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Heart Diseases clinical trials

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NCT ID: NCT03882788 Completed - Clinical trials for Congenital Heart Disease

The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)

NDO
Start date: April 22, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes to the wide variation in neurologic recovery and developmental outcome after surgery in infants with congenital heart disease.

NCT ID: NCT03882450 Completed - Dysphagia Clinical Trials

Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine how often heart or chest surgery in children leads to problems with the movement of the vocal folds.

NCT ID: NCT03877965 Completed - Clinical trials for Congenital Heart Disease

Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease

DGX01
Start date: August 5, 2019
Phase:
Study type: Observational

This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.

NCT ID: NCT03875651 Completed - Clinical trials for Coronary Artery Disease

A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)

Start date: May 9, 2019
Phase:
Study type: Observational

EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries > 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.

NCT ID: NCT03867903 Completed - Clinical trials for Congenital Heart Disease

BabySparks Developmental Application Pilot Study

Start date: March 14, 2019
Phase:
Study type: Observational

A single site, cross-sectional, pilot study of a mHealth application. Primary Objective This purpose of this pilot study is to evaluate mHealth adherence to a developmental application, Babysparks©, by parents of infants with complex congenital cardiac disease and single ventricle heart disease. Secondary Objective(s) -To determine the demographic and infant characteristics that correlate with mHealth adherence. -The rate of developmental progress of milestones while using the application will also be compared between infants with single ventricle cardiac disease and bi-ventricular cardiac disease. Research Intervention(s)/ Investigational Agent(s) Babysparks© developmental application is the main intervention with evaluation on feasibility of the mHealth application in a pediatric cardiology population. Study participants will be parents of infants with single ventricle and bi-ventricular complex congenital heart disease who underwent cardiac surgery in the first six weeks of life and are currently less than 18 months of age. Study Population There are approximately 150 new patients a year who have undergone cardiac surgery, with an additional 150 who are 18 months of age or less. Sample Size A maximum of 400 families/year Study Duration for Individual Participants Study participants will be monitored for a minimum of 6 months with the use of the BabySparks© App; to a maximum of 24 months of use of the app or when the child reaches a developmental age of 24 months, whichever occurs first. Study Specific Abbreviations/ Definitions mHealth : mobile health CHD: Congenital heart disease

NCT ID: NCT03867318 Completed - Clinical trials for Hypercholesterolemia

Efficacy and Safety Study of Ezetimibe (SCH 58235, MK-0653) in Addition to Atorvastatin in Participants With Coronary Heart Disease or Multiple Cardiovascular Risk Factors (P00693/MK-0653-030)

Start date: April 24, 2000
Phase: Phase 3
Study type: Interventional

The overall objective is to evaluate the efficacy and safety of ezetimibe (SCH 058235/MK-0653) 10 mg administered daily in conjunction with atorvastatin in participants with Heterozygous Familial Hypercholesterolemia (HeFH) or in participants with coronary heart disease (CHD) or multiple cardiovascular risk factors (≥2 risk factors) and primary hypercholesterolemia not controlled by a starting dose (10 mg/day) of atorvastatin. The primary hypothesis is that the coadministration of ezetimibe 10 mg/day with atorvastatin therapy will result in a significantly greater proportion of participants achieving target low-density lipoprotein cholesterol (LDL-C) (≤100 mg/dL) when compared to the atorvastatin administered alone.

NCT ID: NCT03860935 Completed - Heart Diseases Clinical Trials

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

ATTRibute-CM
Start date: March 19, 2019
Phase: Phase 3
Study type: Interventional

Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

NCT ID: NCT03860545 Completed - Acute Kidney Injury Clinical Trials

New Markers of Cardiac Surgery Related Acute Kidney Injury.

Start date: January 2, 2018
Phase:
Study type: Observational

Cardiac surgery related acute kidney injury (CS-AKI) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. In this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules perioperatively. There has been no official recommendations toward routine use of analysed biomarkers.

NCT ID: NCT03858257 Completed - Anesthesia Clinical Trials

High Flow Nasal Oxygen During Sedation

Start date: August 7, 2019
Phase: N/A
Study type: Interventional

The primary objective of this study is to test the hypothesis that using high flow nasal oxygen improves ventilation during cardiac implantable electronic device procedures performed with conscious sedation. A randomized controlled trial design will be used with participants randomized in a 1:1 ratio to oxygen supplementation through a standard facemask or high flow nasal oxygen.

NCT ID: NCT03856242 Completed - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia and Ischemic Heart DIsease

Start date: September 1, 2015
Phase: Phase 4
Study type: Interventional

To examine the dynamics of 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions resulted from benign prostatic hyperplasia (BPH) with the indications for either conservative or operative treatment. A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.