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NCT ID: NCT01370096 Terminated - Clinical trials for Pulmonary Hypertension

Vasopressin and Inhaled Prostacyclin in Pediatric Pulmonary Hypertension

Start date: February 2012
Phase: Phase 2
Study type: Interventional

To diagnose pulmonary hypertension, children have a cardiac catheterization to check the blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure in their lungs. The right ventricle of the heart has to do more work to pump against this higher pressure. The investigators do not know the best medicine(s) to help children with pulmonary hypertension when their right ventricles fail. The purpose of the study is to look at the effects of two different medicines on the blood pressure in the lungs of a child with pulmonary hypertension. The investigators hope to then be able to choose the best medicine for children with pulmonary hypertension and right ventricular failure. The first medicine is called vasopressin. It is a hormone that your body makes on its own. The investigators will be giving it through an intravenous infusion. The investigators think that vasopressin works differently in different parts of your body. The investigators are looking to see the different effects that vasopressin has in the lungs compared to the rest of the body. The second medicine is called prostacyclin and is something that your body also makes by itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary hypertension as it decreases pressure in the blood vessels. In the catheterization laboratory, patients breathe in this medicine to measure specific changes in the blood pressure in their lungs.

NCT ID: NCT01368536 Terminated - Hypertension Clinical Trials

Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes

VALENCIA
Start date: May 2011
Phase: Phase 4
Study type: Interventional

This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.

NCT ID: NCT01357746 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Measuring Blood Pressure in the Lung Circulation With Sonar Technology (Echo-Doppler)

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This is a non-invasive study using a standard doppler echocardiographic transducer which records signals emanating from the lungs (TPD). These signals are caused by pulsation of blood vessels in the lung tissue. The innovations in this study are: 1. The software processing of the reflected ultra-sound waves from the lung rendering a reproducible, clear and strong signal in sync with the cardiac cycle, 2. The observation based on pilot studies that blowing hard against resistance during recording (something called a Valsalva maneuver), affects the lung signal weakening it and even obliterating it as the pressure rises. The investigators hypothesis is that since the signal comes from the blood vessels in the lung, the pressure at which the recorded signal disappears during the Valsalva maneuver represents the blood pressure in the lungs.

NCT ID: NCT01349114 Terminated - Hypertension Clinical Trials

Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Start date: June 2011
Phase: Phase 4
Study type: Interventional

The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

NCT ID: NCT01332331 Terminated - Clinical trials for Hypertension, Pulmonary

Efficacy and Safety of Ambrisentan in Children 8-18yrs

Start date: January 4, 2011
Phase: Phase 2
Study type: Interventional

A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An additional objective is to determine the ambrisentan population pharmacokinetics in the paediatric population. The study will include a screening/baseline period and a treatment period. The treatment period will be 24 weeks or until the subject's clinical condition deteriorates to the point that alternative/additional treatment is necessary. Patients who participate in the study and in whom continued treatment with ambrisentan is desired will be eligible to enrol into a long term follow-up study. The primary comparison will be the safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH population The secondary comparison will be the change from baseline for the efficacy parameters between the two treatment groups.

NCT ID: NCT01319045 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease

Start date: June 2011
Phase: N/A
Study type: Interventional

Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in patients with congenital heart disease. Historically these patients suffered significant morbidity and mortality due to a lack of effective therapies. More recently, advanced therapies which target the mechanisms underlying the development and progression of PAH have been introduced into clinical care. Oral, intravenous, subcutaneous, and inhaled therapies are all available for the treatment of PAH. Patients with PAH are first treated with oral agents (including sildenafil and bosentan). However, if these agents fail to achieve the desired effect for the patient, intravenous or inhaled therapies may be initiated. Combination therapy with multiple agents is common in routine clinical care. However, the most efficacious therapeutic regimen has yet to be delineated. The present study seeks to evaluate the efficacy of one specific regimen: iloprost, an inhaled prostacyclin derivative, used in combination with oral therapy (sildenafil and/or bosentan). Iloprost has been approved by the FDA for use in this patient population. Adults with PAH already receiving oral therapy will be invited to participate in this study. Iloprost will be added to their current therapeutic regimen for a period of three months, with pre- and post-treatment assessments. These will include a cardiopulmonary exercise test, BNP (a blood test), six minute walking distance, and a quality of life questionnaire.

NCT ID: NCT01302444 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Treprostinil Combined With Tadalafil for Pulmonary Hypertension

T2
Start date: March 2011
Phase: Phase 4
Study type: Interventional

Objectives: To test whether the combined administration of the medications treprostinil(a prostacycline therapy), and tadalafil(a PDE-5 [ phosphodiesterase type 5]Inhibitor therapy) is better than the administration of treprostinil alone. This treatment would be offered to newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for this disease and are deemed candidates for the medication treprostinil by their physician. The combination therapy will be compared to single therapy with only treprostinil in a double-blind manner. Current therapy is to begin one treatment, either a PDE5 inhibitor or a prostacycline, depending on the severity of the patient's PAH (pulmonary arterial hypertension) disease and add additional therapies as deterioration occurs. This treatment could add two agents initially. Secondary objectives are: To improve pulmonary arterial pressures as measured through a cardiac echocardiogram, improve the subject's 6minute walk distance, delaying the time to clinical worsening, and lowering plasma BNP levels. Research Procedures: To begin the administration of both treatments at the same time. Time period is 16 weeks with a one- year follow-up. Cardiac Echocardiograms, clinic physician exams, and lab work will be followed. Subjects will be between the ages of 18 - 75.

NCT ID: NCT01295216 Terminated - Hypertension Clinical Trials

Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings

Start date: September 2011
Phase: N/A
Study type: Interventional

Nearly half of the adult population in Latin American urban settings has abnormally high blood pressure. Although half of these subjects with high blood pressure are still in the pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range), the rate of progression to hypertension is high (10-20% per year), according to studies done in other settings. The main objective of this proposal is to evaluate the effectiveness of an affordable and sustainable primary health care intervention to reduce blood pressure and prevent progression from pre-hypertensive status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and Peru. Our primary hypotheses are that pre-hypertensive subjects who receive mHealth (mobile health) support for 12 months (intervention group) will have lower blood pressure compared to individuals who receive the usual primary health care (control group); and that pre-hypertensive subjects will maintain lower blood pressure six months after receiving mHealth support. The investigators will determine the effects of an intervention using mHealth technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants. The intervention also aims to help participants become better informed, motivated, and encouraged to practice self-management of their own health; to improve patient satisfaction levels; provide tailored targeted interventions; and to improve patient-provider relationships. The proposal is designed as a proof-of-concept intervention in three Latin American countries that encompass a wide range of environments and health care settings. A total of 212 subjects (30-60 years old) per country will be recruited in primary health clinics and randomized to study groups. Blood pressure, anthropometry, and behavioral risk factors (physical activity, diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12 during the intervention, and six months after the end of the intervention. The investigators will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation of the intervention.

NCT ID: NCT01292694 Terminated - Hypertension Clinical Trials

Contribution of Angiotensin II to Supine Hypertension in Autonomic Failure

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the hypothesis that angiotensin II plays a role in the supine hypertension of primary autonomic failure. To determine the contribution of angiotensin II to renin and blood pressure regulation in autonomic failure, patients with multiple system atrophy [MSA] or pure autonomic failure [PAF] and supine hypertension will undergo medication testing with the angiotensin II receptor blocker losartan. The investigators will compare the biochemical and hemodynamic effects between MSA and PAF patients. In a subset of patients, the investigators will also give the ACE inhibitor captopril. Our primary endpoint will be changes in plasma renin activity, and subsequent components of the circulating renin-angiotensin system, in response to angiotensin II blockade. Our secondary outcome will be changes in hemodynamic measures during administration of these drugs.

NCT ID: NCT01244620 Terminated - Clinical trials for Pulmonary Arterial Hypertension

A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

Start date: November 2010
Phase: Phase 1
Study type: Interventional

Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5 inhibitor). Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.