Status:
COMPLETED
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Purdue University
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Long QT Syndrome
Abnormalities, Drug-Induced
Eligibility:
All Genders
50-99 years
Phase:
PHASE4
Brief Summary
This research will determine if: 1) Oral progesterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in postmenopausal women 50 years of age or older, and 2) Transdermal testo...
Detailed Description
Torsades de pointes (TdP) is a ventricular tachycardia associated with prolongation of the corrected QT (QTc) interval, and which may be caused by \> 150 widely used drugs. TdP results in catastrophic...
Eligibility Criteria
Inclusion
- Postmenopausal Women:
- Age 50-99 years old
- Postmenopausal (have not has a menstrual period for 12 months or longer)
Exclusion
- Postmenopausal women:
- Subject reported history of breast, uterine and ovarian cervical cancer
- Subject reported history of hysterectomy and/or ovariectomy
- Subject reported taking any hormone replacement therapy (prescription, nonprescription or herbal supplement)
- Weight \< 60 kg at time of screening visit
- Weight \>135 kg at time of screening visit
- Serum K+ \<3.6 mEq/L at time of any ibutilide dosing visit
- Serum Mg2+ \<1.8 mg/dL at time of screening visit
- Hematocrit \<26%
- AST or ALT \> 3x the upper limit of normal (determined by testing lab ranges) at the time of screening visit
- Baseline Bazett's-corrected QTc \>450 ms (during any visit prior to ibutilide dosing)
- Baseline QRS \> 120 ms (at time of baseline visit)
- Diagnosis of heart failure due to reduced or preserved ejection fraction
- Subject reported family history of long QT syndrome, TdP, or sudden cardiac death not associated with acute myocardial infarction
- Self-reported personal history of long QT syndrome, sudden cardiac death not associated with acute myocardial infarction
- Subject reported history any prolonged arrhythmia for which treatment was required
- Subject reported history of a myocardial infarction
- Subject reported history of coronary artery disease
- Sustained arrythmia found at baseline screening prior to any study visit including atrial fibrillation, atrial flutter, junctional rhythm, heart block (any)
- Permanently paced ventricular rhythm
- Current reported use of any QT prolonging medication. Investigator will check the current QT drugs list at www.crediblemeds.org during screening.
- Current reported use of any moderate or strong inhibitors of cytochrome P450 (CYP) 3A4, 3A5, or 3A7
- Current reported use of any inducers of cytochrome P-450 (CYP) 3A4, 3A5 or 3A7
- Inclusion Criteria:
- Older Men:
- • Age 65 years old to 99 years old
Key Trial Info
Start Date :
September 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04675788
Start Date
September 2 2021
End Date
April 16 2025
Last Update
April 29 2025
Active Locations (3)
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1
Indiana Clinical Research Center
Indianapolis, Indiana, United States, 46202
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
Purdue University
Indianapolis, Indiana, United States, 46202