Nitrite + NAC Mix for High Blood Pressure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Organic nitrates, Sildenafil
Disqualifiers: Under 21, Pregnant, Cardiovascular, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The purpose of the study is to increase the in vivo levels of nitric oxide by generating nitric oxide donor compound S-nitrosoacetylcysteine (SNOAC) using the mixture of sodium nitrite and N-acetylcysteine crystals in the sublingual space. The generated SNOAC rapidly diffuses into blood circulation thereby decrease the systemic blood pressure. This compound can be an alternative to organic nitrate NO donor drugs without developing tolerance in patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking organic nitrates or sildenafil-based drugs, you will not be eligible to participate.
What data supports the effectiveness of the drug for high blood pressure?
Research shows that N-acetylcysteine (NAC) can enhance the blood pressure-lowering effects of certain medications and has been found to reduce blood pressure in some studies, particularly in younger individuals. Additionally, NAC has antioxidant properties that may help improve blood vessel function, which can contribute to lowering blood pressure.12345
Is the combination of Nitrite and NAC safe for humans?
Research on N-acetylcysteine (NAC) shows it is generally safe and can enhance the effects of other treatments, like nitroglycerin, in heart conditions. It also has protective effects against high blood pressure in animal studies, suggesting it may be safe for human use, but specific safety data for the combination with nitrite is not available.12346
What makes the Nitrite + NAC Mix drug unique for high blood pressure?
The Nitrite + NAC Mix is unique because it combines sodium nitrite and N-acetylcysteine (NAC) to potentially offer a novel mechanism for managing high blood pressure, unlike traditional treatments that often focus on different pathways. This combination may provide a new approach by leveraging the individual properties of nitrite and NAC, which have been studied for other uses but not commonly combined for this condition.7891011
Eligibility Criteria
This trial is for healthy men and women over 21 who agree to blood draws and blood pressure checks. It's not for those under 21, pregnant, with major heart issues or sickle cell disease, in jail, unable to consent, have low blood pressure or take certain heart medications.Inclusion Criteria
I am at least 21 years old and agree to participate in the study.
I am willing to have my blood drawn and my blood pressure checked.
Exclusion Criteria
My blood pressure is normal or high, and I'm not on nitrates or sildenafil.
I am over 21, not pregnant, don't have major heart problems or sickle cell disease, not incarcerated, and can consent.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive sublingual administration of sodium nitrite and N-acetylcysteine to generate S-nitrosoacetylcysteine and measure its effects on systemic blood pressure
11 months
Regular monitoring visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Mixture of Sodium Nitrite and N-acetylcysteine (NAC) crystals (Nitric Oxide Donor)
Trial OverviewThe study tests a mix of Sodium Nitrite and N-acetylcysteine crystals placed under the tongue to create SNOAC. This may lower high blood pressure without the tolerance seen with some other nitrate drugs.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: sodium nitrite and N-acetycysteine mixtureExperimental Treatment1 Intervention
sodium nitrite 2.5mg + N-acetylcysteine 50mg
Sodium nitrite 5 mg + N-acetylcysteine 50mg
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Anesthesiology and Perioperative MedicineBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
N-acetylcysteine potentiates the antihypertensive effect of ACE inhibitors in hypertensive patients. [2019]Sulfhydryl group donors, such as N-acetylcysteine (NAC), may enhance the antihypertensive effect of some drugs through a nitric oxide (NO) mechanism. It has been observed that the hypotensive effect of angiotensin-converting enzyme inhibitors (ACEIs) is, at least partially, mediated by NO. We performed a within patient crossover study with the aim to investigate the potential effect of NAC on the ACEI antihypertensive action, via an NO-dependent mechanism. We studied 18 smoker (> 10 years of habit and > 10 cigarettes daily) hypertensive patients (15 males and three females, aged 69 +/- 5 years) on ACEI therapy (11 captopril and seven enalapril). Patients were randomly allocated to two treatment arms. In one arm, the patients (n = 10) initially received the addition of NAC (600 mg t.i.d.) to the ACEI regimen. In the other group (n = 8), the patients remained only on ACEI. After 21 days, the therapeutic patterns were crossed. The first group received only ACEI, and the second group received ACEI and NAC and completed other 21-day treatment period. We evaluate the effect of NAC on each patient by ambulatory blood pressure monitoring (ABPM), performed at the end of each therapeutic regimen. A significant decrease in systolic and diastolic 24-h blood pressure (24 hBP) and daytime BP (dtBP) was achieved with the combination of ACEI and NAC (ACEI + NAC) when compared to the period with only ACEI: 24 hBP = 146.1 +/- 4.2 vs 137 +/- 3.1 (p
N-acetylcysteine in combination with nitroglycerin and streptokinase for the treatment of evolving acute myocardial infarction. Safety and biochemical effects. [2019]N-acetylcysteine (NAC) has been shown to potentiate the effects of nitroglycerin (NTG) and to have antioxidant activity. This is the first study to assess the safety and effect of NAC in the treatment of evolving acute myocardial infarction (AMI).
Effect of chronic N-acetylcysteine treatment on the development of spontaneous hypertension. [2013]The imbalance between NO (nitric oxide) and ROS (reactive oxygen species) is an important factor in the development of hypertension. The aim of the present study was to determine the preventive and therapeutic effects of NAC (N-acetylcysteine) in SHRs (spontaneously hypertensive rats). Young and adult SHRs and WKY (Wistar-Kyoto) rats were treated with NAC (20 g/l in the drinking water). After 8 weeks of treatment, BP (blood pressure) and NOS (NO synthase) activity, conjugated dienes and GSH (reduced glutathione) in the kidney and left ventricle were determined. Protein expression of eNOS (endothelial NOS), inducible NOS and NF-kappaB (nuclear factor kappaB) were also determined in the left ventricle and kidney. Chronic NAC treatment partially attenuated the rise in BP in young SHRs (179+/-6 compared with 210+/-8 mmHg in untreated animals), but it had no significant effect on BP in adult SHRs. The antioxidant action of NAC, measured as a decrease of the concentration of conjugated dienes or inhibition of NF-kappaB expression, was greater in young than in adult SHRs. Similarly, eNOS protein expression was attenuated more in young than in adult SHRs, although NAC treatment increased NOS activity to a similar extent in both young and adult rats. In conclusion, both decreased ROS production and increased NOS activity appear to participate in the BP changes after NAC treatment in young SHRs. In adult SHRs with established hypertension, however, the secondary alterations (such as pronounced structural remodelling of resistance vessels) might attenuate the therapeutic effect of NAC.
N-acetylcysteine-induced vasodilation involves voltage-gated potassium channels in rat aorta. [2013]N-acetylcysteine (NAC) has a protective effect against vascular dysfunction by decreasing the level of reactive oxygen species (ROS) in experimental and human hypertension. This study was designed to examine whether NAC would relax vascular rings in vitro via nitric oxide-cyclic guanosine monophosphate (NO-cGMP) pathway, extracellular Ca2+ and/or K+ channels.
Effect of N-Acetylcysteine on Metabolic Profile in Metabolic Syndrome Patients. [2021]Background: N-acetylcysteine (NAC), the acetylated variant of amino acid l-cysteine, acts as a free radical scavenger and plays multifunctional roles by suppressing endogenous level of oxidative stress and inflammation and by enhancing nitric oxide bioavailability. Thus, present study aimed to evaluate the efficacy of NAC on various inherent components of metabolic syndrome (MetS). Methods: An open-label pilot study was conducted at diabetes outpatient clinic. Thirty-five patients (aged ≥18 years) fulfilling the NCEP-ATP III diagnostic criteria for MetS were recruited and allocated to NAC tablets as 600 mg (twice a day) along with their ongoing therapeutic regimen. Blood pressure (BP), body mass index, lipid profile, fasting plasma glucose and insulin, insulin resistance estimated by homeostatic model assessment (HOMA-IR), high-sensitivity C-reactive proteins (hsCRP), nitrite, and thiobarbituric acid reactive substances (TBARS) were measured after 6 weeks treatment. Results: HOMA-IR, hsCRP and systolic BP were decreased significantly from 4.74 ± 0.30% to 3.86 ± 0.21%; 5.66 ± 0.27 to 4.92 ± 0.18 mg/L; and 133.2 ± 1.84 to 128.3 ± 1.52 mmHg, respectively. Among dyslipidemic variables, there was decrease in triglycerides from 194.20 ± 5.03 to 188.04 ± 4.93 mg/dL, but increase in HDL from 33.32 ± 0.19 to 36.29 ± 1.16 mg/dL. Nitrite levels were significantly increased from 6.25 ± 0.20 to 7.92 ± 0.18 μmol/L (P = 0.04), while TBARS levels were decreased from 14.65 ± 0.32 to 13.68 ± 0.33 nmol/L (P = 0.05). It was found from correlation analysis that hsCRP was the main culprit, that is, inflammation was perpetuator of endothelial dysfunction, IR, oxidative stress, hypertension, and vice-versa. Conclusion: This study has provided a new approach of management of MetS with NAC beyond controlling the disease with various drug therapies. NAC may reduce the risk burden via multiple antioxidant, anti-inflammatory, and vasodilatory effect.
Chronic N-acetylcysteine administration prevents development of hypertension in N(omega)-nitro-L-arginine methyl ester-treated rats: the role of reactive oxygen species. [2015]The aim of this study was to evaluate the production of superoxide anions as well as their role in the induction and/or maintenance of high blood pressure in rats with N(omega)-nitro-L-arginine methyl ester (L-NAME)-induced hypertension. In the preventive study, we compared adult Wistar rats treated with L-NAME for 4 weeks with L-NAME-treated rats that were simultaneously given N-acetylcysteine (NAC) in their drinking water. Basal blood pressure, superoxide production, conjugated dienes concentration and NO synthase (NOS) activity were measured at the end of the experiment. Chronic NOS inhibition by L-NAME treatment increased blood pressure, enhanced superoxide production in the aorta and elevated the concentration of conjugated dienes in the heart and kidney. All these changes were prevented by simultaneous NAC administration, which augmented NOS activity in L-NAME-treated rats. In the therapeutic study, the effects of chronic NAC treatment were studied in rats with established hypertension which developed during 4 weeks of L-NAME administration. The blood pressure effects of chronic NAC treatment in established L-NAME hypertension were only moderate, although this treatment also restored NOS activity and lowered conjugated dienes in the heart and kidney. Since chronic NAC treatment had better preventive than therapeutic effects, it seems that reactive oxygen species play a more important role in the induction than in the maintenance of L-NAME hypertension.
Evaluation of Mechanical and Shrinkage Behavior of Lowered Temperatures Cementitious Mortars Mixed with Nitrite-Nitrate Based Accelerator. [2020]Recently, calcium nitrite (Ca(NO2)2) and calcium nitrate (Ca(NO3)2) have been increasingly used as the main components of salt- and alkali-free anti-freezing agents, for promoting concrete hydration in cold-weather concreting. With an increase in the amount of nitrite-based accelerator, the hydration of C3A, C3S, and βC2S in the cement is accelerated, thereby improving its early strength and effectively preventing the initial frost damage. Meanwhile, with an increase in the amount of nitrite-based accelerator, the expansion and shrinkage of the concrete-and, therefore, the crack occurrence-are expected to increase. In this study, various experiments were conducted on shrinkage, crack initiation, and the development of mortar containing a considerable amount of a nitrite-based accelerator. The result confirmed that, as the amount of nitrite-based accelerator was increased, the shrinkage was increased, and cracking in early age was more likely to occur, compared to the cases without the addition of this accelerator.
Study on Physical Properties of Mortar for Section Restoration Using Calcium Nitrite and CO2 Nano-Bubble Water. [2020]This study investigated the physical properties of section-restoration mortar with calcium nitrite (Ca(NO2)2) and carbon dioxide (CO2) nanobubble mixing water to develop materials and methods for the repair and reinforcement of cracks in reinforced concrete (RC) structures. As the calcium nitrite content increased, the generation rate and generated amount of nitrite-based hydration products also increased, owing to the rapid reaction between NO2- ions in calcium nitrite and C3A(Al2O3). Further, the reaction with C3S and C2S was accelerated, thereby increasing the generation rates of Ca(OH)2 and C-S-H. The large amount of Ca2+ ions in these hydration products reacted with CO32- ions in CO2 nanobubble water, thereby increasing the generation of calcite-based CaCO3 in the cement matrix. This appears to have affected strength development and durability improvement via the densification of the structure. These results suggest that the performance of polymer cement mortar for repairing concrete structures can be improved if calcium nitrite and CO2 nanobubble water are properly combined and applied.
In Vitro Evaluation of Different Solvents for Retrieval of Mineral Trioxide Aggregate and Calcium-Enriched Mixture. [2022]The purpose of this study was to evaluate the effect of different solvents; carbonic acid (H2CO3), hydrochloric acid (HCl), chlorhexidine (CHX) and sodium hypochlorite (NaOCl) on the surface hardness of mineral trioxide aggregate (MTA) and calcium-enriched mixture (CEM) cement.
Effect of decontamination procedures on recovery of Nocardia spp. [2021]Exposure to 0.5% N-acetyl-L-cysteine (NAC), 2% NaOH-NAC, or benzalkonium chloride in trisodium phosphate (Zephiran-TSP) was toxic for Nocardia isolates. The number of viable Nocardia cells in a standardized suspension was reduced by 10(2) to 10(6) after a 30-min exposure to 2% NaOH-NAC and by 10(4) or more after a 30-min treatment with Zephiran-TSP.
Physicochemical Study on the Strength Development Characteristics of Cold Weather Concrete Using a Nitrite-Nitrate Based Accelerator. [2020]There has recently been an increased use of anti-freezing agents that are primarily composed of salt- and alkali-free calcium nitrite (Ca(NO2)2) and calcium nitrate (Ca(NO3)2) to promote the hydration reaction of concrete in cold weather concreting. Nitrite-nitrate based accelerators accelerate the hydration of C3A and C3S in cement more quickly when their quantities are increased, thereby boosting the concrete's early strength and effectively preventing early frost damage. However, the connection between the hydrate formation behavior and the strength development characteristic over time has yet to be clearly identified. Therefore, in this study, a wide range of physicochemical reviews were carried out to clarify the relationship between the hydrate formation behavior and the strength development characteristics, both at an early age and at later ages, which results from the addition of nitrite-nitrate based accelerators to concrete in varying amounts. These accelerators also act as anti-freezing agents. The results show that an increased quantity of nitrite-nitrate based accelerators caused an increase in the early strength of the concrete. This was due to the formation of nitrite and nitrate hydrates in large amounts, in addition to ettringite containing SO42, which is generated during the hydration reaction of normal Portland cement at an early age. On the other hand, at later ages, there was a rise in nitrite and nitrate hydrates with needle crystal structures exhibiting brittle fracture behavior. A decrease in C-S-H gel and Ca(OH)2 hydrates, deemed to have caused a decline in strength on Day 3 and thereafter, was also observed.