Erasmus Medical Center — Biomedical Watch V2

Traitements4programmes

Essais2liés

Publications3liées

SourceDBlocale

Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Double-TAP post-dilatationRationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years). As many of these patients are expected to outlive their prosthetic valves, the durability of the valve becomes an increasingly critical factor. Hypoattenuated leaflet thickening (HALT), a finding on post-TAVI computed tomography (CT), occurs in approximately 20% of patients and is associated with bioprosthetic valve dysfunction. Balloon-expandable valves seem more susceptible to HALT with an occurrence rate of 21%, compared to 16% for self-expanding valves. A recent study identified underexpansion of the transcatheter heart valve prosthesis as a key predictor of HALT at 30 days, which in turn was associated with a sixfold increase in cardiovascular mortality and a threefold increase in all-cause mortality at 1 year. Moreover, data suggest that, in the absence of post-dilatation, more than 95% of balloon-expandable valve implants exhibit some degree of underexpansion. In contrast, routine post-dilatation enhances valve expansion and hemodynamic performance without significantly increasing adverse events. The double-TAP technique-re-inflation of the TAVI delivery balloon after initial valve deployment-achieves a 9-10% increase in valve frame expansion, potentially reducing HALT risk and improving long-term outcomes. Objective: To determine whether routine double-TAP post-dilatation after balloon-expandable TAVI is safe and can reduce the incidence of HALT. Study design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment. Study population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis Investigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation. Study design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment. Study population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis Investigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation.	Maladie coronarienne	Non applicable	À vérifier	Germany, Netherlands	À vérifier
K+ in CKD — Potassium Supplementation in CKDThe current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate \[eGFR\] 15 - 45 ml/min/1.73 m2).	Hypertension	Non applicable	À vérifier	Netherlands	À vérifier
K+ in CKD — Potassium Supplementation in CKDThe current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate \[eGFR\] 15 - 45 ml/min/1.73 m2).	Hypertension	Non applicable	À vérifier	Netherlands	À vérifier
Double-TAP post-dilatationRationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years). As many of these patients are expected to outlive their prosthetic valves, the durability of the valve becomes an increasingly critical factor. Hypoattenuated leaflet thickening (HALT), a finding on post-TAVI computed tomography (CT), occurs in approximately 20% of patients and is associated with bioprosthetic valve dysfunction. Balloon-expandable valves seem more susceptible to HALT with an occurrence rate of 21%, compared to 16% for self-expanding valves. A recent study identified underexpansion of the transcatheter heart valve prosthesis as a key predictor of HALT at 30 days, which in turn was associated with a sixfold increase in cardiovascular mortality and a threefold increase in all-cause mortality at 1 year. Moreover, data suggest that, in the absence of post-dilatation, more than 95% of balloon-expandable valve implants exhibit some degree of underexpansion. In contrast, routine post-dilatation enhances valve expansion and hemodynamic performance without significantly increasing adverse events. The double-TAP technique-re-inflation of the TAVI delivery balloon after initial valve deployment-achieves a 9-10% increase in valve frame expansion, potentially reducing HALT risk and improving long-term outcomes. Objective: To determine whether routine double-TAP post-dilatation after balloon-expandable TAVI is safe and can reduce the incidence of HALT. Study design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment. Study population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis Investigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation. Study design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment. Study population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis Investigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation.	Maladie coronarienne	Non applicable	À vérifier	Germany, Netherlands	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Double-TAP post-dilatation	Maladie coronarienne	Non applicable	NCT07872020	SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial	RECRUITING
K+ in CKD — Potassium Supplementation in CKD	Hypertension	Non applicable	NCT03253172	K+ in CKD — Potassium Supplementation in CKD	ACTIVE_NOT_RECRUITING

Publications

3

Molécule	Indication / population	Titre	Journal	Date
K+ in CKD — Potassium Supplementation in CKD		The "FIFTY SHADOWS" of the RALES Trial: Lessons about the Potential Risk of Dietary Potassium Supplementation in Patients with Chronic Kidney Disease.	Journal of clinical medicine
K+ in CKD — Potassium Supplementation in CKD		The Effect of Omega-3 Supplements on Renal Function Indices in Chronic Kidney Patients Undergoing Hemodialysis.	Nutrition and metabolic insights
K+ in CKD — Potassium Supplementation in CKD		Natriuretic response to an acute oral potassium load in healthy individuals and patients with chronic kidney disease: a randomized controlled trial.	Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association