Reducing the Risk of Drug-Induced QT Interval Lengthening in Women (NCT03834883) | Clinical Trial Compass
CompletedPhase 4
Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
United States27 participantsStarted 2019-03-26
Plain-language summary
This research will determine if oral progesterone attenuates drug-induced QT interval lengthening in a) Postmenopausal women 50 years of age or older, and b) Premenopausal women studied during the ovulation phase of the menstrual cycle. This investigation will consist of two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies in a) Postmenopausal women, and b) Premenopausal women. Each subject will take progesterone or placebo capsules for 1 week. After a two-week "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
Who can participate
Age range
21 Years
Sex
FEMALE
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:
* 50 years of age or older
* No menstrual periods for 365 days or longer
Premenopausal women:
\- 21-40 years of age
Exclusion Criteria:
* History of breast, uterine or ovarian cancer
* History of hysterectomy and/or ovariectomy
* Weight \> 135 kg
* Serum K+ \< 3.6 mEq/L;
* Serum Mg2+ \< 1.8 mg/dL;
* Hematocrit \< 26%;
* Hepatic transaminases \> 3x upper limit of normal;
* Baseline Bazett's-corrected QT interval \> 450 ms
* Taking hormone replacement therapy
* Diagnosis of heart failure
* Symptoms associated with heart failure:
* Pitting edema \> 2+
* Crackles or rales on lung auscultation
* S3 or S4 heart sounds
* Unable to climb at least 2 flights of stairs without becoming short of breath
* Current ECG rhythm of atrial fibrillation or other tachyarrhythmia
* Family or personal history of long-QT syndrome or sudden cardiac death not associated with acute myocardial infarction
* Concomitant use of any QTc interval-prolonging drug.
* Permanently paced ventricular rhythm
* Pregnancy
* Using any hormonal contraceptives \[oral contraceptives, hormone-secreting intrauterine devices (IUDs), hormonal implants\]
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
1
Baseline (Pre-ibutilide) QT-F Intervals
Timeframe: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
2
Maximum Post-ibutilide QT-F Intervals
Timeframe: Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
3
% Change From Baseline (Pre-ibutilide) in Maximum QT-F Intervals
Timeframe: Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
4
Area Under the QT-F Versus Time Curves During and for 1 Hour Following Ibutilide Infusion
Timeframe: Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion