Clinical Trials Logo

Clinical Trial Summary

Evaluate the cardiovascular and metabolic properties of MANP in subjects with HTN and MS according to rs5068 genotypes


Clinical Trial Description

6 Study Procedures 6.1 Day 0 - Visit 1 (screening visit) 6.2 At visit 1 informed consent will be obtained (Table 1). Introduction and orientation to the study will take place. Medical history will be collected. Physical exam will be performed and laboratory exams history will be screened. Electrocardiogram will be recorded and screening laboratory tests will be performed. Blood pressure and heart rate will be recorded. Subjects will be instructed about the fluid intake allowed (2.5 liter/day) and the diet (moderate sodium intake: 3.0 gr/day) to follow for the duration of the study from day 1 to day 7. Subjects will be instructed on completing a 24-hour urine collection starting on day 4 at 4pm (see day 4 below). Antihypertensive medications are required to be at a stable dose for 30 days preceding visit 1 on day 1. Throughout the duration of the study subjects will be maintained on their chronic antihypertensive treatment except for day 6 in which MANP or placebo will be administered. Subjects will be instructed to avoid strenuous physical activities and to abstain from smoking and alcohol from day 1 until the completion of the study on day 7. Caffeine consumption will be prohibited from 7.00 pm on day 5 until the dismissal from the CRTU on day 7. Day 1 Start of diet and fluid restriction compliance. (Interval of time between day 0 and day 1 will depend upon the CRTU schedules 6.3 Day 4 On Day 4 at 4 pm the subjects will start 24-hour urine collection in order to establish adherence to the moderate sodium diet (Table 1). 6.4 Day 5 On day 5 at 4pm subjects will bring the 24-hour urine collection to the CRTU and 24-hour urine sodium will be measured. If the patient has been compliant with the sodium diet, she/he will be admitted to the CRTU to continue the study and a physical exam will be performed. At 7.00 pm subjects will start fasting and abstain from their usual hypoglycemic therapy in consideration of the blood draws for metabolic parameters that will be performed on day 6. Caffeine consumption is prohibited from 7:00 pm on day 5 until the dismissal from the CRTU on day 7. 6.5 Day 6 - Visit 2 On day 6 at 8:00 am enrolled patients will receive a single injection of MANP (2.5 μg/kg SQ) or placebo (0.9% saline solution) and will be under observation for the 24 hours following the MANP/placebo administration (Table 1). Blood pressure and heart rate will be monitored continually and recorded before MANP/placebo injection and at several intervals after MANP/placebo administration. Timed urine collection and blood samples to evaluate neurohumoral, renal function and metabolic plasma parameters will be collected prior to MANP /placebo injection and at different time points after MANP and placebo administration. Subjects will eat their meal and take their usual hypoglycemic medications after the last blood draw for metabolic parameters (4 hours after the MANP injection). Subjects will be maintained on their chronic antihypertensive treatment except for day 6 in which MANP will be administered. They will take their usual antihypertensive therapy 24 hours after MANP injection. 6.6 Day 7 Once completed the 24 hour observation following MANP administration a physical exam will be performed and the subjects will be dismissed from the CRTU 6.7 Day 14 (± 2 days) Laboratory tests will be performed and assessed. Subjects will be contacted by phone to review laboratory tests results and assess the onset of any potential side effect following the MANP/placebo administration. 6.8 Day 30 (-2 days, + 5 days) Blood collection for anti-MANP antibody testing will be performed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03781739
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 1
Start date August 18, 2017
Completion date December 10, 2019

See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A