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Hypertrophy clinical trials

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NCT ID: NCT05302271 Recruiting - Cardiomyopathies Clinical Trials

Phase IA Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia

Start date: February 22, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and preliminary efficacy of AAVrh.10hFXN to treat the cardiomyopathy associated with Friedreich's ataxia (FA). AAVrh.10hFXN is a serotype rh.10 adeno-associated virus gene transfer vector coding for Frataxin (FXN). The drug is administered intravenously. This is a phase 1, open label, dose escalation study with a total of 10 participants.

NCT ID: NCT05257772 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Electromechanically Optimised Right Ventricular Pacing In Hypertrophic Cardiomyopathy (EMORI-HCM)

EMORI-HCM
Start date: March 14, 2022
Phase: N/A
Study type: Interventional

Hypertrophic Obstructive Cardiomyopathy (HOCM) is an inherited cardiac condition which causes the heart muscle to become abnormally thick causing obstruction of blood flow in the heart. This causes debilitating symptoms including shortness of breath, blackouts and chest pain. Current treatments are not ideal as the medication is often poorly tolerated or ineffective. People with HOCM can often have an Implantable Cardioverter Defibrillator (ICD) to shock them out of dangerous arrhythmias. ICD's can also be used as pacemakers and are a promising treatment option, since they can alter the sequence of the heart muscle contraction thereby relieving the obstruction to the blood flow, making it easier for the heart to pump. The study will recruit patients who already have an ICD/pacemaker or who are scheduled to have an ICD / pacemaker implanted. For patients who are due to have a device implanted high precision haemodynamic, echocardiographic and electrical measurement techniques will be used to assess whether adjusting the position of the pacing lead (at the time of implant) can bring about changes in LVOT gradient and blood pressure. These patients with a new device and also patients who already have a device in situ will then go on to have atrioventricular delay (AV Delay) optimisation so we can assess what the optimum AV delay should be programmed at in order to bring about the most improvement in LVOT gradient and blood pressure. Patients will then be recruited into a medium term double blinded randomised crossover study. They will have optimum RV pacing settings turned on for 3 months. They will then return and be crossed over and have optimum RV pacing turned off for a further 3 months. The primary outcome will be to see if optimum RV pacing being turned on is effective in improving symptoms and quality of life.

NCT ID: NCT05233891 Recruiting - Breast Cancer Clinical Trials

Validation of Scales in Reconstructive Breast Surgery

ValPlast
Start date: June 21, 2021
Phase:
Study type: Observational

The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.

NCT ID: NCT05195710 Recruiting - Metastases Clinical Trials

Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases

Start date: November 16, 2022
Phase: Phase 1
Study type: Interventional

A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.

NCT ID: NCT05182658 Recruiting - Heart Failure Clinical Trials

Empagliflozin in Hypertrophic Cardiomyopathy

EMPA-REPAIR
Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

The proposed intervention will be administration of empagliflozin at a standard dose of 10 mg daily for a period of 12 months. Patients with diagnosed diabetes will be excluded from the study. Patients (n = 250) will be randomized in a double-blind fashion to empagliflozin or placebo group. The primary endpoint of the study will be the change in peak oxygen uptake (VO2 max) measured in a cardiopulmonary exercise test. VO2max is an objective indicator of physical performance and will be evaluated before and after empagliflozin or placebo treatment.

NCT ID: NCT05179668 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

SGLT2 Inhibition in Hemodialysis

DAPA-HD
Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

The study is designed as a prospective randomized, controlled, double-blinded phase II trial to examine the effect of the SGLT2 inhibitor dapagliflozin, in comparison with placebo on cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy with hemodialysis. The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging. Null and alternative hypotheses: H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo. H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.

NCT ID: NCT05108272 Recruiting - Hypertrophic Scar Clinical Trials

Comparison of Cosmetic and Functional Outcome of Silicone Sheeting and Micro-needling on Hypertrophic Scars

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Hypertrophic scars and keloids are frequently encountered in plastic surgery OPD. due to any reason, the normal wound healing is impaired, hypertrophic scars or keloids occur. These are thickened, wide and raised scars. Many treatment options are presented over time, but most of the treatments remain insufficient. Treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. In this Study outcomes of treatment with silicone sheeting and microneedling will be compaired.

NCT ID: NCT05073094 Recruiting - Clinical trials for Hypertrophic Obstructive Cardiomyopathy

Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Start date: October 6, 2021
Phase: Phase 4
Study type: Interventional

Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications. Several randomized-controlled studies and meta-analysis showed that esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery as well as enhances postoperative cardiac performance. No studies assessed the influence of esmolol in patients with hypertrophic obstructive cardiomyopathy undergoing cardiac surgery.

NCT ID: NCT05068622 Recruiting - Clinical trials for Respiratory Complication

Gastric Tube in Pyloric Stenosis

SONPYL
Start date: February 15, 2021
Phase:
Study type: Observational

Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.

NCT ID: NCT05023824 Recruiting - Clinical trials for Prostatic Hyperplasia

Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH

Start date: December 8, 2020
Phase: Phase 3
Study type: Interventional

The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.