Acute Control of Chronic Hypertension

NCT03877692 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 5253
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's history of preexisting hypertension, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.

Conditions

Preeclampsia With Severe Features; Chronic Hypertension in Obstetric Context

Keywords

Hypertension; Labetalol

Outcome Measures

Primary Outcomes (2)

• Time to blood pressure control

  length of time in minutes between IV labetalol treatment and non-severe blood pressure

  This outcome will be measured during antepartum admission and will start with the first dose of IV labetalol given for severe blood pressure until subsequent blood pressure check is non-severe (<160 systolic and <110 diastolic), ending with delivery

• Length of blood pressure control

  length of time in minutes between successful treatment resulting in non-severe blood pressure and need for next dose of IV labetalol

  This outcome will be measured during antepartum admission and will start with the first non-severe blood pressure after IV labetalol dosing until the next dose of IV labetalol is indicated (by severe blood pressure), ending with delivery

Secondary Outcomes (2)

• Maternal adverse events

  within 3 months of delivery

• Neonatal adverse events

  within 28 days of delivery

Study Arms (2)

Experimental labetalol dose

EXPERIMENTAL

Subjects receive 40mg, 60mg, 80mg after each severe BP

Drug: Experimental dosing of labetalol

Current standard of care

ACTIVE COMPARATOR

Subjects receive 20mg, 40mg, 60mg after each severe BP

Other: Standard dosing of labetalol

Interventions

Experimental dosing of labetalol DRUG

Subjects with preexisting hypertension who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the experimental dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.

Experimental labetalol dose

Standard dosing of labetalol OTHER

Subjects with preexisting hypertension who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive either the standard of care dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.

Current standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Gestational age ≥ 24 weeks
• Singleton gestation
• Chronic hypertension as defined as two elevated blood pressures (SBP ≥ 140mmHg and/or DBP ≥ 90mmHg) at least 4 hours apart before 20 weeks gestation

You may not qualify if:

• Known allergic reaction to labetalol
• Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
• Obstructive airway disease
• Bradycardia \< 70 beats/min
• Heart block \> 1st degree or history of heart failure

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center Obstetrics and Gynecology

Albany, New York, 12208, United States

Location

Related Publications (1)

• Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-525. doi: 10.1097/01.AOG.0000460762.59152.d7.

  PMID: 25611642 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principle investigator and outcomes assessor are masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 18, 2019
• Study Start: February 18, 2019
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)