PreeclampsiaPhase 2TROPHYNCT02813551

ToRsemide for pOstpartum HYpertension

A Phase 2 study testing Torsemide in people with Preeclampsia, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Preeclampsia
What is being tested?: Torsemide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 118 participants
Where: 1 siteUnited States
Study dates: Aug 2016to 9 Sep 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center
Houston, Texas, 77030

Other trials in United States

About this study

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

Conditions: Preeclampsia
Being tested: Torsemide, Placebo
Keywords: Preeclampsia, puerperium
Medical subject headings: Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TorsemideDrug
Also called Demadex, torasemide
PlaceboDrug

Study groups in NCT02813551
Study group	Role	What they receive
Torsemide	Experimental	Torsemide 20 mg daily for 5 days Receives: Drug: Torsemide
Placebo	Placebo comparator	Placebo 20 mg daily for 5 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Measured: 0-6 weeks after delivery
Number of Participants Requiring Postpartum Readmission
Measured: 0-6 weeks after delivery
Length of Hospital Stay After Delivery
Measured: 0-5 days after delivery
Weight Change
Measured: 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.
Measured: 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)
Measured: 7-10 days after delivery
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Measured: 6 weeks after delivery
Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)
Measured: 0-5 days after delivery
Number of Participants With Side Effects of Therapy - Decreased Breast Milk
Measured: 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.
Measured: 0-6 weeks after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20169 Sep 2017

First posted27 Jun 2016 (estimated)
Study startAug 2016
Primary completion28 Jul 2017
Study completion9 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PreeclampsiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02813551
Sponsor's protocol ID: HSC-MS-16-0198
Acronym: TROPHY
Status last verified: Mar 2019
First submitted: 19 Jun 2016
Last updated: 10 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

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.
PubMed 30303905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingEarly Phase 1
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Preeclampsia, Endothelial Function
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Active, not recruitingEarly Phase 1
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
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Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia

All Preeclampsia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial
ClinicalTrials.gov ID: NCT02813551
Acronym / sponsor ID: TROPHY / HSC-MS-16-0198
Conditions: Preeclampsia
Keywords: Preeclampsia, puerperium
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Aug 2016
Primary completion: 28 Jul 2017 (actual)
Study completion: 9 Sep 2017 (actual)
First posted: 27 Jun 2016 (estimated)
Results: Posted 10 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Torsemide	Experimental	Drug: TorsemideTorsemide 20 mg daily for 5 days
Placebo	Placebo comparator	Drug: PlaceboPlacebo 20 mg daily for 5 days

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TorsemideAlso: Demadex, torasemide	Drug	Torsemide
Placebo	Drug	Placebo

Primary outcome

Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
Time frame: 0-5 days after delivery
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.

10 secondary outcomes

Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)
Time frame: 0-6 weeks after delivery
Number of Participants Requiring Postpartum Readmission
Time frame: 0-6 weeks after delivery
Length of Hospital Stay After Delivery
Time frame: 0-5 days after delivery
Weight Change
Time frame: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
Change in Lower Extremity Edema
Time frame: 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)
Time frame: 7-10 days after delivery
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Time frame: 6 weeks after delivery
Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)
Time frame: 0-5 days after delivery
Number of Participants With Side Effects of Therapy - Decreased Breast Milk
Time frame: 0-5 days after delivery
Number of Participants With Severe Composite Maternal Morbidity
Time frame: 0-6 weeks after delivery

Results and safety

Results posted to the registry on 10 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Torsemide	59	58
Placebo	59	57

Primary outcome: Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg

Time frame: 0-5 days after delivery. Count of participants. Unit: Participants

Measure	Torsemide n = 59	Placebo n = 59
Value	26	34

Torsemide vs Placebo: Risk Ratio (RR): 0.76 (95% CI 0.53 to 1.10)

Population analysed: Intention-to-treat

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Torsemide	0 of 59 (0%)	2 of 59 (3.4%)	0 of 59
Placebo	0 of 59 (0%)	4 of 59 (6.8%)	0 of 59

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30303905Viteri 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.
Individual participant dataSharing planned: Undecided

Related trials for Preeclampsia

RecruitingEarly Phase 1
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Preeclampsia, Endothelial Function
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Active, not recruitingEarly Phase 1
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Preeclampsia Postpartum
Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Torsemide in people with Preeclampsia, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg (time frame: 0-5 days after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02813551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.