ToRsemide for pOstpartum HYpertension (TROPHY)

Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Placebo; Drug: Torsemide

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Torsemide; Torsemide 20 mg daily for 5 days	Drug: Torsemide; Other Names: Demadex, torasemide
Placebo Comparator: Placebo; Placebo 20 mg daily for 5 days	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg	Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first.	0-5 days after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)		0-6 weeks after delivery
Number of Participants Requiring Postpartum Readmission		0-6 weeks after delivery
Length of Hospital Stay After Delivery		0-5 days after delivery
Weight Change		at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
Change in Lower Extremity Edema	Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.	at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)		7-10 days after delivery
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)		6 weeks after delivery
Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)		0-5 days after delivery
Number of Participants With Side Effects of Therapy - Decreased Breast Milk		0-5 days after delivery
Number of Participants With Severe Composite Maternal Morbidity	Severe composite maternal morbidity is defined as having any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy, or maternal death.	0-6 weeks after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Torsemide Concentrations in Breast Milk	Ancillary study	0-5 days after delivery
Electrolyte Profile in Maternal Serum	Concentrations of: Sodium, Potassium, Calcium	0-5 days after delivery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Viteri OA, Alrais MA, Pedroza C, Hutchinson M, Chauhan SP, Blackwell SC, Sibai BM. Torsemide for Prevention of Persistent Postpartum Hypertension in Women With Preeclampsia: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1185-1191. doi: 10.1097/AOG.0000000000002941.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): September 9, 2017

Study Registration Dates

• First Submitted: June 19, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Preeclampsia, puerperium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Hypertension; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Torsemide
• Other Study ID Numbers: HSC-MS-16-0198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided