04 |
| NCT07520591Cardiawave SAValvosoft Outcomes Registry for Real-World Evidence | 2027-06-30 |
Among the 130 studies in Aortic Valve Stenosis with a site in France, from their registry updates:
Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter aortic valve replacement [TAVR]) in severe AS, as soon as symptoms or left ventricular (LV) dysfunction occur, in order to improve clinical outcome and achieve LV mass (LVM) regression. The highest amount of LVM regression is obtained during the first year. Nevertheless, there is heterogeneity in LV remodeling and residual LV hypertrophy is associated with poorer postoperative improvement in cardiac function and morphology. Incomplete regression of LV hypertrophy at 12 months after SAVR is a powerful predictor of adverse outcome. Yet, the use of specific pharmacological therapy to improve postoperative LVM regression could be an appealing therapeutic option after aortic valve intervention.
Renin-angiotensin-aldosterone system blockers (RAASb) and more particularly angiotensin-II receptor blockers (ARBs) are efficient in reducing LVM in hypertensive patients, as emphasized by several meta-analyses. In addition, ARBs improve myocardial relaxation, diastolic function, decreased hypertrophy and may have anti-fibrotic effects. In a recent retrospective study from our group, RAASb prescription after SAVR was associated with increased survival, but confirmation through a randomized trial is mandatory. In a prospective randomized single-center study, the use of candesartan was associated both with LV and LA remodeling as compared to the conventional management. Nevertheless, these results are based on echocardiographic data, which is not the gold standard for the assessment cardiac remodeling, and no placebo or active comparator was tested to control the impact of ARBs in these patients.
The primary objective of this Phase II study is to investigate the efficacy of valsartan, introduced postoperatively, as compared to placebo, on 1-year changes in indexed LVM, as assessed by CMR, in patients undergoing aortic valve intervention (SAVR or TAVR) for AS.
The secondary objectives are to compare the efficacy of valsartan vs. placebo in terms of one-year changes (difference from baseline) in cardiac function and in cardiac morphology, one-year exercise capacity and one-year changes in biomarkers related to cardiac function. In addition, the assessment of the safety of valsartan will also be considered as secondary objective.
The ARISTOTE trial is a multicenter prospective phase II, randomized, double-blind study including patients with the diagnosis of severe AS and indication for valve intervention.
The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist.
Patients will be randomized between 2 groups (valsartan versus placebo) and the treatment will be initiated (80 mg daily) at 5±4 days following aortic valve intervention. The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group.
The patients will be cautiously monitored and any adverse events will be collected. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study. The tolerance will be regularly assessed and dose adjusted according to a pre-specified algorithm.
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:
Secondary 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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist. The treatment will be initiated (80 mg, daily) at 5±4 days following aortic valve intervention. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study.
Drug: Valsartan
The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group.
Drug: Placebo Oral Tablet
The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist. The treatment will be initiated (80 mg, daily) at 5±4 days following aortic valve intervention. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study.
The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group.
Indexed left ventricular mass
the 1-year change from baseline in indexed LVM after aortic valve intervention as assessed using cardiac magnetic resonance (CMR)
Time frame: Day 0 to Year 1
Left ventricular global longitudinal strain
The 1-year change from baseline in left ventricular global longitudinal strain quantified using CMR
Time frame: Day 0 to Year 1
Left ventricular global longitudinal strain
The 1-year change from baseline in Left ventricular global longitudinal strain quantified using transthoracic echocardiography (TTE)
Time frame: Day 0 to Year 1
Left atrial volume
The 1-year change from baseline in Left atrial volume quantified using CMR
Time frame: Day 0 to Year 1
Left atrial volume
The 1-year change from baseline in Left atrial volume quantified using TTE
Time frame: Day 0 to Year 1
Indexed left ventricular mass
the 1-year change from baseline in indexed LVM after aortic valve intervention as assessed using TTE (real-time 3D)
Time frame: Day 0 to Year 1
Native T1
the 1-year change from baseline in native T1 using CMR
Time frame: Day 0 to Year 1
Rate of late gadolinium enhancement (LGE)
the 1-year change from baseline in rate of LGE using CMR
Time frame: Day 0 to Year 1
Volume of late gadolinium enhancement (LGE)
the 1-year change from baseline in volume of LGE using CMR
Time frame: Day 0 to Year 1
Extra cellular volume
The 1-year change from baseline in extra cellular volume using CMR
Time frame: Day 0 to Year 1
Indexed interstitial volume
The 1-year change from baseline in Indexed interstitial volume using CMR
Time frame: Day 0 to Year 1
Electrocardiographic strain
The 1-year change from baseline in Electrocardiographic strain
Time frame: Day 0 to Year 1
Left ventricular ejection fraction
The 1-year change from baseline in Left ventricular ejection fraction using CMR
Time frame: Day 0 to Year 1
Left ventricular ejection fraction
The 1-year change from baseline in Left ventricular ejection fraction using TTE
Time frame: Day 0 to Year 1
Peak exercise VO2
The 1-year measurement of Peak exercise VO2
Time frame: Year 1
VE/VCO2 ratio
The 1-year measurement of VE/VCO2 ratio
Time frame: 1 year
Maximal load
The 1-year maximal load reached
Time frame: 1 year
New-York heart association functional class
The 1-year assessment of New-York heart association functional class
Time frame: 1 year
Exercise oscillatory ventilation rate
The 1-year quantification of exercise oscillatory ventilation rate
Time frame: 1 year
Nt-pro Brain natriuretic peptide
The 1-year change from baseline in level of Nt-pro Brain natriuretic peptide using immunoassay
Time frame: Day 0 to Year 1
Plasma cardiac troponin I
The 1-year change from baseline in concentration of Plasma cardiac troponin I using high-sensitivity assay
Time frame: Day 0 to Year 1
Incidence of treatment-Emergent Adverse Events
Clinical occurrence of adverse events (AEs) and serious adverse events (SAEs) during the duration of the study period ending month 13
Time frame: Day 1 to Month 13
Start is estimated for Jan 2023; primary completion for Jul 2025, 30 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Valsartan
University Hospital, Limoges →