Hypertension, Pregnancy-InducedPhase 4NCT04343235
Postpartum Management of Gestational Hypertensive Disorders Using Furosemide
A Phase 4 study testing furosemide and labetalol in people with Hypertension, Pregnancy-Induced, run by Wright State University at 1 site in United States.
Trial summary
The main purpose of this study is to learn if incorporating a loop diuretic such as furosemide along with labetalol in the routine management of postpartum gestational hypertensive disorders could lower the need for additional anti-hypertensive agents to control blood pressures, improve blood pressures (as measured by… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced
- What is being tested?
- furosemide and labetalol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 30 Jun 2022
- Phase
- Phase 4
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum women delivering at Miami Valley Hospital
- Diagnosis of gestational hypertension or preeclampsia
- Able to provide written informed consent
Who cannot join
- Diagnosis of chronic hypertension
- Allergy to study medications
- Unable to understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postpartum Management of Gestational Hypertensive Disorders Using Furosemide: A Randomized Controlled Trial
- The main purpose of this study is to learn if incorporating a loop diuretic such as furosemide along with labetalol in the routine management of postpartum gestational hypertensive disorders could lower the need for additional anti-hypertensive agents to control blood pressures, improve blood pressures (as measured by systolic blood pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital stays and decrease readmissions for patients with gestational hypertensive disorders.
- Based on a study by Veena et al1, there is reason to believe that the addition of furosemide to other anti-hypertensives may help decrease the need to add or increase the dose of medication to control blood pressures. There may be potential to shorten hospital stays and decrease readmissions, as well. Collecting data will be done using a prospective, randomized 1:1 controlled study assigning postpartum patients with a gestational hypertensive diagnosis to either labetalol alone or labetalol plus furosemide.
- The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus and would use patients who have consented to participate in the study with enrollees coming from the OB Staff population.
Read the detailed description
Background and Literature Review
- There have been four documented studies investigating loop diuretics in the management of postpartum hypertensive disorders- Matthews et al2, Ascarelli et al3, Amorim et al4, and Veena et al. Of these studies, only Amorim and Veena were able to show statistical significance on any parameters. Amorim was able to show that there was an improvement of SBP, DBP and MAP, but the research was only presented as an abstract at a conference and not published, thereby making it impossible to draw any conclusions or practice guidelines. Veena demonstrated that by using furosemide and nifedipine in combination, the need for additional antihypertensive medication in severe pre-eclampsia in the postpartum period was reduced when compared to nifedipine alone.
- A systematic review5 of postpartum hypertensive disorder management suggested that there was insufficient data to recommend any single pharmacological intervention at this time in the management of gestational hypertensive disorders. The review emphasized the need for further studies to be conducted to help guide management of patients affected by gestational hypertensive disorders in the future.
Objectives
● Main Question
- Does the use of furosemide plus labetalol improve blood pressures in the postpartum period of patients with gestational hypertensive disorders versus labetalol alone?
- Primary ■ Will there be a requirement to escalate antihypertensive therapy to control blood pressures
- Secondary
- Improvement of gestational hypertensive disorders by measurement of systolic blood pressure, diastolic blood pressure and mean arterial pressure
- Shortened hospital stay in patients with hypertensive disorders
- Breastfeeding status at 1 week postpartum visit in mothers planning to breastfeed
- Readmission for postpartum hypertensive disorders
Significance to patient, institution, and profession
- As a referral center and being the region's leader, Miami Valley is very accustomed to accepting transfers of high acuity patients often times with hypertensive disorders being the root cause of the transport
- The majority of the OB staff population being served at Miami Valley Hospital is African American. According to Myatt6, the incidence of pre-eclampsia in the African American population is greater than double the Caucasian population (11% to 5%) thereby making this study very applicable to the patient population served at Miami Valley Hospital.
- With the construct of the study, costs abe kept low by utilizing already established resources and practices (blood pressure cuffs, nurses, routine one week blood pressure checks) while only adding on the unit cost of furosemide.
- If treatment with labetalol and furosemide is found to be useful, it would be not only a very inexpensive, cost effective way of improving patient outcomes and possibly decreasing lengths of stay stateside, but in improving global practice in places that are lacking in resources privy to first world countries.
Methods
- The study would be designed as:
- A prospective randomized 1:1 controlled trial including postpartum women with gestational hypertension or preeclampsia
- Patients with chronic hypertension would be excluded from the study
- One arm receiving 200mg labetalol BID alone on PPD#1 or 24 hours after magnesium sulfate
- One arm receiving 200mg labetalol BID and a five day course of furosemide 20mg QD on PPD#1 or 24 hours after magnesium sulfate
- Recording any occurrence when an increased amount of labetalol is needed to maintain blood pressures below 150 SBP and/or 100 DBP per ACOG recommendations.7 ■ In the event of persistently elevated blood pressures, labetalol will be increased to 400mg TID and escalated to 600mg TID and finally 800mg TID as indicated
- Measurement of blood pressure every four hours after administration until patient discharge
- Measurement of urine output every 12 hours until discharge
- Compare average systolic, diastolic and mean arterial pressures between the two groups during admission and at one week postpartum
- Data will be collected using the OB Staff population at Miami Valley Hospital Main Campus.
- The research will be analyzed and interpreted by the research team conducting the study.
- Potential difficulties and limitations include compliance concerns of mandatory one week blood pressure follow up appointment.
- Using the Veena et al paper as a frame of reference, a sample size of 140 divided evenly across the two treatment arms would achieve statistical significance in determining the need to escalate anti-hypertensive therapy.
- The unit cost of one tablet of labetalol 200mg and furosemide 20mg is currently $0.32 and $1.23, respectively. 8,9
- The study would use already readily available automated blood pressure cuff machines on the postpartum wing.
- Conditions
- Hypertension, Pregnancy-Induced
- Being tested
- furosemide, labetalol
- Keywords
- pregnancy induced hypertension, preeclampsia, furosemide
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemideDrug
Also called lasix
five day course of furosemide 20mg QD
labetalolDrug
Also called trandate
200mg labetalol BID
| Study group | Role | What they receive |
|---|---|---|
| labetalol + furosemide | Experimental | labetalol + furosemide Receives: Drug: furosemide; Drug: labetalol |
| labetalol only | Active comparator | labetalol only Receives: Drug: labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Dose for Antihypertensive Therapy
number of patients who require a change in the dose of labetalol to control BP
Measured: Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)
Secondary outcomes (6)
Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)
average systolic blood pressure reading on Day 0, Day 1, and Day 2
Measured: Average systolic blood pressure for Day 0, Day 1, and Day 2
Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)
average mean arterial pressure reading on Day 0, Day 1, and Day 2
Measured: Average mean arterial pressure on Day 0, Day 1, and Day 2
Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)
average diastolic blood pressure reading on Day 0, Day 1, and Day 2
Measured: Average diastolic blood pressure on Day 0, Day 1, and Day 2
Hospital Length of Stay
days in hospital after delivery
Measured: Number of days of hospital stay from randomization to discharge
Breastfeeding Status
breastfeeding continuation after discharge
Measured: at 1 week postpartum visit
Hospital Readmission
readmission for hypertension management
Measured: up to 14 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 May 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Challenges with enrollment; primary investigator left the institution
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 (6)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy-InducedStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheela Barhan, MD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343235
- Sponsor's protocol ID
- 06784
- Status last verified
- Sep 2023
- First submitted
- 28 Oct 2019
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared on a case by case basis
Publications
Veena P, Perivela L, Raghavan SS. Furosemide in postpartum management of severe preeclampsia: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):84-89. doi: 10.1080/10641955.2016.1239735. Epub 2016 Nov 11.
PubMed 27835048Matthews G, Gornall R, Saunders NJ. A randomised placebo controlled trial of loop diuretics in moderate/severe pre-eclampsia, following delivery. J Obstet Gynaecol. 1997 Jan;17(1):30-2. doi: 10.1080/01443619750114040.
PubMed 15511760Ascarelli MH, Johnson V, McCreary H, Cushman J, May WL, Martin JN Jr. Postpartum preeclampsia management with furosemide: a randomized clinical trial. Obstet Gynecol. 2005 Jan;105(1):29-33. doi: 10.1097/01.AOG.0000148270.53433.66.
PubMed 15625138Cairns AE, Pealing L, Duffy JMN, Roberts N, Tucker KL, Leeson P, MacKillop LH, McManus RJ. Postpartum management of hypertensive disorders of pregnancy: a systematic review. BMJ Open. 2017 Nov 28;7(11):e018696. doi: 10.1136/bmjopen-2017-018696.
PubMed 29187414Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Iams JD, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012 Jun;119(6):1234-42. doi: 10.1097/AOG.0b013e3182571669.
PubMed 22617589Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Management of Gestational Hypertensive Disorders Using Furosemide: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04343235
- Acronym / sponsor ID
- 06784
- Conditions
- Hypertension, Pregnancy-Induced
- Keywords
- pregnancy induced hypertension, preeclampsia, furosemide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges with enrollment; primary investigator left the institution
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The main purpose of this study is to learn if incorporating a loop diuretic such as furosemide along with labetalol in the routine management of postpartum gestational hypertensive disorders could lower the need for additional anti-hypertensive agents to control blood pressures, improve blood pressures (as measured by systolic blood pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital stays and decrease readmissions for patients with gestational hypertensive disorders.
- Based on a study by Veena et al1, there is reason to believe that the addition of furosemide to other anti-hypertensives may help decrease the need to add or increase the dose of medication to control blood pressures. There may be potential to shorten hospital stays and decrease readmissions, as well. Collecting data will be done using a prospective, randomized 1:1 controlled study assigning postpartum patients with a gestational hypertensive diagnosis to either labetalol alone or labetalol plus furosemide.
- The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus and would use patients who have consented to participate in the study with enrollees coming from the OB Staff population.
Detailed description
Background and Literature Review
- There have been four documented studies investigating loop diuretics in the management of postpartum hypertensive disorders- Matthews et al2, Ascarelli et al3, Amorim et al4, and Veena et al. Of these studies, only Amorim and Veena were able to show statistical significance on any parameters. Amorim was able to show that there was an improvement of SBP, DBP and MAP, but the research was only presented as an abstract at a conference and not published, thereby making it impossible to draw any conclusions or practice guidelines. Veena demonstrated that by using furosemide and nifedipine in combination, the need for additional antihypertensive medication in severe pre-eclampsia in the postpartum period was reduced when compared to nifedipine alone.
- A systematic review5 of postpartum hypertensive disorder management suggested that there was insufficient data to recommend any single pharmacological intervention at this time in the management of gestational hypertensive disorders. The review emphasized the need for further studies to be conducted to help guide management of patients affected by gestational hypertensive disorders in the future.
Objectives
● Main Question
- Does the use of furosemide plus labetalol improve blood pressures in the postpartum period of patients with gestational hypertensive disorders versus labetalol alone?
- Primary ■ Will there be a requirement to escalate antihypertensive therapy to control blood pressures
- Secondary
- Improvement of gestational hypertensive disorders by measurement of systolic blood pressure, diastolic blood pressure and mean arterial pressure
- Shortened hospital stay in patients with hypertensive disorders
- Breastfeeding status at 1 week postpartum visit in mothers planning to breastfeed
- Readmission for postpartum hypertensive disorders
Significance to patient, institution, and profession
- As a referral center and being the region's leader, Miami Valley is very accustomed to accepting transfers of high acuity patients often times with hypertensive disorders being the root cause of the transport
- The majority of the OB staff population being served at Miami Valley Hospital is African American. According to Myatt6, the incidence of pre-eclampsia in the African American population is greater than double the Caucasian population (11% to 5%) thereby making this study very applicable to the patient population served at Miami Valley Hospital.
- With the construct of the study, costs abe kept low by utilizing already established resources and practices (blood pressure cuffs, nurses, routine one week blood pressure checks) while only adding on the unit cost of furosemide.
- If treatment with labetalol and furosemide is found to be useful, it would be not only a very inexpensive, cost effective way of improving patient outcomes and possibly decreasing lengths of stay stateside, but in improving global practice in places that are lacking in resources privy to first world countries.
Methods
- The study would be designed as:
- A prospective randomized 1:1 controlled trial including postpartum women with gestational hypertension or preeclampsia
- Patients with chronic hypertension would be excluded from the study
- One arm receiving 200mg labetalol BID alone on PPD#1 or 24 hours after magnesium sulfate
- One arm receiving 200mg labetalol BID and a five day course of furosemide 20mg QD on PPD#1 or 24 hours after magnesium sulfate
- Recording any occurrence when an increased amount of labetalol is needed to maintain blood pressures below 150 SBP and/or 100 DBP per ACOG recommendations.7 ■ In the event of persistently elevated blood pressures, labetalol will be increased to 400mg TID and escalated to 600mg TID and finally 800mg TID as indicated
- Measurement of blood pressure every four hours after administration until patient discharge
- Measurement of urine output every 12 hours until discharge
- Compare average systolic, diastolic and mean arterial pressures between the two groups during admission and at one week postpartum
- Data will be collected using the OB Staff population at Miami Valley Hospital Main Campus.
- The research will be analyzed and interpreted by the research team conducting the study.
- Potential difficulties and limitations include compliance concerns of mandatory one week blood pressure follow up appointment.
- Using the Veena et al paper as a frame of reference, a sample size of 140 divided evenly across the two treatment arms would achieve statistical significance in determining the need to escalate anti-hypertensive therapy.
- The unit cost of one tablet of labetalol 200mg and furosemide 20mg is currently $0.32 and $1.23, respectively. 8,9
- The study would use already readily available automated blood pressure cuff machines on the postpartum wing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| labetalol + furosemide | Experimental | Drug: furosemide, Drug: labetalollabetalol + furosemide |
| labetalol only | Active comparator | Drug: labetalollabetalol only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Postpartum women delivering at Miami Valley Hospital
- Diagnosis of gestational hypertension or preeclampsia
- Able to provide written informed consent
Key exclusion criteria (3 listed)
- Diagnosis of chronic hypertension
- Allergy to study medications
- Unable to understand English
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 |
|---|---|---|
| furosemideAlso: lasixfive day course of furosemide 20mg QD | Drug | labetalol + furosemide |
| labetalolAlso: trandate200mg labetalol BID | Drug | labetalol + furosemide, labetalol only |
Primary outcome
Change of Dose for Antihypertensive Therapy
Time frame: Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)
number of patients who require a change in the dose of labetalol to control BP
6 secondary outcomes
Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)
Time frame: Average systolic blood pressure for Day 0, Day 1, and Day 2
Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)
Time frame: Average mean arterial pressure on Day 0, Day 1, and Day 2
Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)
Time frame: Average diastolic blood pressure on Day 0, Day 1, and Day 2
Hospital Length of Stay
Time frame: Number of days of hospital stay from randomization to discharge
Breastfeeding Status
Time frame: at 1 week postpartum visit
Hospital Readmission
Time frame: up to 14 days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27835048Veena P, Perivela L, Raghavan SS. Furosemide in postpartum management of severe preeclampsia: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):84-89. doi: 10.1080/10641955.2016.1239735. Epub 2016 Nov 11.
- Background: PubMed 15511760Matthews G, Gornall R, Saunders NJ. A randomised placebo controlled trial of loop diuretics in moderate/severe pre-eclampsia, following delivery. J Obstet Gynaecol. 1997 Jan;17(1):30-2. doi: 10.1080/01443619750114040.
- Background: PubMed 15625138Ascarelli MH, Johnson V, McCreary H, Cushman J, May WL, Martin JN Jr. Postpartum preeclampsia management with furosemide: a randomized clinical trial. Obstet Gynecol. 2005 Jan;105(1):29-33. doi: 10.1097/01.AOG.0000148270.53433.66.
- Background: PubMed 29187414Cairns AE, Pealing L, Duffy JMN, Roberts N, Tucker KL, Leeson P, MacKillop LH, McManus RJ. Postpartum management of hypertensive disorders of pregnancy: a systematic review. BMJ Open. 2017 Nov 28;7(11):e018696. doi: 10.1136/bmjopen-2017-018696.
- Background: PubMed 22617589Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Iams JD, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012 Jun;119(6):1234-42. doi: 10.1097/AOG.0b013e3182571669.
- Background: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Individual participant dataSharing planned: No. Data will be shared on a case by case basis
Related trials for Hypertension, Pregnancy-Induced
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
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.
Sheela Barhan, MD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing furosemide and labetalol in people with Hypertension, Pregnancy-Induced, run by Wright State University 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Oct 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Oct 2023). 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?
Change of Dose for Antihypertensive Therapy (time frame: Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)). 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 NCT04343235, which also lists 6 linked publications.
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 23 Oct 2023.