Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
Completed · Phase 4 · Has a placebo group
Conditions studied: Long QT Syndrome, Abnormalities, Drug-Induced
In brief
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 testosterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in men 65 years of age or older. This investigation will consist of two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies in a) Postmenopausal women, and b) Men 65 years of age or older. Study 1: Each postmenopausal woman will take progesterone or placebo capsules for 1 week. After a 14-day "washout" (no progesterone or placebo) each subject will then take the alternative therapy (progesterone or placebo) for 1 week. After 7 days of each treatment, subjects will present to the clinical research center to receive a small dose of the QT interval-lengthening drug ibutilide, and the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the progesterone and placebo phases will be compared. Study 2: Each man 65 years of age or older will apply transdermal testosterone or transdermal placebo gel for 3 days. After a 7-day "washout" (no testosterone or placebo) each subject will then apply the alternative therapy (testosterone or placebo gel) for 1 week. After 3 days of each treatment, subjects will present to the clinical research center to receive a small dose of the QT interval-lengthening drug ibutilide, and the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the testosterone and placebo phases will be compared.
Key facts
- Study ID
- NCT04675788
- Run by
- Indiana University
- People needed
- 73
- Starts
- 2021-09-02
- Expected to finish
- 2025-04-16
- Last updated by the study team
- 2026-03-19
Who can join
Age: 50 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Postmenopausal Women:
- Age 50-99 years old
- Postmenopausal (have not has a menstrual period for 12 months or longer)
You may not qualify if…
- 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:
Where it is running
- Indiana Clinical Research Center — Indianapolis, Indiana, United States
- Indiana University — Indianapolis, Indiana, United States
- Purdue University — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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