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Heart Diseases clinical trials

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NCT ID: NCT04005989 Withdrawn - Clinical trials for Coronary Artery Disease

Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization

ADMIRE
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

Treatment of ischemic myocardium has been the subject of intense research in recent years and stem cell therapy is one of the great promises. The InCor laboratory has studied cells from different backgrounds as candidates for cell therapy in the context of myocardial infarction. Evidence in preclinical studies of the application of stromal (mesenchymal) adipose tissue (hASC) in the ischemic heart by both the InCor group (in the animal model in rodents and pigs) and others in the literature suggest relevant benefits on the decrease of deterioration post-infarction. More recently it has been demonstrated that it arises mainly from the formation of new vessels due to paracrine factors, which are secreted by the injected cells. There are currently no studies in Brazil in which the safety of injecting different doses of hASC cells into the heart has been particularly evaluated. Recently, two studies have demonstrated the clinical applicability of hASC in patients with peripheral ischemic disease and stroke. Thus, the objective of this work will be to test the hypothesis that the implantation of autologous stromal cells derived from adipose tissue combined with myocardial revascularization surgery in patients with coronary artery disease

NCT ID: NCT03997097 Withdrawn - Clinical trials for Pulmonary Hypertension

Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease

VU-INHIB
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. the investigators present the SV-INHIBITION study rationale, design and methods.The SV-INHIBITION trial is a nationwide multicentre, randomised, double blind, placebo-controlled, phase III study, aiming to evaluate the efficacy of sildenafil on the ventilatory efficiency during exercise, in teenagers and adult patients (>15 y.o.) with a SV. Patients with pulmonary arterial hypertension (mean pulmonary arterial pressure (mPAP) > 15 mmHg and trans-pulmonary gradient > 5 mmHg) measured by cardiac catheterisation, will be eligible. The primary outcome is the variation of the VE/VCO2 slope, measured by a cardiopulmonary exercise test, between baseline and 6 months of treatment. A total of 50 patients are required to observe a decrease of 5 ± 5 points in the VE/VCO2 slope, with a power of 90% power and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, 6 minute walk test, SV function, NT Pro BNP, VO2max, stroke volume, mPAP, trans-pulmonary gradient, SF36 quality of life score, safety and acceptability. This study aims to answer the question whether PDE5 inhibitors should be prescribed in patients with a SV. This trial has been built focusing on the 3 levels of research defined by the WHO: disability (exercise tolerance), deficit (SV function), and handicap (quality of life).

NCT ID: NCT03946462 Withdrawn - Acute Kidney Injury Clinical Trials

Nitric Oxide During CPB to Reduce AKI in Neonates

Start date: October 2021
Phase: Phase 1
Study type: Interventional

This is a prospective, randomized, double-blind, placebo-controlled pilot study to investigate whether supplemental Nitric Oxide (NO) gas delivered during cardiac surgery with cardiopulmonary bypass (CPB) reduces the incidence and impact of acute kidney injury (AKI) in neonates undergoing surgery for congenital heart disease (CHD), when compared to placebo gas

NCT ID: NCT03787082 Withdrawn - Clinical trials for Pulmonary Hypertension

Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension

Start date: December 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, single-center study to examine distinguishing features of the structure and function of the oral and gut microbiome in volunteers with PH in the breakdown of oral nitrate and effect on hemodynamics.

NCT ID: NCT03690245 Withdrawn - Clinical trials for Congenital Heart Defect

Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease

INSPIRE-CHD
Start date: December 18, 2018
Phase: N/A
Study type: Interventional

Before birth, the placenta (a structure with many blood vessels attached to the inside of your womb) and the umbilical cord (the umbilical cord is attached to the placenta) are sending oxygen and nutrients from the mother's blood through the umbilical cord to the baby. After a baby is born the cord is clamped and babies have to start breathing and support themselves. At the moment when a baby with congenital heart disease is born they will have their cord clamped immediately (this is called immediate cord clamping (ICC)). After ICC the clinical team will start to help a baby transition by carefully monitoring their oxygen saturation (give oxygen if needed), provide warmth, and dry and stimulate. Several animal studies have shown that clamping the cord right after birth might causes the baby to miss the benefits of receiving blood from the umbilical cord / placenta. Delayed Cord Clamping (DCC) is when the baby stays attached to the cord for a longer time. Studies show that DCC has many benefits especially for a newborn baby, such as higher iron storage, less need for blood transfusions, and improved circulation. This can be done while the baby is breathing on its own or while we help you baby breath (this is called resuscitation). This study aims to examine whether DCC while providing resuscitation in infants with CHD is helpful compared to immediate cord clamping. Prior to the birth of your baby, a sealed envelope will be opened and your baby will be randomly assigned to either the DCC with resuscitation group or the ICC group. 40 babies will be enrolled into this study, 20 in each group. In the DCC group, the umbilical cord will be clamped after 120 seconds during which time your baby will receive the care he/she requires by the NICU team. In the ICC group, the umbilical cord will be clamped immediately and he/she will be brought over the resuscitation bed to be cared for by the same team.

NCT ID: NCT03529916 Withdrawn - Clinical trials for Coronary Heart Disease

Endothelial Cell Gene Networks of CVD

Start date: May 21, 2018
Phase:
Study type: Observational

The objective of this study is to identify relevant signature gene networks of cardiovascular disease in endothelial cells derived from circulating endothelial progenitor cells of individuals with established cardiovascular disease (CVD).

NCT ID: NCT03438500 Withdrawn - Clinical trials for Coronary Artery Disease

Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

NCT ID: NCT03399162 Withdrawn - Clinical trials for Coronary Artery Disease

PRehabilitiation in Elective Frail and Elderly Cardiac Surgery PaTients

PREFECT
Start date: May 20, 2018
Phase: N/A
Study type: Interventional

Older and more frail adults are more often being referred for cardiac surgery. These patients are often in suboptimal health, and may be physically frail, malnourished, and have other conditions, such as diabetes, that complicate their recovery. Research suggests that a rehabilitation program prior to surgery may help improve participants' health and improve their fitness for surgery. Currently, a pre-operative rehabilitation workshop is offered at the University of Ottawa Heart Institute, but this interventional, randomized study will investigate whether a more comprehensive pre-operative regime, including structured weekly exercise program, is more effective at improving health prior to surgery. Patients will be randomized to either the control group (pre-operative rehabilitation workshop ONLY) or the treatment group (pre-operative rehabilitation workshop plus exercise regime). This regime will attempt to improve patients' overall health, including their physical fitness and nutritional status. The effectiveness of this regime will be evaluated by comparing patients' physical function, questionnaires (diet, quality of life, stress) and serum biomarkers from baseline to pre-surgery to post-surgery. The Investigators hypothesize that patients that complete the pre-operative rehabilitation program will improve their health prior to surgery, and that this may result in shorter length of hospitalization and fewer complications after surgery. The study will take place over two years, with each patient's participation lasting about 3 months.

NCT ID: NCT03289104 Withdrawn - Heart Diseases Clinical Trials

Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX

Closure
Start date: September 2018
Phase: N/A
Study type: Interventional

The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage could improve bone healing, patient function, and decreased postoperative pain.

NCT ID: NCT03282292 Withdrawn - Clinical trials for Congenital Heart Disease

Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

PRECiSE
Start date: September 12, 2017
Phase: N/A
Study type: Interventional

Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization.