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Hypertrophy clinical trials

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NCT ID: NCT04905173 Withdrawn - Clinical trials for Hypertrophic Cardiomyopathy

Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy

Start date: November 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of squat-to-stand maneuver in eliciting left ventricular outflow gradients in patients with Hypertrophic Cardiomyopathy (HCM) compared to Valsalva, amyl nitrite inhalation, and exercise stress echocardiogram (ESE).

NCT ID: NCT04302337 Withdrawn - Adenoid Hypertrophy Clinical Trials

Conventional Curettage Adenoidectomy vs Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

This prospective study is designed to compare short and long term results of conventional cold curettage adenoidectomy in children performed without doing any endoscopic or mirror examination before ending the operation versus when combined with transoral endoscopic residue ablation using a wand.

NCT ID: NCT04256343 Withdrawn - Hypertrophy Clinical Trials

D2O Dosing Strategies to Assess Muscle Protein Synthesis

D2O-MPS
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

Skeletal muscle mass is regulated by the balance of muscle protein synthesis (MPS) and muscle protein breakdown (MPB). MPS is sensitive to exogenous stimuli, particularly exercise and protein ingestion. Much of what the investigators currently know about the impact of exercise and protein feeding on MPS has been derived from acute stable isotopic tracers in a controlled laboratory setting. However, recently, the field of skeletal muscle protein metabolism has moved towards the use of deuterium oxide (deuterated water (D2O)) to measure MPS. The ease of administration and the scope to measure turnover in a range of substrates whilst negating the need for strictly controlled laboratory settings makes D2O the ideal candidate to provide a more holistic view of in vivo skeletal muscle metabolism.

NCT ID: NCT03315832 Withdrawn - Clinical trials for Aortic Valve Stenosis

Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study

ARISTOTE
Start date: January 2, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter aortic valve replacement [TAVR]) in severe AS, as soon as symptoms or left ventricular (LV) dysfunction occur, in order to improve clinical outcome and achieve LV mass (LVM) regression. The highest amount of LVM regression is obtained during the first year. Nevertheless, there is heterogeneity in LV remodeling and residual LV hypertrophy is associated with poorer postoperative improvement in cardiac function and morphology. Incomplete regression of LV hypertrophy at 12 months after SAVR is a powerful predictor of adverse outcome. Yet, the use of specific pharmacological therapy to improve postoperative LVM regression could be an appealing therapeutic option after aortic valve intervention. Renin-angiotensin-aldosterone system blockers (RAASb) and more particularly angiotensin-II receptor blockers (ARBs) are efficient in reducing LVM in hypertensive patients, as emphasized by several meta-analyses. In addition, ARBs improve myocardial relaxation, diastolic function, decreased hypertrophy and may have anti-fibrotic effects. In a recent retrospective study from our group, RAASb prescription after SAVR was associated with increased survival, but confirmation through a randomized trial is mandatory. In a prospective randomized single-center study, the use of candesartan was associated both with LV and LA remodeling as compared to the conventional management. Nevertheless, these results are based on echocardiographic data, which is not the gold standard for the assessment cardiac remodeling, and no placebo or active comparator was tested to control the impact of ARBs in these patients. The primary objective of this Phase II study is to investigate the efficacy of valsartan, introduced postoperatively, as compared to placebo, on 1-year changes in indexed LVM, as assessed by CMR, in patients undergoing aortic valve intervention (SAVR or TAVR) for AS. The secondary objectives are to compare the efficacy of valsartan vs. placebo in terms of one-year changes (difference from baseline) in cardiac function and in cardiac morphology, one-year exercise capacity and one-year changes in biomarkers related to cardiac function. In addition, the assessment of the safety of valsartan will also be considered as secondary objective. The ARISTOTE trial is a multicenter prospective phase II, randomized, double-blind study including patients with the diagnosis of severe AS and indication for valve intervention. The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist. Patients will be randomized between 2 groups (valsartan versus placebo) and the treatment will be initiated (80 mg daily) at 5±4 days following aortic valve intervention. The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group. The patients will be cautiously monitored and any adverse events will be collected. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study. The tolerance will be regularly assessed and dose adjusted according to a pre-specified algorithm.

NCT ID: NCT02961114 Withdrawn - Nocturia Clinical Trials

Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy

SVF-BPN
Start date: November 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Benign prostate hypertrophy (BPH) and inflammation are common non-cancerous enlargement of the prostate, which result in urinary interference and incomplete drainage of the bladder. Compression of the urethra is common cause of such resistance of full draining, and may over time result in progressive hypertrophy, instability, urgency, nocturia and weakness of the bladder musculature. Prostatic growth frequently begins in the 30s, and it is estimated that 50% of all males have benign enlargement leading to 75% by age 80. BPH and low grade inflammation is one of the ten most prominent and costly disorders in males over 50. Urinary tract symptoms are divided into issues of storage, voiding, and post-void symptoms can be associated with bladder outlet obstruction (BOO). This study utilizes isolation of adipose-derived stem/stromal cellular stromal vascular fraction (AD-cSVF) deployed as an IV suspension in sterile Normal Saline (500cc). Due to the anti-inflammatory and immunomodulatory effects common to AD-cSVF are tested in relief of the inflammatory elements and the concurrent hypertrophy in BPH. Early pilot use has suggested a positive effect on these issues, and have relieved much of the incomplete voiding, pain, nocturia, delay in starting/stopping urination, and increased urgency and frequency. Lipoharvesting of Adipose-Derived tissue stromal vascular fraction (AD-tSVF) is now a common closed access to subdermal adipose stromal/stem cell population consisting of both stem and stromal cells, each of which are felt to contribute a wide variety of effects and potentials. Closed, sterile isolation of the AD-cSVF is possible with advent of closed systems to enzymatically release these cells from the actual matrix (scaffolding) within the adipose tissue complex (ATC). This group of largely un-designated cell population is isolated and concentrated via a standard gradient layer separation by centrifugation. This cellular isolate is then suspended in an IV of 500 cc Normal Saline and reintroduced to the patient. This study is examining the clinical safety and efficacy of this approach, as well as tracking the duration of effects and establish a therapeutic interval.

NCT ID: NCT02711605 Withdrawn - Gynecomastia Clinical Trials

UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)

Start date: March 13, 2016
Phase: N/A
Study type: Interventional

Male volunteers who suffer from Pseudogynecomastia and seek noninvasive breast fat reduction will be enrolled into two arms to receive three biweekly UltraShape treatments.

NCT ID: NCT02655211 Withdrawn - Hypertrophic Scars Clinical Trials

Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial

LIBERTI
Start date: December 2016
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2) laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care.

NCT ID: NCT02546076 Withdrawn - Keloid Clinical Trials

Comparison of Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars

KELOID
Start date: May 2016
Phase: Phase 2
Study type: Interventional

Skin injuries due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars. The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars. The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent to laser with heat/coagulation in terms of scars volume reduction, while the secondary hypothesis is that ablative fractional laser without heat/coagulation is superior in terms of post-operative erythema and hypopigmentation reduction.

NCT ID: NCT02431221 Withdrawn - Clinical trials for Hypertrophic Cardiomyopathy

Efficacy, Safety, and Tolerability of Perhexiline in Subjects With Hypertrophic Cardiomyopathy and Heart Failure

Start date: n/a
Phase: Phase 3
Study type: Interventional

A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure

NCT ID: NCT02204696 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea

Start date: December 2010
Phase: N/A
Study type: Observational

The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft palate and uvula length.