Hypertension

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Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients

Trial phase: 
Phase IV
Recruitment status: 
Completed

The primary objective of this study is to observe if Sibutramine is effective in improving the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to document the effects of Sibutramine on heart rate variability and 24-h arterial pressure values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea (OSA).

Background information
Trial ID: 
NCT00729963
Other unique IDs: 
CER911
Official title: 

Efficacy of Sibutramine-Induced Weight Loss vs. Continuous Positive Airway Pressure (CPAP) in the Treatment of Obese Patients With Obstructive Sleep Apnea

Detailed description: 

 

Number to be enrolled: 
45 patients

The Efficacy, Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients

Nifedipine and barnidipine act as calcium channel blockers, and are widely prescribed for pressure control of prehypertension and stage 1 hypertension. CYP3A4 is responsible for the metabolism of nifedipine and nifedipine, while the contribution of CYP3A5 remains ambiguous. This study is aimed to analyze the association between antihypertensive effects of nifedipine as well as barnidipine and single nucleotide polymorphisms of CYP3A4, CYP3A5 and calcium channels.

Background information
Other unique IDs: 
941227

Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation

Ginseng has been used for many years in a wide array of anecdotal medicinal properties. Animal and limited clinical research points to the vascular effects of Korean Red Ginseng (KRG). The present project aims to assess the efficacy of KRG and contribution of its factionated components on various indices of vascular function in healthy individuals. Our primary objective is to compare the acute effects of KRG and placebo on endothelial function. Moreover, our secondary objective is to evaluate the effect of isolated KRG factions on arterial stiffness, blood pressure and vasoactive markers. We hypothesize that (1) consumption of KRG will cause an improvement in endothelial function in healthy individuals, as compared to placebo; (2) consumption of KRG will cause an improvement in arterial stiffness and blood pressure in healthy individuals, as compared to placebo; (3) the ginsenoside faction of KRG is primarily responsible for the anticipated vascular effects.

Background information
Other unique IDs: 
118328

The Effect of Acupuncture on Blood Pressure and Heart Rate Variability (HRV)

Trial phase: 
Phase I
Recruitment status: 
Recruiting

This research is designed to study the effects of needle acupuncture on blood pressure and HRV by stimulating certain acupuncture points and meridians.

Background information
Trial ID: 
NCT00724763
Other unique IDs: 
RD0609080136
Official title: 

The Effect of Acupuncture on Blood Pressure and HRV

Detailed description: 

Outcome measurements include blood pressure and heart rate variability.

Number to be enrolled: 
40 patients
Acronym: 
Acupuncture

Free Fatty Acid-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects

Recruitment status: 
Recruiting

Our recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs) increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory markers in subjects with and without diabetes. The effects of FFA on blood pressure and vasculature have not been fully investigated. We hypothesize that observed changes in blood pressure are the result of acute endothelial dysfunction, and/or increased activation of the autonomic nervous system. In addition, it is not known if increased FFAs by repeated oral fat load results in similar blood pressure than intravenous lipid infusion. Accordingly, we propose: 1) a systematic evaluation of the effects of increasing FFA levels on blood pressure and endothelial (vascular) function, and 2) determine the effects of comparable increases in FFA concentration via intravenous infusion of Intralipid or by repeated oral fat load on blood pressure, insulin resistance and endothelial dysfunction in obese subjects. This study has two parts. In the first part of the study, a group of 12 obese and 12 lean nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 3 occasions. Research subjects will receive, in random order, a 24-hour intravenous (IV) infusion of Intralipid 20ml/hr (a fat solution), 24-hour IV infusion of normal saline, or an oral liquid fat diet every 4 hours for 24-hours. The effect of increased FFAs on blood pressure and endothelial (vascular) function via intravenous infusion versus oral fat load therapy will be assessed. The fat load (IV vs. oral) that causes the largest effect on blood pressure and endothelial function will be used in the second portion of the protocol. In the second part of the study, a group of 36 obese normotensive (diabetic and nondiabetic) subjects will be admitted to the GCRC on 2 separate occasions for a randomized control trial. Study subjects will first be admitted to receive a fat load and then they will be randomly placed on either salsalate, carvedilol, or placebo for 6 weeks. After the 6-week intervention period, the subjects will be re-admitted to the GCRC to see if the intervention has any effect on improving blood pressure or endothelial function.

Background information
Trial ID: 
NCT00721617
Other unique IDs: 
e9277
Official title: 

Free Fatty Acids-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects

Detailed description: 

 

Number to be enrolled: 
48 patients
Acronym: 
FFAADA

Aliskiren and Muscle Sympathetic Nerve Activity

Trial phase: 
Phase IV
Recruitment status: 
Not yet recruiting

The central hypothesis of this project is that Aliskiren causes a substantial decrease in MSNA in hypertensive patients with CKD.

Background information
Trial ID: 
NCT00719316
Other unique IDs: 
NL19926.041.07
Official title: 

Effect of Aliskiren on Muscle Sympathetic Nerve Activity (MSNA) in Hypertensive Patients With Chronic Kidney Disease

Detailed description: 

Cardiovascular (CV) morbidity and mortality are frequently occurring problems in chronic kidney disease (CKD) patients. Apart from the so called traditional risk factors, also risk factors more or less specific to CKD contribute in the pathogenesis of these problems. There is strong evidence that the sympathetic hyperactivity, which often characterizes CKD, is one such factor. Previously, we have shown that angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) reduce but not normalize this sympathetic hyperactivity.

Number to be enrolled: 
25 patients
Acronym: 
MSNA

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.

Background information
Other unique IDs: 
NHMRC-571281

Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients

Trial phase: 
Phase III
Recruitment status: 
Terminated

The study consists of a 12 week run-in period when all subjects are stabilized on a single dose of Avalide (300 mg/12.5 mg or 300mg/25mg dose) per day. After this 12 week run-in ends, subjects will be randomly assigned to start the addition of either Adalat XL or Tiazac XC for 18 weeks of treatment. Subjects will have a 1 in 2 chance of receiving the study drug Adalat XL and a 1 in 2 chance of receiving the drug Tiazac XC. An end of treatment visit will be done 18 weeks after start of study drug. The expected duration of the study is 30 weeks. The purpose of this study is to compare the change in proteinuria, through a urine test, while taking study drug until high blood pressure (BP) is reduced to near normal levels in study subjects with diabetic nephropathy and hypertension.

Background information
Trial ID: 
NCT00713011
Other unique IDs: 
12716
CARDINAL
Official title: 

Randomized Open-Label 2-Arm Parallel Design Comparator Study of the Effect of Adalat® XL® Compared to Diltiazem on Proteinuria and Blood Pressure in Patients With Diabetes and Mild to Moderate Hypertension When Used as an Add on to Avalide®

Detailed description: 

 

Number to be enrolled: 
1 patients

Device Based Therapy in Hypertension Extension Trial

Recruitment status: 
Active, not recruiting

This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up period (4-months or longer). The information obtained in this trial is intended to support regulatory approvals and market release of this therapy.

Background information
Trial ID: 
NCT00710294
Other unique IDs: 
360007-001
Official title: 

DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study

Detailed description: 

This extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under the long term provisions of the DEBuT-HT study to describe and analyze the changes in ongoing drug treatment, the programming parameters of the implanted active device and any occurring adverse events over a period of up to 13 months after implant surgery in the DEBuT-HT trial. Annual follow-ups of up to five years are planned subsequently to the 13-month follow-up period.

Number to be enrolled: 
50 patients
Acronym: 
DEBuT-HET

Device Based Therapy in Hypertension Trial

Recruitment status: 
Active, not recruiting

The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.

Background information
Trial ID: 
NCT00710190
Other unique IDs: 
360004-001
Official title: 

A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

Detailed description: 

The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension TherapyT in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients will be carefully assessed prior to receiving a permanently implanted Rheos System. Once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. The Rheos System will be programmed "ON" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations.

Number to be enrolled: 
45 patients
Acronym: 
DEBuT-HT
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