Status:
TERMINATED
Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
Dialysis Clinic, Inc.
University of Pittsburgh
Conditions:
Proteinuria
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine with the administration of amiloride, observe an enhanced natriuresis, reduction in blood pressure and weight compared to the administration of hydrochlorothi...
Detailed Description
Renal sodium retention and extracellular fluid volume expansion are hallmarks of nephrotic syndrome. There is abundant evidence that this occurs even in the absence of activation of hormones that are ...
Eligibility Criteria
Inclusion
- Age 18 to 80 yrs at randomization
- History of Type 2 Diabetes
- Presence of systolic hypertension or pre-hypertension (average systolic blood pressure (SBP) ≥120 mmHg and \<180 mmHg.)
- Urinary protein/creatinine ratio \>300 mg/g creatinine at screening
- Hemoglobin A1C\<8%
- Willing and able to give informed consent
Exclusion
- Average SBP of ≥180 mmHg or diastolic blood pressure (DBP) of ≥110 mmHg
- Current symptomatic heart failure, history of New York Heart Association Class III or IV congestive heart failure, or left ventricular (LV) ejection fraction (by any method) \<25%; these patients may be harmed with withdrawal of diuretics
- Serum potassium level \<3.5 or \>5.0 at screening
- History of hyperkalemia in the last two years (serum K\>5.5)
- Contraindication to use of hydrochlorothiazide or amiloride
- Unstable angina pectoris or acute myocardial infarction (MI) in last 3 months
- Known secondary causes of hypertension (HTN) (screening for these conditions will not be required)
- Estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m², as determined by validated estimating equations
- On or expected to be on immunosuppressive therapy
- Any history of solid organ transplantation
- Significant dementia
- Other factors likely to limit adherence during trial (eg. alcohol or substance abuse, plan to move in next year, history of non-adherence to medications, appointments and medical care, reluctance of close family members to participate in trial, lack of support from primary healthcare provider)
- Participation in another investigational trial within 4 weeks of the screening visit
- Arm Circumference too large or too small to allow accurate blood pressure measurement
- Pregnancy or currently trying to become pregnant (although this is unlikely because of age limit
- Incarceration
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01804777
Start Date
March 1 2013
End Date
December 1 2014
Last Update
May 11 2018
Active Locations (1)
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1
University of New Mexico Hospital; Clinical & Translational Science Center
Albuquerque, New Mexico, United States, 87131