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NCT ID: NCT02002585 Recruiting - Clinical trials for Arterial Hypertension

Renal Protection Using Sympathetic Denervation in Patients With Chronic Kidney Disease

KPS
Start date: November 2013
Phase: Phase 2
Study type: Interventional

Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Renal denervation is a modern endovascular method used to treat resistant hypertension. The method is being extended to other groups of patients, where the sympathetic tone is increased beyond resistant hypertension. Because of the character of the disease, we hypothesize that renal denervation can reduce or prevent progressive deterioration of kidney functions in this patient population. The aim of this clinical study is to show that renal denervation has protective effects on the progression of chronic renal insufficiency.

NCT ID: NCT01997645 Recruiting - Anal Fistula Clinical Trials

Surgical Treatment of High Perianal Fistulas

LIFTRAF
Start date: November 2013
Phase: N/A
Study type: Interventional

Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously. Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review. Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%). The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.

NCT ID: NCT01980134 Recruiting - Adenoma Clinical Trials

The MORDIS Study Clinical Investigational Plan

MORDIS
Start date: December 2013
Phase: N/A
Study type: Observational

To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even left in-situ) without adverse clinical impact.

NCT ID: NCT01922609 Recruiting - Clinical trials for Carotid Occlusion Intolerance

Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.

Start date: May 2013
Phase: N/A
Study type: Observational

The aim of this observational pilot study is to determine whether intolerance of carotid occlusion during carotid artery stenting can be predicted with preprocedural transcranial Doppler evaluation.

NCT ID: NCT01877746 Recruiting - Clinical trials for Inflammatory Cardiomyopathy

CZECH-ICIT (CZECH Inflammatory Cardiomyopathy Immunosuppression Trial)

Start date: January 2013
Phase: Phase 3
Study type: Interventional

The aim of this study is to compare the effect of combined immunosuppressive therapy given on the top standard medical therapy of chronic heart failure according to current guidelines with standard medical therapy of chronic heart failure alone in patients with infammatory cardiomyopathy (ICM). Suitable subjects are characterized by EMB established presence of myocardial inflammation / negative polymerase chain reaction assay (PCR) findings of cardiotropic infectious agents and with varying duration of heart failure symptoms and left ventricular (LV) systolic dysfunction (phase A). Further, to compare the effect of two regimens of combined immunosuppressive therapy in these patients with ICM (phase B).

NCT ID: NCT01870310 Recruiting - Heart Failure Clinical Trials

Renal Denervation in Patients With Heart Failure and Severe Left Ventricular Dysfunction.

Start date: June 2012
Phase: N/A
Study type: Interventional

It is a randomized prospective controlled study evaluating the effect of transcatheter renal denervation on the clinical status of patients with chronic heart failure and its safety procedures. The working hypothesis of the study is that by performing transcatheter renal denervation in patients with chronic heart failure and severe left ventricular systolic dysfunction there will a resultant reduction in the renal sympathetic activation which in turn will reduce the number of hospitalizations and deaths from heart failure.

NCT ID: NCT01865591 Recruiting - Clinical trials for Uncontrolled Hypertension

Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

SoundITV
Start date: April 2012
Phase: Phase 0
Study type: Interventional

The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.

NCT ID: NCT01812993 Recruiting - Ischemic Stroke Clinical Trials

Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea

Reverse-STEAL
Start date: March 2013
Phase: Phase 2
Study type: Interventional

Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce. Several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled randomized sequential phase studies currently exist that aim to establish the efficacy of early non-invasive ventilation in AIS patients. The main hypothesis for this study is that early non-invasive ventilation with automated bilevel positive airway pressure (auto-BPAP) positively affects short-term clinical outcomes in AIS patients. This is a multicenter, prospective, randomized, controlled, third rater-blinded, parallel-group trial. Patients with AIS with proximal arterial obstruction and clinically suspected sleep apnea will be randomized to standard or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and nocturnal sleep. Patients will undergo cardiorespiratory polygraphy between day 3 and 5 to assess sleep apnea. The primary endpoint is any early neurological improvement on the NIHSS at 72 hours from randomization. Safety, tolerability, short-term and 3 months functional outcomes are assessed as secondary endpoints by un-blinded and blinded observers respectively. This study will provide data to power a subsequent phase III study.

NCT ID: NCT01810224 Recruiting - Clinical trials for Coronary Artery Disease

Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial

GRAFFITI
Start date: March 2013
Phase: Phase 4
Study type: Interventional

This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.

NCT ID: NCT01773512 Recruiting - Clinical trials for Coronary Artery Disease

The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques

PREDICT
Start date: June 2012
Phase: Phase 4
Study type: Interventional

- The prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques. - Detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel reconstruction. - Prediction of changes in coronary arteries based on changes in non-invasive examinations. - Examination of WSS influence on atherosclerosis development and changes of WSS during lipid lowering therapy.