MANP in Hypertension and Metabolic Syndrome

Completed · Phase 1 · Has a placebo group

Conditions studied: Hypertension, Metabolic Syndrome

In brief

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

Key facts

Study ID

NCT03781739

Run by

Mayo Clinic

People needed

22

Starts

2017-08-18

Expected to finish

2019-12-10

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Foundation — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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