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Hypertension clinical trials

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NCT ID: NCT03284099 Terminated - Hypertension Clinical Trials

Bedtime ACEIs/ARBs Versus Morning ACEIs/ARBs for Reverting Non-dipping Hypertension

Start date: December 1, 2017
Phase: Phase 4
Study type: Interventional

Background: Non-dipping (ND), defined as a <10% decrease in blood pressure (BP) during sleep, is an independent significant predictor of cardiovascular outcome in hypertensive patients. A few anti-hypertensive medications, including angiotensin receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEIs), may normalize dipping if administered at night. Chinese data are scarce and there are no prospective studies on cardiovascular outcomes in Chinese patients. Aim: To determine if the bedtime administration of ACEIs and ARBs is more effective at normalizing ND than morning administration. As a pilot project, the feasibility of recruiting hypertension patients in primary care for ambulatory blood pressure monitoring (ABPM) and conducting a clinical trial will be evaluated such that future larger randomized trials can be planned to determine treatments for ND. Method: Fifty patients diagnosed with essential hypertension who are receiving either ACEIs or ARBs and diagnosed with ND will be randomized to take ACEIs or ARBs either early morning or before bedtime. A follow-up 48-hour ABPM will be performed after 4-6 weeks to examine post-treatment changes in BP and ND status. Outcome: The primary outcome of this proposed study is the proportion of ND at 6 weeks; secondary outcomes will include (i) mean awake and asleep SBP/DBP of 48-hour duration (ii) feasibility of this pilot study will be assessed by recruitment and dropout rates during the study period. Potential: This pilot study will provide the basis for a future larger randomized controlled study to further examine the treatment for ND in primary care.

NCT ID: NCT03267108 Terminated - Clinical trials for Pulmonary Hypertension

A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension

REBUILD
Start date: December 14, 2020
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD

NCT ID: NCT03251872 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Olaparib for PAH: a Pilot Study

OPTION-p
Start date: October 25, 2018
Phase: Early Phase 1
Study type: Interventional

The main OBJECTIVE of this proposal is to extend our preclinical findings on the role of DNA damage and poly(ADP-ribose) polymerases (PARP) inhibition as a therapy for a devastating disease, pulmonary arterial hypertension (PAH), to early-phase clinical trials. We, and others, have published strong evidence that DNA damage accounts for disease progression in PAH and showed that PARP1 inhibition can reverse PAH in several animal models1. Interestingly, PARP1 inhibition is also cardioprotective. Olaparib, an orally available PARP1 inhibitor, can reverse cancer growth in animals and humans with a good safety profile, and is now approved for the treatment of ovarian cancer in Canada, Europe and the USA. The time is thus right to translate our findings in human PAH. The industry-sponsored clinical research on PARP1 inhibitor is currently entirely cancer-oriented. Nonetheless, AstraZeneca Canada accepted to support an early phase clinical trial through in-kind contribution, but the support from foundations and federal agencies is critical to catalyze early-stage development of PARP1 inhibitors for other indications, especially for orphan diseases. A CIHR Project Scheme grant will thus be submitted on September 15 2017, proposing a Phase 1, followed by a Phase 2 trial that will be conducted in recognized PAH programs throughout Canada. At this stage, however, we propose a pilot study to assess the feasibility of the proposed trials in the PAH population. The overall HYPOTHESIS is that PARP1 inhibition with olaparib is a safe and effective therapy for PAH. The primary objective of the study is to confirm feasibility, to support the safety of using olaparib in PAH patients, and precise the sample size of the coming Phase 1B trial. The feasibility of the comprehensive patient phenotyping that will be proposed within the phase 1B trial will thus be assessed, in addition to adverse events and efficacy signals. ***OPTION pilot trial was merged with the new OPTION multicenter trial (NCT03782818)***

NCT ID: NCT03179163 Terminated - Clinical trials for Hypertension,Essential

Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans

H2SPharm
Start date: July 20, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

High blood pressure can cause physical changes to the blood vessels of the body (remodeling). If a person who has high blood pressure also has a lot of blood vessel remodeling with their condition, they are more likely to have poor results with medical treatment for hypertension. The researchers examine the impact of different classes of drugs that doctors use to treat high blood pressure (hypertension) on blood vessel remodeling. Some drugs that doctors prescribe for their patients contain a "sulfhydryl group" (a sulfur atom bonded to a hydrogen atom). Drugs that have the sulfhydryl group may reduce blood vessel remodeling more that drugs that do not. For this study, participants who have high blood pressure perform the experiments, take a drug for 16-weeks to lower blood pressure, and repeat the experiments. The researchers randomly assign one of three drugs to participants who have high blood pressure: a diuretic ("water pill"), a drug containing a sulfhydryl (SH) group, or a drug that does not contain a sulfhydryl group. Participants who do not have high blood pressure perform the experiments, but do not take any of the drugs. In some of our experiments, the researchers use a technique called "microdialysis" (MD). With MD, the researchers perfuse some research drugs into the skin on the forearm through tiny tubing that mimics capillaries. These MD drugs mimic or block substances the body naturally makes to control the small blood vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go into the rest of the body. The researchers also analyze very small skin samples (skin biopsy) obtained from the forearm. Lastly, the researchers use a standard technique called "flow mediated dilation" (FMD) that uses blood pressure cuffs and ultrasound to look at the health of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin under the tongue during part of the test.

NCT ID: NCT03151096 Terminated - High Blood Pressure Clinical Trials

Pilot Evaluation of the Effect of Riboflavin Supplementation on Blood Pressure and Possible Effect Modification by the MTHFR C677T Genotype

RiboBP
Start date: May 2, 2018
Phase: N/A
Study type: Interventional

Hypertension, which results from a combination of multiple lifestyle and genetic factors, is a global public health problem affecting 1 billion people worldwide. The identification of cheap treatment interventions without adverse side effects would be hugely advantageous particularly in low-income settings with high prevalence of hypertension such as sub-Saharan Africa where up to 46% of adults are affected. Emerging evidence links a functional polymorphism in the MTHFR gene (rs1801133 C677T), encoding the folate-metabolising enzyme methylenetetrahydrofolate reductase to high blood pressure in adults. Variation at rs1801133 is relatively common and has 3 genotypes; homozygous "normal" CC, heterozygous CT and homozygous "variant" TT genotypes. Of these genotypes, the homozygous "variant" TT is more strongly associated with a higher BP. The precise mechanism by which MTHFR is associated with BP remains unclear. It has been recently shown in 3 separate randomized controlled trials that BP is highly responsive to riboflavin and that this response is differential by MTHFR rs1801133 genotype. In all these clinical trials, significant reduction in both systolic and diastolic blood pressure was observed in the homozygous variant TT genotype and an intermediate effect seen in those with the heterozygous CT genotype. The aim of this study is to evaluate the effect of riboflavin supplementation on blood pressure in a riboflavin-deplete population as well as comparing plasma riboflavin status before and after supplementation. This will be achieved by conducting a randomized single-blind placebo controlled trial over a period of 16 weeks. The Investigators will use the Keneba biobank to invite about 100 adults with the CT genotype and a similar number of age-, sex and village-matched CC homozygotes. Participants within each of the groups will be randomized to receive either riboflavin (5mg/d) or a matching placebo which would be supplied on a weekly basis. Blood sample, blood pressure measurement, socio-demographic data and their anthropometric measurements (height, weight, waist and hip circumference and body composition by BIA) will be taken during the initial visit. An additional blood sample will be taken at the end of the study whilst additional BP measurements will be taken respectively at 8 weeks and at the end of the intervention. The possibility that riboflavin deficiency represents a new, easily-correctible causal factor in hypertension in sub-Saharan Africa would require further large-scale interventions if this pilot study yields encouraging results.

NCT ID: NCT03135860 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect iNO on Functional Respiratory Imaging in Subjects With WHO Group 3 Pulmonary Hypertension With COPD on Oxygen

Start date: October 2016
Phase: Early Phase 1
Study type: Interventional

The objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of long term iNO administrationusing the device INOpulse for 4 weeks in relation to Patient Reported Outcome (PRO) and exercise tolerance in subjects with WHO Group 3 PH associated with COPD on LTOT. Changes from baseline to 4 weeks of pulsed iNO and after 2 weeks of withdrawal from pulsed iNO will be evaluated.

NCT ID: NCT03132428 Terminated - Clinical trials for Pulmonary Hypertension of Newborn

Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

PaTTerN
Start date: July 27, 2017
Phase:
Study type: Observational

Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through. Some babies are born with pulmonary hypertension (PH). Doctors might use INOmax (a gas the baby breathes) to help newborn babies (neonates) with PH. This study will use information from the records of registered babies to see how effective and safe INOmax is for treating premature and other newborn babies for up to 11 days after they are born.

NCT ID: NCT03121092 Terminated - Hypertension Clinical Trials

ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients

ACE/ARB
Start date: May 16, 2012
Phase: N/A
Study type: Interventional

Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) are commonly used anti-hypertensive medications that may have implications on the management of a patient undergoing surgery. Limited research has looked at the effects of these medications on perioperative complications and mortality. Some studies conducted on small groups of inpatients with advanced vascular disease undergoing vascular surgery or coronary artery bypass grafting (CABG), suggest exacerbation of hypotension (low blood pressure) in patients who continued taking ACEI's or ARB's on the morning of their procedure. In addition, cases of low blood pressure (BP) that were refractory to standard treatment were reported. One recent retrospective study reported no difference in severe hypotension and only a modest difference in moderate hypotension managed by conventional treatment, but did not adequately address the risk of preoperative hypertension. A study recently published by the investigators (Twersky et al., 2014) in over 600 patients demonstrated no difference in preoperative hypertension in ambulatory surgery and same day admission patients. There has been limited data stratifying the degree of low BP based on severity but these were not done in ambulatory patients, and neither was the degree of high BP from discontinuing these medications addressed. As such, no uniform consensus has been reached and clinicians are unclear as to whether the reported inpatient findings are applicable to the outpatients, since they differ in many respects. The investigators propose to evaluate whether ACEI's and ARB's discontinued preoperatively have a negative impact on perioperative hemodynamics and patient outcome in a group of ambulatory and same day surgical patients. Similar to studies done on inpatients, the investigators will also evaluate patients receiving a standardized general anesthetic for hemodynamics following induction of anesthesia until surgical incision. The investigators hypothesize that continuing ACEI's and ARB's in the preoperative period does not result in an increased risk of severe hypotension (low blood pressure) following induction of general anesthesia.

NCT ID: NCT03109795 Terminated - Hypertension Clinical Trials

Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System

ATLAS
Start date: April 10, 2017
Phase: Phase 4
Study type: Interventional

The goal of this study is to evaluate the effectiveness of a short-term (4 weeks) pharmacological blockade of sympathetic nerve activity (clonidine) on anxiety symptoms, vascular function, inflammation, muscle sympathetic nerve activity, and oxidant stress in individuals with moderate-to-high anxiety. Individuals who are interested in the study will be identified by an online screening survey and will be contacted by the research team; advertisements, flyers and mass emails will direct individuals to the online screening survey. Those deemed eligible to participate will be randomized to either the clonidine intervention or hydrochlorothiazide as a blood-pressure lowering control condition. If eligible participants are currently being treated with blood pressure-lowering medications, they will be asked to go off these medications for 2 weeks prior to and during the course of the study. During the 2 week washout of blood pressure-lowering medications, participants will have safety visits (2 additional visits) that include measurements of blood pressure at 4 days and 7 days after the beginning of the washout period before the intervention. Assessments of anxiety symptoms via various surveys, vascular function (via non-invasive, well-established techniques), inflammation, muscle sympathetic nerve activity, and oxidant stress will be performed at baseline and at the post intervention session. Similar baseline measurements will be performed in control subjects with low or no anxiety for comparison, but these individuals will not undergo the intervention. Participants with moderate-to-high anxiety will have a total of 6 visits to the laboratory, which includes the screening and consent (visit 1). Visit 2 (baseline measurements) and visit 6 (post-intervention measurements) will be more extensive (~4.5 hours) compared to the other visits (~30 min). Participants completing the washout will have an additional 2 visits (~30 min each) before "visit 2." Control subjects with low or no anxiety will only participate in visit 1 (screening and consent ) and visit 2 (baseline measurements).

NCT ID: NCT03106597 Terminated - Hypertension Clinical Trials

Manidipine Versus Amlodipine in Patients With Hypertension

Start date: August 20, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of a third-generation Calcium Channel Blocker (CCB), manidipine, compared with second-generation Calcium Channel Blocker (CCB), amlodipine, on the development of peripheral edema using Direct Segmental Multi-Frequency Bioelectrical Impedance Analysis (DSM-BIA) method in patients with mild to moderate essential hypertension. Investigator expects this study could show more objective evidence of better safety of manidipine compared with amlodipine for peripheral edema.