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Hypertrophy clinical trials

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NCT ID: NCT00879060 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy

Start date: November 2007
Phase: Phase 4
Study type: Interventional

Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the leading cause of sudden cardiac death in young people and an important cause of heart failure symptoms and death at any age. In HCM, pathological remodeling of the left ventricle involving myocardial fibrosis is likely a major contributor to cardiac dysfunction and also a nidus for the generation of ventricular arrhythmias. Serum markers of collagen turnover have been shown to reliably reflect the magnitude of myocardial fibrosis in a variety of cardiovascular diseases. In addition, aldosterone antagonist drugs have been shown to decrease fibrous tissue formation in the myocardium in certain pathologic cardiovascular states in which aldosterone production is increased. In HCM, aldosterone production is up-regulated and has been implicated in the formation of myocardial fibrosis. Therefore, the specific aims of this proposal are to: 1. assess serum markers of collagen turnover at baseline and correlate these findings with a variety of clinical and morphologic disease parameters 2. examine the effects of a 12-month treatment with the aldosterone antagonist spironolactone on magnitude of fibrosis as measured by serum markers of collagen turnover as well as changes in clinical and morphologic disease parameters. 3. explore the effects of a 12-month treatment with aldosterone antagonist spironolactone on heart failure status, diastolic function, arrhythmic burden, and total LV mass and quantity of fibrosis by CMR. The results of this proposal will offer important insights into the clinical significance of myocardial fibrosis in this primary genetic cardiomyopathy. The demonstration that spironolactone decreases fibrosis and improves clinical course would provide the rational for a larger multicenter clinical trial evaluating this novel therapy for improving clinical outcome in patients with HCM.

NCT ID: NCT00875940 Completed - Clinical trials for Pulmonary Hypertension

Right Ventricular Hypertrophy and Pulmonary Hypertension: A Correlation Analysis

Start date: February 2008
Phase: N/A
Study type: Observational

The study hypothesis is that a quantitative index can be derived from Tc-99m myocardial perfusion scans that accurately identifies the presence of left ventricular hypertrophy and pulmonary hypertension. Echocardiography provides the reference standard.

NCT ID: NCT00827814 Completed - Clinical trials for Benign Prostatic Hyperplasia

Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction

Start date: June 2006
Phase: Phase 4
Study type: Interventional

Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and patients, and relief of bladder outlet obstruction reverses an increased bladder mass. Whether increased bladder mass is not only a consequence of bladder outlet obstruction but also a relevant risk factor for the progression of lower urinary tract symptoms associated with benign prostate hyperplasia cannot be decided due to a lack of appropriate data, most likely because bladder wall thickness is not routinely measured in clinical studies and/or routine clinical practice. Despite this lack of data, many urologists feel that increased bladder mass should be prevented or decreased to reduce the occurrence of serious complications. The possibility of using bladder wall thickness data as criteria for benign prostate hyperplasia intervention and as outcome criteria for benign prostate hyperplasia treatment has been proposed. Detrusor hypertrophy associated with bladder outlet obstruction can be imaged on suprapubic ultrasound, and bladder mass can be quantified from the evaluation of bladder wall thickness and bladder volume. Bladder wall hypertrophy has been found to be correlated with detrusor function. Independent studies have shown that surgical treatment of benign prostatic obstruction results in a significant decrease of bladder mass. Preliminary data suggest the possibility that medical treatment with alpha-adrenergic antagonists might also produce a reduction of bladder wall hypertrophy. The investigators assume that the prevention of benign prostate hyperplasia progression by alpha-adrenergic antagonists and 5 alpha reductase inhibitors may be result of bladder function protection. To our knowledge there have been no studies that evaluated the effects of a 5 alpha reductase inhibitors on bladder function. Therefore, the investigators plan to conduct a prospective trial evaluating the effects of 5 alpha reductase inhibitors on bladder function by the evaluation of bladder wall thickness and lower urinary tract symptoms.

NCT ID: NCT00821353 Completed - Atrial Fibrillation Clinical Trials

Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Start date: January 2009
Phase: Phase 3
Study type: Interventional

Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome. Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients. Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.

NCT ID: NCT00771394 Completed - Overactive Bladder Clinical Trials

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Start date: October 2008
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

NCT ID: NCT00754247 Completed - Keloid Clinical Trials

A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars

Start date: March 2006
Phase: Phase 4
Study type: Interventional

Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.

NCT ID: NCT00753233 Completed - Clinical trials for Hypertrophic Cardiomyopathy (HCM)

Identification of Risk Factors for Arrhythmia in Children and Adolescents With Hypertrophic Cardiomyopathy

Start date: September 5, 2008
Phase: N/A
Study type: Observational

This study will review medical information collected on children and adolescents with hypertrophic cardiomyopathy (HCM) to try to identify risk factors for arrhythmias (abnormal heart rhythms) in these patients and better guide the choice of treatment options for them. Arrhythmias arising from the ventricle (lower heart chamber) can cause dizziness, fainting or cardiac arrest. Predictors of arrhythmias in adult HCM patients may not apply to children and teenagers with HCM. Children and adolescents 21 years of age or younger who were diagnosed with HCM and evaluated in the National Heart Lung and Blood Institute's Cardiology Branch between 1977 and 2002 may be eligible for this study. Participants do not undergo any further testing or data gathering beyond a review of their medical records; only existing data previously collected for research purposes are used. Medical records are reviewed for age of the patient on admission to the NIH; family history of sudden death, fainting, exercise-induced low blood pressure, and results of tests on heart structure and function.

NCT ID: NCT00727025 Completed - Clinical trials for Breast Reconstruction

Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure

Start date: July 2005
Phase: N/A
Study type: Interventional

Purpose: The aims of this randomized clinical trial are: 1. to assess scar quality from the patient and surgeon perspectives 2. to assess patient comfort in the days immediately following surgery 3. to assess the time taken to complete closure in the operating room. 4. the financial benefit or cost for the institution of using Steri Strip S will also be estimated. Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus standard subcuticular sutures. The linear incisions will include the standard incision segments utilized for an inverted-T closure for bilateral breast reduction and the transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest. Our hypothesis is that incisions segments closed with Steri Strip S compared to standard subcuticular closure, will yield scars of better cosmetic quality, in shorter time to closure, with novice and expert surgeons, for both bilateral breast reduction and abdominoplasty surgical procedures.

NCT ID: NCT00718848 Completed - Clinical trials for End-stage Renal Disease

Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease

Start date: July 2008
Phase: N/A
Study type: Observational

Background: Recent data indicate that home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights per week) may have substantial cardiovascular benefits, including regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and blood pressure control. Nevertheless, this dialysis modality is only feasible in a highly-selected minority of ESRD patients, who can self-manage their dialysis treatment at home. In-centre nocturnal hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3 nights per week, represents an appealing and practical alternative. As this is a novel form of therapy, there has been no definitive study examining the cardiovascular impact of INHD to date. Objective: To determine the effects of INHD on LV mass, global and regional systolic and diastolic function, and other cardiovascular biomarkers in patients with ESRD. Hypothesis: Conversion from conventional hemodialysis to INHD is associated with favourable changes in cardiac structure and function in patients with ESRD. Rationale for Using Cardiac MRI: Cardiac magnetic resonance imaging (CMR) has emerged as the new gold standard for measuring LV mass, volume, global and regional myocardial function. Its accuracy and precision make it the imaging modality of choice for studying the small number of patients currently undergoing or awaiting INHD. Study Design and Population: This is a prospective cohort study of adult ESRD patients who are currently receiving conventional in-centre hemodialysis and will be converted to INHD. Patients will be managed as per standard clinical practice (e.g. blood pressure, anemia management) established for the INHD program, and no therapeutic intervention will be performed as part of this study. All eligible patients will undergo two serial CMR examinations: within 2 weeks prior to conversion and at 52 weeks following conversion to INHD. We also plan to recruit a population of control patients who have elected to remain on conventional HD. These individuals will be asked to undergo the same set of investigations at baseline and 12 months thereafter. Outcome: The primary endpoints are the temporal changes in LV mass and size, global and regional diastolic and systolic function at 52 weeks after conversion to INHD, as measured by cardiac MRI. Secondary endpoints include changes in myocardial tissue characteristics, blood pressure, mineral metabolic parameters, anemia control, serum troponin, norepinephrine, brain natriuretic peptide, markers of inflammation and quality of life. Significance: The provision of an enhanced dialysis regimen has emerged as the most promising avenue through which to modify the dismal cardiovascular outcomes in patients receiving chronic hemodialysis. INHD represents a means of administering such therapy to a broad spectrum of dialysis patients for whom home therapies would not be feasible. The proposed study will be the first to precisely define the cardiac impact of INHD using CMR. The findings may justify large randomized controlled trials evaluating clinical outcomes. If INHD is proven to be effective, it will have a major impact on the management and outcome of many patients with ESRD in Canada.

NCT ID: NCT00706966 Completed - Prostate Cancer Clinical Trials

MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer

Start date: June 2005
Phase: N/A
Study type: Interventional

RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer. PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.