Hypertension Clinical Trial
Official title:
ENaC as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes
Verified date | May 2018 |
Source | University of New Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Hospital; Clinical & Translational Science Center | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico | Dialysis Clinic, Inc., University of Pittsburgh |
United States,
Passero CJ, Hughey RP, Kleyman TR. New role for plasmin in sodium homeostasis. Curr Opin Nephrol Hypertens. 2010 Jan;19(1):13-9. doi: 10.1097/MNH.0b013e3283330fb2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Pressure | Change in clinic systolic BP. This BP measure will be the average of three serial BP measurements taken one minute apart after 5 minutes of sitting quietly. | one month | |
Secondary | Hypertension | To demonstrate effect size on relevant hypertension outcomes such as volume status and urinary sodium excretion. Also assess the fractional excretion of sodium (FENa) and chloride (FECI). Endpoint will be the 24 hour urine excretion. | one month |
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