Chinese Academy of Medical Sciences, Fuwai Hospital — Biomedical Watch V2

Traitements9programmes

Essais4liés

Publications11liées

SourceDBlocale

Traitements

9

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Biodegradable occluderMigraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants. Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\'s team, Professor Pan Xiangbin\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness. To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.	Migraine	Non applicable	Traitement symptomatique	China	À vérifier
doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the PrognosisHypertension is still one of the major preventable risk factor for cardiovascular as well as cerebrovascular diseases globally, including ischaemic heart disease, heart failure, and renal impairment. Despite knowledge on hypertension and the availability of effective antihypertensive medications have progressed dramatically in recent years, the rate of uncontrolled hypertension ( reached 90%) remains high in China\[1\]. Among those with uncontrolled hypertension，it has been reported that 8.9% in all individuals with hypertension, and 12.8% in the hypertensive drug-treated population\[2\] are attributed to resistant hypertension. Resistant hypertension has been defined by AHA as high blood pressure (BP) in spite of appropriate lifestyle interventions and treatment of three or more different types of antihypertensive drugs at optimal dose, including at least one diuretics\[3,4\] or achieving adequate BP control with optimal doses of 4 or more antihypertensive drugs. At present, not many specifically designed prospective researches concerning resistant hypertension are available. The prevalence of resistant hypertension is not well established and most knowledge about resistant hypertension derives from cross-sectional analyses and clinical trials. The patients with resistant hypertension have been expected to have server target damage, and worse prognosis than those who are non-resistant, but not well established either in the literature\[2\]. The purpose of this study is to determine the prevalence of resistant hypertension ascertained with systemic investigation and optimal treatment with antihypertensive drugs in community populations and clinic as well as the prognosis among patients with resistant hypertension compared with those who are non-resistant.	Hypertension	À vérifier	À vérifier	China	À vérifier
Metal occluderMigraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants. Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\'s team, Professor Pan Xiangbin\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness. To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.	Migraine	Non applicable	Traitement symptomatique	China	À vérifier
PFO occlusionMigraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.	Migraine	À vérifier	Traitement symptomatique	China	À vérifier
The tetralogy of medication regimenThe goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is: Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study.	SEP	À vérifier	À vérifier	China	À vérifier
PFO occlusionMigraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.	Migraine	À vérifier	Traitement symptomatique	China	À vérifier
doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the PrognosisHypertension is still one of the major preventable risk factor for cardiovascular as well as cerebrovascular diseases globally, including ischaemic heart disease, heart failure, and renal impairment. Despite knowledge on hypertension and the availability of effective antihypertensive medications have progressed dramatically in recent years, the rate of uncontrolled hypertension ( reached 90%) remains high in China\[1\]. Among those with uncontrolled hypertension，it has been reported that 8.9% in all individuals with hypertension, and 12.8% in the hypertensive drug-treated population\[2\] are attributed to resistant hypertension. Resistant hypertension has been defined by AHA as high blood pressure (BP) in spite of appropriate lifestyle interventions and treatment of three or more different types of antihypertensive drugs at optimal dose, including at least one diuretics\[3,4\] or achieving adequate BP control with optimal doses of 4 or more antihypertensive drugs. At present, not many specifically designed prospective researches concerning resistant hypertension are available. The prevalence of resistant hypertension is not well established and most knowledge about resistant hypertension derives from cross-sectional analyses and clinical trials. The patients with resistant hypertension have been expected to have server target damage, and worse prognosis than those who are non-resistant, but not well established either in the literature\[2\]. The purpose of this study is to determine the prevalence of resistant hypertension ascertained with systemic investigation and optimal treatment with antihypertensive drugs in community populations and clinic as well as the prognosis among patients with resistant hypertension compared with those who are non-resistant.	Hypertension	À vérifier	À vérifier	China	À vérifier
Biodegradable occluderMigraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants. Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\'s team, Professor Pan Xiangbin\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness. To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.	Migraine	Non applicable	Traitement symptomatique	China	À vérifier
The tetralogy of medication regimenThe goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is: Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study.	SEP	À vérifier	À vérifier	China	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
The tetralogy of medication regimen	SEP	À vérifier	NCT06553391	Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis	COMPLETED
Biodegradable occluder	Migraine	Non applicable	NCT06203873	BioMetal — A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine	RECRUITING
doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis	Hypertension	À vérifier	NCT01703780	doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis	UNKNOWN
PFO occlusion	Migraine	À vérifier	NCT06033937	COMPETE Cohort Study	UNKNOWN

Publications

11

Molécule	Indication / population	Titre	Journal	Date
Metal occluder		Comparison of biodegradable and metal occluders in patients with PFO and migraine: study design and rationale of BioMetal Trial.	Trials
Biodegradable occluder		The Safety and Efficacy of Absnow Fully Biodegradable Atrial Septal Defect Occluder: A Prospective, Single-Center Phase III Clinical Trial.	Clinical cardiology
Biodegradable occluder		Biodegradable devices for transcatheter patent foramen ovale closure: current evidence and future directions.	Expert review of cardiovascular therapy
Biodegradable occluder		Novel biodegradable device for transcatheter closure of atrial septal defects.	Scientific reports
doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis		Favorable Effects of Renal Denervation in Hypertension-Related Comorbidities. A Systematic Review and Meta-Analysis.	Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis		Durability of Blood Pressure Reduction After Renal Denervation in Resistant Hypertension: Mid-Term Real-World Outcomes From Kuwait.	Journal of clinical hypertension (Greenwich, Conn.)
PFO occlusion		Retrospective study on affecting factors and predictive model for guide wire failure to pass through the foramen ovale in PFO patients during interventional closure.	Medicine
doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis		Spironolactone therapy in resistant hypertension comorbid with mild obstructive sleep apnea: A retrospective cohort study.	Medicine
doublepres — The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis		Prevalence and prognostic significance of untreated, uncontrolled and resistant hypertension among American adults with prediabetes.	Blood pressure
PFO occlusion		Right-dominant arrhythmogenic cardiomyopathy complicated by platypnea-orthodeoxia syndrome: a novel mechanism of patent foramen Ovale-mediated hypoxaemia: a case report.	European heart journal. Case reports
PFO occlusion		Clinical Investigation of the Safety and Effectiveness of the Occlutech Flex II PFO Occluder: Design and Rationale of the Multicenter, Randomized OCCLUFLEX Trial.	Journal of the Society for Cardiovascular Angiography & Interventions