CompletedPhase 4

Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

United States73 participantsStarted 2021-09-02

Plain-language 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 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.

Who can participate

Age range

50 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Postmenopausal Women: * Age 50-99 years old * Postmenopausal (have not has a menstrual period for 12 months or longer) Exclusion Criteria: 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 v…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pre-ibutilide QT-F and QT-Fram intervals

Timeframe: Morning of day 8 (after 7 days of progesterone/placebo)

Pre-ibutilide QT-F and QT-Fram intervals

Timeframe: Morning of day 4 (after 3 days of testosterone/placebo)

Maximum post-ibutilide QT-F and QT-Fram intervals

Timeframe: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion

Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals

Timeframe: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion

Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion

Timeframe: From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion

Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion

Timeframe: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion

Trial details

NCT IDNCT04675788

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-16

View on ClinicalTrials.gov More Long QT Syndrome trials

Plain-language summary

Who can participate

Age range

50 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pre-ibutilide QT-F and QT-Fram intervals

Timeframe: Morning of day 8 (after 7 days of progesterone/placebo)

Pre-ibutilide QT-F and QT-Fram intervals

Timeframe: Morning of day 4 (after 3 days of testosterone/placebo)

Maximum post-ibutilide QT-F and QT-Fram intervals

Timeframe: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion

Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals

Timeframe: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion

Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion

Timeframe: From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion

Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion

Timeframe: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion