Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01275352
Status:
WITHDRAWN
Last Update Posted:
2015-06-03
First Post:
2011-01-10
Brief Title:
CLCNKA Ka Renal Chloride ChannelClC-Ka Polymorphism Effects on Hypertrophy Regression
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Randomized Double Blind Pilot Study Evaluating CLCNKA Ka Renal Chloride ChannelClC-Ka Polymorphism Effects on Hypertrophy Regression in Caucasian Hypertensive Patients Treated With Eplerenone
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will consist of middle-aged Caucasian non-failing subjects with high blood pressure who are homozygous for a gene that confers increased risk of developing heart failure the Glycine 83 variant of the Ka renal chloride channel ClC-Ka GlyGly 83 or middle-aged Caucasian non-failing hypertensive subjects who lack the heart failure risk gene the wild-type Arginine 83 Ka renal chloride channel ClC-Ka ArgArg 83 Subjects on standard therapy for high blood pressure with an angiotensin converting inhibitor ACEI or angiotensin receptor blocker ARB will be randomized to additional treatment with eplerenone an aldosterone antagonist or placebo and assessed for changes in echocardiographic left ventricular hypertrophy LVMI Secondary endpoints will assess left ventricular remodeling and other echocardiographic variables The investigators hypothesize that subjects homozygous for the CLCNKA risk allele will have a greater response to eplerenone in terms of reductions in LVMI than those lacking the risk allele
Detailed Description:
The screening phase will involve identifying Caucasian hypertensive patients who are homozygous for the ClC-Ka GlyGly83 and the ClC-Ka ArgArg 83 allele All patients will be on background therapy with an angiotensin converting enzyme inhibitor ACEI or angiotensin receptor blocker ARB at least mid range dosing If patient is not at recommended dose of ACE or ARB they must be titrated up and be stable on a midrange dose of ACEI or ARB for at least 4 weeks before they can be entered into the study There will be 2 treatment phases Phase 1 will be up to 4 weeks in duration and will consist of randomization to one table of eplerenone 25 mg or matching placebo On week 2 the patient will be up titrated to two tablets of eplerenone 50 mg or matching placebo to achieve a target dose of 50 mg of eplerenone If the patient cannot tolerate two tablets of eplerenone or matching placebo they can be down titrated to one tablet of eplerenone or matching placebo The target BP on study medication is 13080 mmHg After the patients have been up titrated to the maximally tolerated dose of study medication the background hypertension therapy can be adjusted to reach the target BP of 13080 mmHg by the end of week 4 Phase 2 will be 52 weeks in duration to assess the effects of placebo or eplerenone on LV hypertrophy Serum potassium will be monitored throughout the study and if necessary doses of eplerenone will be titrated down as necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None