Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 hydrochlorothiazide in Type 2 Diabetics.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Collaborators: Dialysis Clinic, Inc.; University of Pittsburgh
• Treatments: Amiloride; Hydrochlorothiazide

Criteria

• Inclusion Criteria:

1. Age 18 to 80 yrs at randomization

2. History of Type 2 Diabetes

3. Presence of systolic hypertension or pre-hypertension (average systolic blood pressure (SBP) ≥120 mmHg and <180 mmHg.)

4. Urinary protein/creatinine ratio >300 mg/g creatinine at screening

5. Hemoglobin A1C<8%

6. Willing and able to give informed consent

• Exclusion Criteria:

1. Average SBP of ≥180 mmHg or diastolic blood pressure (DBP) of ≥110 mmHg

2. 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

3. Serum potassium level <3.5 or >5.0 at screening

4. History of hyperkalemia in the last two years (serum K>5.5)

5. Contraindication to use of hydrochlorothiazide or amiloride

6. Unstable angina pectoris or acute myocardial infarction (MI) in last 3 months

7. Known secondary causes of hypertension (HTN) (screening for these conditions will not be required)

8. Estimated glomerular filtration rate (GFR) <60 mL/min/1.73m², as determined by validated estimating equations

9. On or expected to be on immunosuppressive therapy

10. Any history of solid organ transplantation

11. Significant dementia

12. 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)

13. Participation in another investigational trial within 4 weeks of the screening visit

14. Arm Circumference too large or too small to allow accurate blood pressure measurement

15. Pregnancy or currently trying to become pregnant (although this is unlikely because of age limit

16. Incarceration