MANP in Hypertension and Metabolic Syndrome — MANP-HTN-MS  

Hypertension Clinical Trial

Official title: A PHASE I, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE CARDIOVASCULAR AND METABOLIC PROPERTIES OF MANP IN SUBJECTS WITH HYPERTENSION AND METABOLIC SYNDROME ACCORDING TO RS5068 GENOTYPES

Status Completed

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. ;

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Syndrome

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