ToRsemide for pOstpartum HYpertension (TROPHY)

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Preeclampsia

Treatments: Drug: Placebo; Drug: Torsemide

Study type: Interventional

Funder types: Other

Identifiers

NCT02813551

HSC-MS-16-0198

Details and patient eligibility

About

Currently there is no intervention to prevent persistent postpartum hypertension in preeclamptic women. Physiologically, the use of a pharmacokinetically predictable loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the incidence of persistent postpartum hypertension in preeclamptic women.

Enrollment: 118 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postpartum women at ≥ 18 years of age
• Antepartum/intrapartum or within 24 hours postpartum diagnosis of either:
• Preeclampsia
• Preeclampsia with severe features
• Preeclampsia superimposed to chronic hypertension

Exclusion criteria

• Chronic hypertension without superimposed preeclampsia
• Gestational hypertension
• Urine output < 30 cc/h at time of randomization
• Heart failure or pulmonary edema
• Hypersensitivity to Torsemide or sulfonylureas
• Hypokalemia (serum potassium < 3 mEq/L)
• Preexisting diuretic use within 24 hours prior to randomization

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups, including a placebo group

Torsemide

Experimental group

Description:

Torsemide 20 mg daily for 5 days

Treatment:

Drug: Torsemide

Placebo

Placebo Comparator group

Description:

Placebo 20 mg daily for 5 days

Treatment:

Drug: Placebo