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Chronic Hypertension and Pregnancy (CHAP) Project

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Anti-hypertensive therapy (Other); No to low dose anti-hypertensive therapy (Other)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Alan Tita, MD, PhD, Principal Investigator, Affiliation: University of Alabama at Birmingham - Clinical Coordinating Center
Gary Cutter, PhD, Principal Investigator, Affiliation: University of Alabama at Birmingham-Data Coordinating Center

Overall contact:
Alan Tita, MD, PhD, Phone: 205-934-5612, Email: atita@uabmc.edu

Summary

The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant adults (<140/90 mmHg) compared to usual care (no treatment unless BP is severe) is effective and safe.

Clinical Details

Official title: A Pragmatic Multicenter RCT of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Composite adverse perinatal outcome

Small for Gestational Age

Secondary outcome:

Composite of maternal death or severe cardiovascular morbidity

Composite of severe adverse perinatal outcome

Adherence to treatment after delivery

Detailed description: During pregnancy, chronic hypertension (CHTN) is the most common major medical disorder encountered, occurring in 2-6%. The substantial negative effect of CHTN on pregnancy includes a consistent 3- to 5-fold increase in superimposed preeclampsia and adverse

perinatal outcomes (fetal or neonatal death, preterm birth - PTB, poor fetal growth and

placental abruption) and possibly a 5- to10-fold increase in maternal cardiovascular and other complications (death, cerebrovascular accident, pulmonary edema and acute renal failure). Mild CHTN (BP <160/110) contributes to a large proportion of these adverse outcomes. While antihypertensive treatment of CHTN is standard for the general population, it is uncertain whether treatment during pregnancy reduces maternal or fetal complications, and there are concerns that decreased arterial pressure may reduce fetal blood flow and cause poor fetal growth or small-for-gestational-age (SGA) infants. Some authorities, including the American College of Obstetricians and Gynecologists (ACOG) and American Society of Hypertension (ASH) recommend against starting or continuing antihypertensive therapy for mild CHTN, particularly if BP is <160/105-110 mmHg. The recommendation to withhold antihypertensive treatment in pregnancy conflicts with the broader public health goal to reduce BP in those with CHTN and there is no evidence that discontinuing therapy during the brief period of pregnancy affects outcomes. For over a decade, authorities have consistently called for well-designed and powered trials to delineate the benefits and risks of pharmacologic therapy for CHTN during pregnancy. Therefore, our multicenter consortium proposes the Chronic Hypertension and Pregnancy (CHAP) Project, a large pragmatic randomized trial with a primary aim to evaluate the benefits and harms of pharmacologic treatment of mild CHTN in pregnancy.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-154 systolic or 90-99 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤150/95 (including those with blood pressure <140/90); 2. Singleton; and 3. viable pregnancy <18 weeks of gestation. Exclusion Criteria: 1. Blood pressures prior to randomization ≥155 systolic or ≥100 diastolic (with or without treatment); 2. Patients currently treated with >1 antihypertensive medication (more like to have severe chronic hypertension); 3. Multi-fetal pregnancy; 4. Known secondary cause of chronic hypertension; 5. High-risk co-morbidities for which treatment may be indicated:

- Class C or higher diabetes mellitus

- Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, p/c ratio

>0. 3, or persistent 1+ proteinuria*) or creatinine >1. 2. *If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine <300mg/24hr or p/c ratio is <0. 3.

- Cardiac disorders: cardiomyopathy, angina, CAD

- Prior stroke

- Retinopathy

- Sickle cell disease;

6. Known major fetal anomaly; 7. Known fetal demise; 8. Suspected IUGR; 9. Membrane rupture or planned termination prior to randomization; 10. Plan to deliver outside the consortium centers or unlikely to follow-up in the opinion of study staff or previous participation in this trial; 11. Contraindication to labetalol or nifedipine (e. g. know hypersensitivity); and (12) Current substance abuse or addiction (cocaine, methamphetamine) *The minimum age varies by center

Locations and Contacts

Alan Tita, MD, PhD, Phone: 205-934-5612, Email: atita@uabmc.edu

University of Alabama at Birmingham, Clinical Coordinating Center, Birmingham, Alabama 35294, United States; Not yet recruiting
Alan T Tita, MD, PhD, Email: atita@uabmc.edu
Alan Tita, MD, PhD, Principal Investigator

University of Alabama at Birmingham, Data Coordinating Center, Birmingham, Alabama 35294, United States; Active, not recruiting

University of California San Francisco, San Francisco, California 94143, United States; Not yet recruiting
Mary Norton, MD, Phone: 415-353-7865, Email: nortonm@obgyn.ucsf.edu
Mary Norton, MD, Principal Investigator

Stanford University, Stanford, California 94305, United States; Not yet recruiting
Yasser El-Sayed, MD, Phone: 650-723-3198, Email: elsayed@stanford.edu
Yasser El-Sayed, MD, Principal Investigator

Christiana Care Health Services, Newark, Delaware 19713, United States; Not yet recruiting
Matthew Hoffman, MD, MPH
Matthew Hoffman, MD, MPH, Principal Investigator
Richard Derman, MD, MPH, Principal Investigator

Ochsner Health System/Medical Center, New Orleans, Louisiana 70115, United States; Not yet recruiting
Sherri Longo, MD, Phone: 504-842-4151, Email: slongo@ochsner.org
Sherri Longo, MD, Principal Investigator

Johns Hopkins Universty, Baltimore, Maryland 21287, United States; Not yet recruiting
Irina Burd, MD, PhD
Irina Burd, MD, PhD, Principal Investigator

Washington University, St Louis, Missouri 63110, United States; Not yet recruiting
George A Macones, MD, MSCE, Phone: 314-362-7139, Email: Maconesg@wudosis.wustl.edu
George Macones, MD, MSCE, Principal Investigator
Methodius Tuuli, MD, MPH, Principal Investigator

Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901, United States; Not yet recruiting
Todd Rosen, MD
Todd Rosen, MD, Principal Investigator

St. Peters University Hospital, New Brunswick, New Jersey 08901, United States; Not yet recruiting
A. Liam Ness, MD, MSCP
A. Liam Ness, MD, MSCP, Principal Investigator

Columbia University, New York, New York 10032, United States; Not yet recruiting
Kirsten Cleary, MD, Phone: 212-305-1527, Email: klc2108@cumc.columbia.edu
Kirsten Cleary, MD, Principal Investigator
Ron Wapner, MD, Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27599, United States; Not yet recruiting
Kim Boggess, MD, Phone: 919-966-1601, Email: Kim.boggess@med.unc.edu
Kim Boggess, MD, Principal Investigator

Duke University, Durham, North Carolina 27705, United States; Not yet recruiting
Amy Murtha, MD, Phone: 919-684-3225, Email: amy.murtha@duke.edu
Amy Murtha, MD, Principal Investigator
Geeta Swamy, MD, Sub-Investigator

Lehigh Valley Hospital/Health Network, Allentown, Pennsylvania 18101, United States

Drexel University College of Medicine, Philadelphia, Pennsylvania 19019, United States; Not yet recruiting
Lauren Plante, MD, MPH
Lauren Plante, MD, MPH, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Not yet recruiting
Lorraine Dugoff, MD, Phone: 215-615-3739, Email: Lorraine.Dugoff@uphs.upenn.edu
Lorraine Dugoff, MD, Principal Investigator

University of Pittsburg, Pittsburg, Pennsylvania 15201, United States; Not yet recruiting
Hyagriv Simhan, MD, MS, Phone: 412-641-4874, Email: hsimhan@mail.magee.edu
Hyagriv Simhan, MD, Principal Investigator

UT Southwestern, Dallas, Texas 75390, United States; Not yet recruiting
Brian Casey, MD, Phone: 214-648-4746, Email: Brian.casey@utsouthwestern.edu
Brian Casey, MD, Principal Investigator

UT Medical Branch, Galveston, Texas 77555, United States; Not yet recruiting
George R Saade, MD, Phone: 409-747-0482, Email: gsaade@utmb.edu
George Saade, MD, Principal Investigator

UT Houston, Houston, Texas 77030, United States; Not yet recruiting
Sean Blackwell, MD, Phone: 713-500-7780, Email: Sean.Blackwell@uth.tmc.edu
Sean Blackwell, MD, Principal Investigator
Baha Sibai, MD, Principal Investigator

Intermountain Healthcare, Salt Lake City, Utah 84132, United States; Not yet recruiting
Michael Varner, MD, Email: Michael.Varner@hsc.utah.edu
Michael Varner, MD, Principal Investigator

University of Utah, Salt Lake City, Utah 84132, United States; Not yet recruiting
Michael Varner, MD, Email: Michael.Varner@hsc.utah.edu
Michael Varner, MD, Principal Investigator

Additional Information

Starting date: August 2015
Last updated: May 25, 2015

Page last updated: August 23, 2015

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