ToRsemide for pOstpartum HYpertension

NCT02813551 | Completed Phase 2 Results DMC

• 1 other identifier: HSC-MS-16-0198
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

Preeclampsia, puerperium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

  at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)

Other Outcomes (2)

• Torsemide Concentrations in Breast Milk

  0-5 days after delivery

• Electrolyte Profile in Maternal Serum

  0-5 days after delivery

Study Arms (2)

Torsemide

EXPERIMENTAL

Torsemide 20 mg daily for 5 days

Drug: Torsemide

Placebo

PLACEBO COMPARATOR

Placebo 20 mg daily for 5 days

Drug: Placebo

Interventions

Torsemide DRUG

Also known as: Demadex, torasemide

Torsemide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 30303905 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Torsemide

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Median hospital stay \<3 days, but sample size powered to detect differences in up to 5 days. High rate of clinic no-shows. Not powered to detect differences in secondary outcomes. Edema measurements done with stocking, which may affect reliability.

Results Point of Contact

• Title: Oscar Andres Viteri Molina, MD
• Organization: The University of Texas Health Science Center at Houston

Oscar.A.ViteriMolina@uth.tmc.edu

(713) 500-6412

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal-Fetal Medicine Fellow

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: June 27, 2016
• Study Start: August 1, 2016
• Primary Completion: July 28, 2017
• Study Completion: September 9, 2017
• Last Updated: April 10, 2019
• Results First Posted: April 10, 2019

Record last verified: 2019-03

Locations

US (1)