A Study to Evaluate the Use of MANP in Patients with Hypertension and Metabolic Syndrome

Overview

About this study

This study is being done to see how a subcutaneous (SQ or subcu) injection of a new natriuretic peptide, or hormone, called MANP affects your blood pressure, the glucose and lipids levels and other peptide (hormone) levels in your blood.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  •  Fish oil, omega 3 or other medications prescribed for lipid levels which are not mentioned in these instructions:
    • They can be taken according to the usual regimen

Exclusion Criteria

Subjects who met any of the following criteria will be excluded from the study:

  • 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  
  • 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.
  • 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.
  • Nonsteroidal anti-inflammatory drugs including Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) are NOT allowed within 48 hours before the screening visit
  • Aspirin:
    • Chronic/Daily use for cardiac prophylaxis only. Not to exceed 325mg daily
  • Herbal remedies:
    • Chronic/daily and episodic use is NOT allowed throughout the study
  • Vitamin and mineral replacements:
    • Stable dose for 60 days preceding screening visit
  • Thyroid medication may be used if stable regimen is established and subject has history of controlled thyroid disease. Dose expected to remain constant throughout the study.
  • Inhaled, topical and nasal corticosteroid preparations are NOT allowed within 48 hours before the screening visit
  • Oral or inhaled sympathomimetics (β-agonists) bronchodilators and over the counter cold/decongestant products that contain a β-agonist are NOT allowed within 48 hours before the screening visit
  • Potassium supplements:
    • Chronic/daily use is allowed if at a stable dose for at least 14 days before the screening visit
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul McKie, M.D.

Closed for enrollment

Contact information:

Lynn Harstad

(507) 284-4838

lharstad@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20305077

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