Chronic Hypertension Complicating Pregnancy (Diagnosis)Early Phase 1NCT03245970
Impedance Cardiography to Decrease the Risk of Preeclampsia
A Early Phase 1 study testing Labetalol Hydrocholoride 200 mg orally every 12 hours, Nifedipine 60 mg orally daily and Atenolol 25 mg daily in people with Chronic Hypertension Complicating Pregnancy (Diagnosis) and Preeclampsia, run by University of Tennessee Medical Center at 1 site in United States.
Trial summary
To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Chronic Hypertension Complicating Pregnancy (Diagnosis), Preeclampsia
- What is being tested?
- Labetalol Hydrocholoride 200 mg orally every 12 hours, Nifedipine 60 mg orally daily and Atenolol 25 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 29 Feb 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic hypertension - Not on antihypertensive medications
Who cannot join
- Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy Patients who have a blood pressure 140/90 or greater -
Trial locations and contacts
1 site in 1 country.
United States1 site
HIgh Risk Obstetrical Consultants
Knoxville, Tennessee, 37920
About this study
Official title: Use of Impedance Cardiography to Decrease the Risk of Preeclampsia
To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.
Read the detailed description
Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output is occurring. The test is easy to perform and non invasive. The treatment for an elevated cardiac output in pregnancy is a beta-blocker while a vasodilator is used for vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make the cardiovascular parameters worse, leading to no improvement in future pregnancy issues. Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it could potentially make the cardiovascular parameters worse.
All centers in the United States that choose to prescribe an antihypertensive medication for use in pregnancy do so by trial and error, whereas impedance cardiography can help the clinician choose the best medication from the start. Many pregnant patient patients have chronic hypertension and this population is at increased risk for superimposed preeclampsia and other pregnancy complications. The current recommendation for pregnancy is to NOT treat mild hypertension because studies have not shown any benefit. These studies, have also not shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not improving the rate of superimposed preeclampsia and other pregnancy related complications.
- Being tested
- Labetalol Hydrocholoride 200 mg orally every 12 hours, Nifedipine 60 mg orally daily, Atenolol 25 mg daily
- Medical subject headings
- Disease, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labetalol Hydrocholoride 200 mg orally every 12 hoursDrug
Also called Trandate
Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography
Nifedipine 60 mg orally dailyDrug
Also called Procardia
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
Atenolol 25 mg dailyDrug
Also called Tenormin
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Treatment arm patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.
Intervention: Labetalol Hydrocholoride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily Receives: Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours; Drug: Nifedipine 60 mg orally daily; Drug: Atenolol 25 mg daily |
| Non Treatment | No intervention | Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of preeclampsia in chronically hypertensive pregnant women
Rates of preeclampsia in chronically hypertensive pregnant women
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start24 Apr 2017
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Why it stopped: Investigator retired. Other investigators did not want to continue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hypertension Complicating Pregnancy (Diagnosis)Studies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to treatment or non treatment group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Fortner, MD, Principal investigator, University of Tennessee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245970
- Sponsor's protocol ID
- 4222
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2017
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Impedance Cardiography to Decrease the Risk of Preeclampsia
- ClinicalTrials.gov ID
- NCT03245970
- Acronym / sponsor ID
- 4222
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator retired. Other investigators did not want to continue study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Tennessee Medical CenterUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.
Detailed description
Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output is occurring. The test is easy to perform and non invasive. The treatment for an elevated cardiac output in pregnancy is a beta-blocker while a vasodilator is used for vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make the cardiovascular parameters worse, leading to no improvement in future pregnancy issues. Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it could potentially make the cardiovascular parameters worse.
All centers in the United States that choose to prescribe an antihypertensive medication for use in pregnancy do so by trial and error, whereas impedance cardiography can help the clinician choose the best medication from the start. Many pregnant patient patients have chronic hypertension and this population is at increased risk for superimposed preeclampsia and other pregnancy complications. The current recommendation for pregnancy is to NOT treat mild hypertension because studies have not shown any benefit. These studies, have also not shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not improving the rate of superimposed preeclampsia and other pregnancy related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to treatment or non treatment group
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours, Drug: Nifedipine 60 mg orally daily, Drug: Atenolol 25 mg dailyTreatment arm patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years. Intervention: Labetalol Hydrocholoride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily |
| Non Treatment | No intervention | –Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic hypertension - Not on antihypertensive medications
Key exclusion criteria (1 listed)
- Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy Patients who have a blood pressure 140/90 or greater -
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 |
|---|---|---|
| Labetalol Hydrocholoride 200 mg orally every 12 hoursAlso: TrandateAnti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography | Drug | Treatment Arm |
| Nifedipine 60 mg orally dailyAlso: ProcardiaAnti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography | Drug | Treatment Arm |
| Atenolol 25 mg dailyAlso: TenorminAnti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater | Drug | Treatment Arm |
Primary outcome
Rates of preeclampsia in chronically hypertensive pregnant women
Time frame: 2 years
Rates of preeclampsia in chronically hypertensive pregnant women
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Kimberly Fortner, MD principal investigator
University of Tennessee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Labetalol Hydrocholoride 200 mg orally every 12 hours, Nifedipine 60 mg orally daily and Atenolol 25 mg daily in people with Chronic Hypertension Complicating Pregnancy (Diagnosis) and Preeclampsia, run by University of Tennessee Medical Center 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Aug 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rates of preeclampsia in chronically hypertensive pregnant women (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2020.