Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 31 for:    "Preeclampsia/eclampsia 1" | "Antihypertensive Agents"

ToRsemide for pOstpartum HYpertension (TROPHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813551
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Oscar Andres Viteri Molina, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Preeclampsia
Interventions Drug: Torsemide
Drug: Placebo
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description Torsemide 20 mg daily for 5 days Placebo 20 mg daily for 5 days
Period Title: Overall Study
Started 59 59
Completed 58 57
Not Completed 1 2
Arm/Group Title Torsemide Placebo Total
Hide Arm/Group Description Torsemide 20 mg daily for 5 days Placebo 20 mg daily for 5 days Total of all reporting groups
Overall Number of Baseline Participants 59 59 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 59 participants 118 participants
26.9  (6.1) 28.2  (6.8) 27.6  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
Female
59
 100.0%
59
 100.0%
118
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
Hispanic or Latino
16
  27.1%
13
  22.0%
29
  24.6%
Not Hispanic or Latino
43
  72.9%
46
  78.0%
89
  75.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 59 participants 59 participants 118 participants
Black or African American
33
  55.9%
35
  59.3%
68
  57.6%
Caucasian
9
  15.3%
11
  18.6%
20
  16.9%
Hispanic
16
  27.1%
13
  22.0%
29
  24.6%
Other
1
   1.7%
0
   0.0%
1
   0.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 59 participants 59 participants 118 participants
59
 100.0%
59
 100.0%
118
 100.0%
Body Mass Index (BMI) at delivery  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 59 participants 59 participants 118 participants
38.3  (10.4) 37.0  (9.9) 37.7  (10.2)
Married  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
21
  35.6%
20
  33.9%
41
  34.7%
Nulliparous  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
38
  64.4%
31
  52.5%
69
  58.5%
Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
1
   1.7%
5
   8.5%
6
   5.1%
Use of illicit drugs  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
6
  10.2%
5
   8.5%
11
   9.3%
Use of Cocaine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
1
   1.7%
0
   0.0%
1
   0.8%
Prenatal care  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
59
 100.0%
55
  93.2%
114
  96.6%
Form of Payment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
Government/Subsidized Insurance
46
  78.0%
44
  74.6%
90
  76.3%
Private Insurance
12
  20.3%
14
  23.7%
26
  22.0%
None/Self Paid
1
   1.7%
1
   1.7%
2
   1.7%
Pregestational Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
7
  11.9%
6
  10.2%
13
  11.0%
Gestational Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
5
   8.5%
5
   8.5%
10
   8.5%
Chronic Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
15
  25.4%
15
  25.4%
30
  25.4%
Asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
4
   6.8%
12
  20.3%
16
  13.6%
1.Primary Outcome
Title Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
Hide Description 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.
Time Frame 0-5 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Measure Type: Count of Participants
Unit of Measure: Participants
26
  44.1%
34
  57.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Torsemide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.53 to 1.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)
Hide Description [Not Specified]
Time Frame 0-6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Measure Type: Count of Participants
Unit of Measure: Participants
7
  11.9%
6
  10.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Torsemide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.4 to 3.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Requiring Postpartum Readmission
Hide Description [Not Specified]
Time Frame 0-6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.1%
1
   1.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Torsemide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
0.3 to 28
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Length of Hospital Stay After Delivery
Hide Description [Not Specified]
Time Frame 0-5 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Median (Inter-Quartile Range)
Unit of Measure: hours
68
(52 to 94)
54
(47 to 77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Torsemide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
1.0 to 1.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Weight Change
Hide Description [Not Specified]
Time Frame at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: pounds
3.01  (3.85) 2.08  (2.69)
6.Secondary Outcome
Title Change in Lower Extremity Edema
Hide Description Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.
Time Frame at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: millimeters
-1.29  (12.08) -2.9  (14.08)
7.Secondary Outcome
Title Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Hide Description [Not Specified]
Time Frame 7-10 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
38 (42%) women in the torsemide group and 31 (53%) women in the placebo missed their outpatient clinic visit at 7-10 days after delivery, resulting in only 21 in the torsemide group and 28 in the placebo group being analyzed.
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 21 28
Measure Type: Count of Participants
Unit of Measure: Participants
9
  42.9%
11
  39.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Torsemide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
1.0 to 1.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Hide Description [Not Specified]
Time Frame 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
36 women in the torsemide group and 28 women in the placebo group did not show to their clinic appointment 6 weeks after delivery, resulting in 23 in the torsemide group and 31 in the placebo group being analyzed.
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 23 31
Measure Type: Count of Participants
Unit of Measure: Participants
8
  34.8%
11
  35.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Torsemide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.5 to 1.9
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)
Hide Description [Not Specified]
Time Frame 0-5 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group.
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 22 31
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.5%
4
  12.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Torsemide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.1 to 2.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Side Effects of Therapy - Decreased Breast Milk
Hide Description [Not Specified]
Time Frame 0-5 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.7%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Severe Composite Maternal Morbidity
Hide Description 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.
Time Frame 0-6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description:
Torsemide 20 mg daily for 5 days
Placebo 20 mg daily for 5 days
Overall Number of Participants Analyzed 59 59
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Other Pre-specified Outcome
Title Torsemide Concentrations in Breast Milk
Hide Description Ancillary study
Time Frame 0-5 days after delivery
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Electrolyte Profile in Maternal Serum
Hide Description Concentrations of: Sodium, Potassium, Calcium
Time Frame 0-5 days after delivery
Outcome Measure Data Not Reported
Time Frame 6 weeks
Adverse Event Reporting Description Only related adverse events were recorded. Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group, thus only 22 in the torsemide group and 31 in the placebo group are indicated as at risk for hypokalemia.
 
Arm/Group Title Torsemide Placebo
Hide Arm/Group Description Torsemide 20 mg daily for 5 days Placebo 20 mg daily for 5 days
All-Cause Mortality
Torsemide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)      0/59 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Torsemide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      0/59 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Torsemide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/59 (3.39%)      4/59 (6.78%)    
General disorders     
Hypokalemia (low blood potassium levels)   1/22 (4.55%)  1 4/31 (12.90%)  4
Pregnancy, puerperium and perinatal conditions     
Decreased breast milk   1/59 (1.69%)  1 0/59 (0.00%)  0
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Oscar Andres Viteri Molina, MD
Organization: The University of Texas Health Science Center at Houston
Phone: (713) 500-6412
EMail: Oscar.A.ViteriMolina@uth.tmc.edu
Layout table for additonal information
Responsible Party: Oscar Andres Viteri Molina, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02813551     History of Changes
Other Study ID Numbers: HSC-MS-16-0198
First Submitted: June 19, 2016
First Posted: June 27, 2016
Results First Submitted: July 27, 2018
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019