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Hypercholesterolemia clinical trials

View clinical trials related to Hypercholesterolemia.

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NCT ID: NCT03161327 Completed - Hypertension Clinical Trials

Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease

Start date: July 15, 2017
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden, currently estimated to be greater than cancer and heart disease. Older age (> 65 years), smoking, diabetes and kidney diseases are some risk factors associated with PAD and are known to have increased morbidity and mortality.Early detection is critical for mitigating PAD progression. Ankle-brachial index (ABI) testing is recommended by the US Preventative Services Task Force as an affordable and effective screening tool for evaluating PAD risk. QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital device that is used as a screening tool to measure ABI of patients at risk of PAD. This single center prospective clinical trial will evaluate the sensitivity and specificity of digital ABI in detecting PAD using color Doppler ultrasound and 'gold standard' angiography as reference. Specifically in patient undergoing dialysis and who cannot undergo ABI using pressure cuffs dialysis grafts/ fistulae in the arms, we will evaluate the value of digital ABI in detecting PAD.

NCT ID: NCT03156621 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

ODYSSEY HoFH
Start date: October 3, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: - To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein [Apo] A-1 and B, non-high-density lipoprotein cholesterol [non-HDL-C], total-cholesterol [TC], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides [TG]) in participants with HoFH - To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH - To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH - To assess the potential development of anti-drug (alirocumab) antibodies

NCT ID: NCT03134235 Completed - Hypertension Clinical Trials

Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors

Start date: January 3, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.

NCT ID: NCT03110848 Completed - Clinical trials for Hypercholesterolemia

Effects of Atorvastatin in Graves' Orbitopathy (GO)

STAGO
Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease (GD), being observed in ~25% of patients. Besides genetic and demographical variables, risk factors associated with the development of GO in GD patients are known to be inadequate control of hyperthyroidism, radioiodine treatment, and smoking. In a large retrospective study conducted in more than 8,000 individuals with GD it was observed that treatment with 3-hydroxy-3-methylglutaryl-coenzyme reductase inhibitors, better known as statins, is associated with a ~40% reduced risk of developing GO in GD patients. The findings were interpreted as the consequence of the anti-inflammatory action of statins, being GO notoriously an autoimmune, inflammatory conditions. Statins are widely used for the treatment of hypercholesterolemia, for which they are quite effective. The possibility that their "protective" effect in terms of GO development in GD patients, as observed by Stein et al., was simply due to their hypolipemic actions was not considered. To evaluate the possibility that the findings reflected lowering of cholesterol rather than a direct anti-inflammatory effect of statins a prospective, observational study to assess the association between GO and high cholesterol levels and/or the relationship between the degree and/or activity of GO and hypercholesterolemia is ongoing. Preliminary findings suggest that GO is more severe and active in patients with high cholesterol levels. On the basis of these observations, the present randomized clinical trial was designed to be performed in hypercholesterolemic patients with GD and moderate-to-severe and active GO, aimed at investigating if lowering of cholesterol levels with statins is associated with a better outcome of GO.

NCT ID: NCT03110250 Completed - Atherosclerosis Clinical Trials

Familial Hypercholesterolemia in Turkey (A-HIT2)

A-HIT2
Start date: February 26, 2017
Phase: N/A
Study type: Observational

A-HIT2, is also designed as a National FH registry. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution.[14] Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology.

NCT ID: NCT03084822 Completed - Obesity Clinical Trials

Cardiovascular Health Promotion Among African-Americans by FAITH!

FAITH!
Start date: March 2016
Phase: N/A
Study type: Interventional

Given the importance of healthy lifestyle practices to cardiovascular disease (CVD) prevention and the utility of church-based interventions in African-American adults, the investigators developed a theory-informed, strategically-planned, health and wellness intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN) churches with predominately African-American congregations. The objective of the study was to partner with churches to implement a multi-component, health education program through the use of core educational sessions delivered through a digital-application accessible on demand via interactive access on computer tablets and the Internet. The overarching goal was to increase the awareness and critical importance of healthy lifestyles for CVD prevention and provide support for behavior change.

NCT ID: NCT03074630 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dapagliflozin and Cholesterol Metabolism in Type 2 Diabetes (DM2)

DICE
Start date: May 2016
Phase: Phase 4
Study type: Interventional

Objective: To investigate the effect of 5 weeks dapagliflozin 10 mg once daily treatment on glucose and lipid fluxes in patients with type 2 diabetes. Study design: Single center single arm (mechanistic) intervention trial. Study Population: Male or postmenopausal female patients with type 2 diabetes BMI > 25 kg/m2and more than 12 weeks a stable dose of metformin treatment > 1500mg, HbA1C ≥6.5% - <8.5%, Fasting Plasma Glucose (FPG) <13.2 mmol/l, LDL cholesterol >2.5 mmol/l, willing to switch to rosuvastatin 10mg once daily for 4 weeks, and then receive 10 mg dapagliflozin once daily orally, for 5 weeks. Treatment: After a statin washout fase of 4 weeks, baseline cholesterol synthesis will be measured (2H3 Leucine, 2H2O deuterated water). Then, treatment with rosuvastatin 10mg for 4 weeks will be initiated after which, patients will undergo glucose (2H2enriched glucose) and lipid flux (2H3 Leucine, 2H2O deuterated water and oral 1,2,3,4-13C16 - palmitate enrichment measurements) followed by 5 weeks treatment with dapagliflozin 10mg once daily. In the final week glucose/lipid flux measurements will be repeated. Sample Size: 12 DM2 subjects. Outcome measures: The primary endpoint is effect of 5 weeks Sodium-Glucose Linked co-transporter (SGLT) 2 inhibition on LDL cholesterol synthesis in patients with DM2. Secondary endpoints are effect of SGLT2 inhibition on triglyceride and cholesterol fluxes as well as (hepatic and peripheral) insulin sensitivity and energy expenditure. Finally, effect of SGLT2 inhibition on dietary intake, liver fat content (MRI liver) and fecal microbiome will be studied at these timepoints.

NCT ID: NCT03067441 Completed - Clinical trials for Hypercholesterolemia

Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)

Start date: February 3, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

NCT ID: NCT03065491 Completed - Clinical trials for Hypercholesterolemia

Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function

Start date: November 15, 2016
Phase: N/A
Study type: Interventional

A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.

NCT ID: NCT03060577 Completed - Type2 Diabetes Clinical Trials

An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

ORION-3
Start date: April 27, 2017
Phase: Phase 2
Study type: Interventional

This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).