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Heart Diseases clinical trials

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NCT ID: NCT03657823 Recruiting - Clinical trials for Congenital Heart Disease

Fetal Growth and Pregnancy Complications Among Women With Heart Disease

PreCor
Start date: May 15, 2018
Phase:
Study type: Observational [Patient Registry]

An increasing proportion of women with heart disease now go through pregnancy and childbirth. More knowledge about the risk of complications and adverse outcomes for the mother and the baby is needed to guide clinical care in this diverse patient group. The purpose of this study is to, in a cohort of pregnant women with heart disease; - determine fetal growth, and risk of fetal growth restriction and preterm birth - determine whether maternal blood biomarkers are associated with development of preeclampsia, the time of delivery and maternal and perinatal adverse outcomes - determine the risk of hypertensive pregnancy complications The expected outcome of the project is to increase the knowledge of optimal diagnosis and treatment of women with heart disease that go through pregnancy to be able to improve clinical care and the outcomes for mother and baby.

NCT ID: NCT03626480 Recruiting - Clinical trials for Congenital Heart Disease

Peri-operative Nutrition in Infants With Congenital Heart Disease

Start date: July 9, 2018
Phase:
Study type: Observational

The purpose of our multi-center cohort study is to build a large platform to follow up the peri-operative nutrition of children with congenital heart disease. And data will be collected pre and 1, 3, 6, 12 months post surgery including physical, laboratory, imaging examination and questionnaire. The primary outcome is nutrition status (measured as WAZ, WHZ and HAZ) and secondary outcomes were the biochemical index and quality of life.

NCT ID: NCT03619395 Recruiting - Clinical trials for Acute Coronary Syndrome

Risc Optimisation- Acute cor5onary Syndrome

RiskOp-ACS
Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

This study evaluates the percentage of patients that reach the objective levels of LDL cholesterol, glycosylated hemoglobin and blood pressure recommended by clinical guidelines after an acute coronary syndrome, following strategies of pharmacological optimization based on algorithms. The investigators hypothesize that the use of algorithms designed and protocolized within a cardiac rehabilitation program after an ACS to optimize pharmacological treatment is effective and safe to improve the control of risk factors in patients with high cardiovascular risk.

NCT ID: NCT03613337 Recruiting - Clinical trials for Coronary Heart Disease

Effect of Smoking Status and Genetic Risk Factors on Restenosis and Efficacy of Clopidogrel After de Novo Percutaneous Coronary Intervention

Start date: May 1, 2018
Phase:
Study type: Observational

Restenosis occurs for many different reasons. Over the years, many predictive clinical, biological, genetic, epigenetic, lesion-related, and procedural risk factors for restenosis have been identified. Smoking is one of most important factors, however the results were contradictory. And the genetic factors of restenosis have been studied mostly in European populations. Based on literature review, study of candidate genes for restenosis in Chinese population was insufficient. With due attention to this matter mentioned above, the investigators aim to preliminary explore genetic variation and smoking effect on clinical restenosis in patients diagnosed with after percutaneous coronary intervention in the Chinese population, with correlation analysis of factors and gene-set analysis of biological pathways related to restenosis and platelet approach were widely used in this study.

NCT ID: NCT03595423 Recruiting - Valve Heart Disease Clinical Trials

SPAnish Aortic VALVE Multicentric Study

SPAVALVE
Start date: July 10, 2018
Phase:
Study type: Observational

Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B. Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era. The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 30 Cardiovascular Surgery Centers in Spain

NCT ID: NCT03563417 Recruiting - Clinical trials for Ischemic Heart Disease

ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO

ISCHEMIA-CTO
Start date: November 6, 2018
Phase: N/A
Study type: Interventional

Study design Prospective randomized open labeled multicenter study Hypotheses 1. In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events). 2. In symptomatic patients with ≥ 5% of myocardial ischemia: PCI with latest generation of drug eluting stents is superior to optimal medical therapy (OMT) in terms of improved life quality measured as an increase of SAQ (Self Assessment Questionnaire) score of 8 points after 6 months. Inclusion Criteria - CTO in native coronary artery - Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging. - Age ≥18 yrs. - Able to provide written Informed consent and willing to comply with the specified follow-up contacts - Target artery ≥ 2.5 mm Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into: Cohort A: Asymptomatic (CCS < 2 and SAQ QoL > 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO Cohort C: patients enrolled but not randomized in cohort A or B Exclusion criteria (for both cohort A and B) - NSTEMI or STEMI within 1 month - Coronary anatomy not suitable for CTO-procedure - Coronary artery disease involving the left main/three-vessel disease with indication for CABG following heart team conference - Life expectancy < 2 years - Severe chronic pulmonary disease (FEV1 < 30 % of predicted value) - Contraindication to dual anti-platelet therapy - Pregnancy - eGFR < 30 mL/min/1.73 m2 - In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first. - Severe valvular heart disease Primary endpoint Cohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization*), hospitalization for heart failure or incidence of malignant arrhythmias. *CCS class ≥ 2 and/or QoL score < 60. Same criteria used as for allocation to Cohort B Cohort B: SAQ Quality of Life Assessment after 6 months. Number of patients 1,560 (1200 in cohort A/360 in cohort B Follow up time Cohort A: 5 years Cohort B: 6 months

NCT ID: NCT03558295 Recruiting - Atrial Fibrillation Clinical Trials

CHAOS Registry Study

CHAOS
Start date: May 1, 2018
Phase:
Study type: Observational [Patient Registry]

INTRODUCTION: About 6-8% of patients undergoing PCI have an indication for long-term oral anticoagulants (OACs) due to various conditions such as atrial fibrillation (AF), mechanical heart valves, or venous thromboembolism. The addition of single or double antiplatelet therapy to OACs therapy results in an increase in bleeding complications (1-4). The standard of care of management in this patients, indicated by 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease (5), recommends the use of a triple therapy (Aspirin, clopidogrel and OAC) for 1-6 months (depending on the ischemic and hemorrhagic risk), then continue with double therapy only up to twelve month (Aspirin or clopidogrel and OAC) and after twelve months continue with the OAC only; the use of prasugrel or ticagrelor as part of triple therapy should be avoided (6). Only RELY study enrolled a small number of patients, less than one thousand, treated with dabigatran plus DAPT. Moreover, In the recent RCTs (WOEST(7), PIONEER AF-PCI study(8) and REDUAL-PCI(9)) only the double therapy (Aspirin or Clopidogrel/ticagrelor and DOAC) against triple therapy with warfarin was tested; and furthermore patients enrolled in RCTs represent only a small and not always representative sample of people treated in everyday clinical practice, who report a large burden of comorbidities and an older age. Randomized head to head comparison of warfarin and DOACs life-long (over 12 months from the PCI) have not been performed yet with clinical events as end points. AIMS: Aim of the present study is to describe the contemporary management of patients who underwent a PCI and have an indication to OAC for AF evaluating the different types of combination therapies used (triple therapy with warfarin or with DOAC, single anti-platelet therapy plus warfarin or DOAC) and their management in the first year after a PCI in a "real-life" setting. Secondary we would also evaluate the safety (in term of bleedings) and the efficacy (in term of ischemic and cardioembolic events) of the use of the different combination of single or double antiplatelet with OACs, in patients with coronary artery disease. MATERIALS AND METHODS: This is a retrospective, multicenter study including patients presenting with coronary artery disease (acute or stable setting) undergoing to PCI, in single or double antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel, aspirin and clopidogrel, aspirin and ticagrelor, aspirin and prasugrel) with an indication to anticoagulant therapy (warfarin, dabigatran, rivaroxaban, edoxaban). The different groups will be compared with a propensity score analysis with matching. Primary (efficacy) end-points: - A composite end points including death, myocardial infarction, stent thrombosis, revascularization stroke (MACE). - A composite end points including death, myocardial infarction, stent thrombosis, revascularization, stroke and BARC [Bleedings according to the Bleeding Academic Research Consortium] 2,3,5 (7,8): all events mutually exclusive (NACE). Secondary end-points: Individual components of NACE; Cardiac death; Stroke; Target vessel revascularization (TVR) and non TVR and the number of the revascularization.

NCT ID: NCT03558269 Recruiting - Clinical trials for Congenital Heart Disease

Autologous Umbilical Cord Blood Treatment of Neonate With CHD

Start date: February 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA). Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process. Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems

NCT ID: NCT03553810 Recruiting - Clinical trials for Hypertensive Heart Disease

Role of ARNi in Ventricular Remodeling in Hypertensive LVH

REVERSE-LVH
Start date: April 12, 2019
Phase: Phase 2
Study type: Interventional

In Singapore, hypertension is very common in the adult population. Hypertensive heart disease is a leading cause of heart failure and cardiovascular death. Current management relies primarily on achieving blood pressure targets. However, the optimal blood pressure goals are controversial and there are inherent difficulties in measuring blood pressure using external devices applied to peripheral arteries. As a result of (usually longstanding) hypertension, the heart thickens (i.e. hypertrophies) to maintain function. Ultimately, HF may occur due to long standing energy deficits, muscle injury/death and diffuse interstitial fibrosis (heart muscle scarring). In an ongoing study (REMODEL, ClinicalTrial.gov Identifier NCT02670031), we have been able to undertake preliminary analyses with respect to factors associated with the development of fibrosis. In this randomize controlled trial, we will be examining a novel therapy that has the potential to induce regression cardiac hypertrophy and fibrosis.

NCT ID: NCT03544424 Recruiting - Aging Clinical Trials

A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices

PATTErn
Start date: October 12, 2018
Phase:
Study type: Observational

An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)