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Calcinosis clinical trials

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NCT ID: NCT04705506 Completed - Clinical trials for Diabetic Nephropathies

Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Start date: February 5, 2017
Phase: N/A
Study type: Interventional

Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.

NCT ID: NCT04686175 Active, not recruiting - Clinical trials for Generalized Arterial Calcification of Infancy

Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ENPP1 Deficiency

Start date: November 21, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of INZ-701, an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) enzyme replacement therapy, for the treatment of ENPP1 Deficiency. The goal of the study is to identify a dose regimen for further clinical development in the treatment of ENPP1 Deficiency.

NCT ID: NCT04583462 Recruiting - Type 1 Diabetes Clinical Trials

Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

IMPACT-1D
Start date: June 2, 2021
Phase: Phase 3
Study type: Interventional

Vascular calcification (VC) is a complication frequently observed in elderly, in chronic kidney disease (CKD) and in diabetes (particularly in type 1 diabetes). VC is a dynamic pathophysiological process that causes cardiovascular morbidity and is an independent risk factor of major amputation. In vitro and human observational studies have suggested a role of metformin in preventing VC. The investigators propose to test the effect of metformin treatment during two years on lower limb arterial calcification evaluated by CT-scan in patients with type 1 diabetes and without CKD. This research is a phase III double blind randomized controlled trial consisting of 2 years double-blind treatment phase (patients randomized to metformin or placebo) in type 1 diabetic patients. The participants and the investigators will be blinded to the study medications taken during the double-blind treatment period

NCT ID: NCT04557345 Completed - Clinical trials for Aortic Valve Stenosis

Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.

Start date: January 1, 1990
Phase:
Study type: Observational

Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America. Previous evidence shows that aortic valve calcification is an active biological process associated with inflammation. The only actual treatment for severe aortic stenosis is surgical aortic valve replacement (AVR). The materials with which the different types of prostheses are manufactured could induce inflammation per se. Biological prostheses, an incomplete cell removal process and therefore, the presence of residual proteins of animal origin, could induce the immune system's response. In the manufacturing bioprosthesis at the "Ignacio Chávez" National Institute of Cardiology (INC), an evaluation was carried out in the early, and late post-surgical period, it was shown that the inflammatory response after six months is similar to that produced by mechanical prosthesis. This study's main objective is to evaluate the inflammatory response in patients with post-operated AVR due to biological or mechanical prosthetic valve through different plasma biomarkers in long-term follow-up. Research question What is the inflammatory response and calcification in patients who undergo aortic valve replacement for a manufactured prosthesis at the "Ignacio Chávez" National Institute of Cardiology in the long-term follow-up? Hypothesis Manufactured bioprostheses at the "Ignacio Chávez" National Institute of Cardiology show a similar or lower inflammatory response to imported bioprostheses or mechanical prostheses associated with less valve dysfunction and more outstanding durability.

NCT ID: NCT04556682 Completed - Clinical trials for Coronary Calcification

IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions

Start date: May 1, 2021
Phase:
Study type: Observational

This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation.

NCT ID: NCT04539418 Completed - Renal Disease Clinical Trials

Vitamin K2 Supplementation and Vascular Calcification

Start date: December 1, 2016
Phase: Phase 4
Study type: Interventional

Vascular calcification is the leading cause of death in patients with end stage renal disease (ESRD) in hemodialysis. The protein matrix Gla vitamin K dependent (MGP) is a potent inhibitor of the vascular calcification. Objective: To evaluate the effect of vitamin K2 on vascular calcification in patients on hemodialysis. Materials and Methods: A prospective, randomized, double-blind study will be performed. The study subjects will be divided into a control (1000 µl of saline) or treated group (1000 µl containing 2000 µg of Vitamin K2). Vitamin K2 will be administered three times a week intravenously at the end of each dialysis session. Blood samples for biochemical determinations and vascular calcification will be assessed before and after 6 months of treatment through carotid Doppler ultrasound.

NCT ID: NCT04429035 Recruiting - Clinical trials for Aortic Valve Stenosis

SLOW-Slower Progress of caLcificatiOn With Vitamin K2

Start date: September 23, 2019
Phase: N/A
Study type: Interventional

A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo on a daily basis as well. Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression. Correlation with Mitral annulus and ascending Aorta.Exclusion criteria: Chronic Kidney disease, Vitamin K antagonists, statins, age < 50 y.o,prosthetic valves,Aortic Valve area (AVA) < 1cm2 ,Vmax > 4 m/s

NCT ID: NCT04428177 Recruiting - Clinical trials for Coronary Artery Calcification

Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

CCS
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.

NCT ID: NCT04408430 Recruiting - Clinical trials for Mitral Regurgitation

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

MITRAL-II
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.

NCT ID: NCT04312139 Recruiting - Clinical trials for Aortic Valve Stenosis

Serum and Cellular Biomarkers for Aortic Valve Stenosis

AthenaValve
Start date: March 1, 2020
Phase:
Study type: Observational

AthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the assessment of severity and prognosis of progression of aortic valve stenosis (AS, a devastating disease without early diagnosis and medical treatment). Two independent clinical cohorts of patients will provide serum samples, along with tissue and serum of a validated animal model of the disease for evaluation of the early stages, in order to develop and validate a multiplexed Enzyme-linked Immunosorbent Assay kit (multiplex ELISA). Advanced bioinformatics analysis will facilitate the selection of the most promising molecules from integrated proteomics-transcriptomics-metabolomics data. The novel biomarkers will help clinicians to early diagnose patients at high risk and will pave the way for the experimental implementation of promising pharmaceutical therapies. Moreover, AthenaValve aims to shed light on the systemic cellular interplay of the same patients, by analyzing the circulating immune cell phenotypes of the subgroups of rapid and slow progression patients