MANP in Hypertension and Metabolic Syndrome (MANP-HTN-MS)

This is an interventional treatment trial for Hypertension Read More

Inclusion Criteria:

• Hypertension defined as 140 mmHg ≤ systolic BP ≤ 180 mmHg or 90 mmHg ≤ diastolic BP ≤ 100 mmHg despite anti-hypertensive medical therapy
• Metabolic Syndrome defined as the presence of any two of the following traits:
• Abdominal obesity, defined as a waist circumference in men ≥102 cm (40 in) and in women ≥88 cm (35 in)
• Serum triglycerides ≥150 mg/dL (1.7 mmol/L)
• Serum HDL cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL cholesterol
• Fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose
• Between the ages of 18 and 75 years
• Use of antihypertensive medications at a stable dose for 30 days preceding screening visit.
• Use of statins or ezetimibe or combinations on stable dose for 60 days preceding screening visit.

Exclusion Criteria:

• Known hypersensitivity or allergy to MANP or its components, carperitide, other natriuretic peptides, or related compounds;
• Subjects with orthostatic hypotension at the screening visit, defined as a decrease in systolic BP of >20 mmHg or a decrease in diastolic BP of >10 mmHg within three minutes of standing when compared with blood pressure from the sitting position.
• Subjects with a systolic BP >180 mmHg or a diastolic BP >100 mmHg
• Women of child-bearing potential
• The presence of abnormal laboratory values at screening visit considered clinically significant by the Investigator. Specifically they will be excluded if a) Serum sodium of < 135 mEq/dL or > 145 mEq/dL; b) Serum potassium of < 3.5 mEq/dL or > 5.1 mEq/dL
• Subjects whose body weight has changed more than 3% in the last 3 months
• Having received any investigational drug or device within 30 days prior to entry into the study;
• A history (within the last 2 years) of alcohol risky use (defined as more than 14 standard drinks per week on average or more than 4 drinks on any day for men under age 65 - defined as more than 7 standard drinks per week on average or more than 3 drinks on any day for women and adults 65 years and older);
• A history of illicit drug use, psychiatric illness that might impair the participation to the study, physical dependence to any opioid, or any history of substance abuse or addiction;
• A history of difficulty with donating blood or donated blood or blood products within 45 days prior to enrollment;
• Clinically significant new illness in the 1 month before screening in the opinion of the Investigator;
• History of severe allergies;
• History of coronary artery disease or cerebrovascular disease or syncope;
• History of epilepsy or other seizure disorder;
• History of organ transplantation;
• Malignancy within 5 years of the screening visit (with the exception of basal cell and squamous cell skin carcinoma);
• Clinically significant intrinsic renal disease, renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries;
• Consumption of a phosphodiesterase-5 inhibitor (sildenafil, vardenafil, or tadalafil) within 72 hours of receiving MANP.
• Episodic or chronic use of nitrates (Isordil, nitroglycerine), MAO inhibitors, antipsychotics, antiarrhythmics, psychostimulants, systemic corticosteroids, cholestyramine and cholestipol reisins, fibrates, nicotinic acid, cyclosporin, rifampin or other highly potent PgP inhibitors.
• Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
• Subjects who smoke or have any history of tobacco product use more recently than 6 months prior to the enrollment into the study