Status:
COMPLETED
Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
Lead Sponsor:
Indiana University
Collaborating Sponsors:
American Heart Association
Purdue University
Conditions:
Long QT Syndrome
Abnormalities, Drug-Induced
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief 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 ovu...
Detailed Description
Torsades de pointes (TdP) is a catastrophic arrhythmia associated with corrected QT (QTc) interval prolongation, which can be induced by \> 150 commonly prescribed drugs. TdP risk is higher in women a...
Eligibility Criteria
Inclusion
- Postmenopausal women:
- 50 years of age or older
- No menstrual periods for 365 days or longer
- Premenopausal women:
- \- 21-40 years of age
Exclusion
- 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 \[oral contraceptives, hormone-secreting intrauterine devices (IUDs), hormonal implants\]
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03834883
Start Date
March 26 2019
End Date
May 23 2024
Last Update
July 1 2025
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202