Status:
COMPLETED
MANP in Hypertension and Metabolic Syndrome
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
American Heart Association
Conditions:
Hypertension
Metabolic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Evaluate the cardiovascular and metabolic properties of MANP in subjects with HTN and MS according to rs5068 genotypes
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03781739
Start Date
August 18 2017
End Date
December 10 2019
Last Update
November 13 2020
Active Locations (1)
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1
Mayo Foundation
Rochester, Minnesota, United States, 55905