CLCNKA (Ka Renal Chloride Channel[ClC-Ka]) Polymorphism Effects on Hypertrophy Regression
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ClinicalTrials.gov Identifier: NCT01275352 |
Recruitment Status
:
Withdrawn
(Lack of funding)
First Posted
: January 12, 2011
Last Update Posted
: June 3, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Eplerenone Drug: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double Blind Pilot Study Evaluating CLCNKA (Ka Renal Chloride Channel[ClC-Ka]) Polymorphism Effects on Hypertrophy Regression in Caucasian Hypertensive Patients Treated With Eplerenone |
Study Start Date : | December 2011 |
Estimated Primary Completion Date : | December 2014 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1
Caucasian hypertensive patients who are homozygous for the ClC-Ka Gly/Gly83 allele
|
Drug: Eplerenone
Eplerenone 50 mg/day
Other Names:
|
Active Comparator: Arm 2
Caucasian hypertensive patients who are homozygous for ClC-Ka Arg/Arg 83 allele
|
Drug: Eplerenone
Eplerenone 50 mg/day
Other Names:
|
Placebo Comparator: Arm 3
Caucasian hypertensive patients who are homozygous for ClC-Ka Arg/Arg 83 allele
|
Drug: placebo
placebo
|
Placebo Comparator: Arm 4
Caucasian hypertensive patients who are homozygous for the ClC-Ka Gly/Gly83 allele
|
Drug: placebo
placebo
|
- Change in LV mass index (g/m2) in ClC-Ka Gly/Gly83 patients and ClC-Ka Gly/Gly83 patients [ Time Frame: 12 months ]
- Change in LV relative wall thickness [ Time Frame: 6 and 12 months ]
- Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: 6 and 12 months ]
- Change in LV mass index (g/m2) [ Time Frame: 6 months ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Caucasians with hypertension who are homozygous for the ClC-Ka Gly/Gly83 and the ClC-Ka Arg/Arg 83 allele.
- Male or non-pregnant female aged 40 to 80 years.
- Hypertension, defined as currently taking high blood pressure medications or not on medications but having SDP >140 or DBP >90.
- Ejection fraction > 50% by any method within 6 months of the screening visit.
- The Investigator must obtain written informed consent before the subject is screened for the study.
- Subject should be on stable dose of ACE or ARB at moderate dosing for at least 4 weeks before randomization.
Exclusion Criteria:
- History of heart failure with preserved or depressed ejection fraction.
- Creatinine clearance of < 45 mL/min based on the Cockcroft-Gault formula (Appendix C).
- Pregnancy
- Life expectancy less than 12 months.
- Planned cardiac surgery or percutaneous cardiac intervention within 3 months.
- Serum potassium >5.5 mEq/L.
- History of hyperkalemia (K>6.0 mEq/L) with eplerenone or spironolactone.
- Myocardial infarction or stroke within 3 months of screening.
- Evidence of clinical instability (hypotension, arrhythmias, unstable angina etc.).
- Subjects on or requiring K-sparing diuretics or spironolactone.
- Concomitant use of potent inhibitors of CYP3A4 including ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir or any drug noted in the Contraindications, Warnings or Precautions sections of their labeling to be potent CYP3A4 inhibitors
- Known hypersensitivity to eplerenone or spironolactone.
- Evidence of current alcohol or drug abuse Severe organic disorders or surgery or disease of the gastrointestinal tract that in the opinion of the Investigator may interfere in the absorption and elimination of the study drug.
- Psychoses or behavioral conditions that in the opinion of the Investigator would limit study compliance.
- Subjects who have received any investigational medication or used any investigational device within 30 days prior to first dose of study drug or subjects actively participating in any investigational drug or device study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275352
United States, Missouri | |
Barnes Jewish Hospital | |
St. Louis, Missouri, United States, 63108 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Thomas Cappola, MD | University of Pennsylvania | |
Principal Investigator: | Gerald Dorn, MD | Washington University School of Medicine |
Responsible Party: | Thomas Cappola, MD, ScM, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01275352 History of Changes |
Other Study ID Numbers: |
CLNCKA-1 |
First Posted: | January 12, 2011 Key Record Dates |
Last Update Posted: | June 3, 2015 |
Last Verified: | June 2015 |
Keywords provided by Washington University School of Medicine:
left ventricular hypertrophy heart failure |
Additional relevant MeSH terms:
Hypertrophy Pathological Conditions, Anatomical Eplerenone Spironolactone Mineralocorticoid Receptor Antagonists Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents |