Chronic Hypertension and Pregnancy (CHAP) Project



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - Any
Updated:3/16/2019
Start Date:June 2015
End Date:December 2021
Contact:Alan Tita, MD, PhD
Email:atita@uabmc.edu
Phone:205-934-5612

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A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project

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 reproductive-age adults
(<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP
is severe) is effective and safe.

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 withholding 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 maternal
outcomes (other than reducing the severe hypertension). 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.

Inclusion Criteria:

1. Women with chronic hypertension in pregnancy with new or untreated chronic
hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic
hypertension on monotherapy and taking any antihypertensive and blood pressure
≤159/104 (including those with blood pressure <140/90);

2. Singleton; and

3. viable pregnancy <23 weeks of gestation.

Exclusion Criteria:

1. Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or
without treatment);

2. Patients currently treated with >1 antihypertensive medication (more likely 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 (unless approved by the Clinical
Coordinating Center) 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
We found this trial at
72
sites
Sewell, New Jersey 08080
Principal Investigator: Ronald Librizzi, DO
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Irish Krishna, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Brenna Hughes, MD
Phone: 919-684-3225
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Kjersti Aagard, MD
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Everett F. Magann, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Kirsten Cleary, MD
Phone: 212-305-1527
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Lorraine Dugoff, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
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503 494-8311
Principal Investigator: Leonardo Pereira, MD
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Michael Varner, MD
University of Utah Research is a major component in the life of the U benefiting...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Judette Louis, MD
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Allentown, Pennsylvania 18103
Principal Investigator: John Smulian, MD
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Baltimore, Maryland 21224
Principal Investigator: Irina Burd, MD
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Bethlehem, Pennsylvania
Principal Investigator: Joseph Bell, MD
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Birmingham, Alabama 35294
Principal Investigator: Alan Tita, MD, PhD
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Bloomington, Indiana 47405
Principal Investigator: David M Haas, MD
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Boulder, Colorado 80304
Principal Investigator: Emily Su, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Kim Boggess, MD
Phone: 919-966-1601
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Eugene Chang, MD
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Cincinnati, Ohio 45220
Principal Investigator: Mounira Habli, MD
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10900 Euclid Avenue
Cleveland, Ohio 44109
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Cleveland, Ohio 44111
Principal Investigator: Uma Perni, MD
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Heather Frey, MD
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Dallas, Texas 75390
Principal Investigator: Brian Casey, MD
Phone: 214-648-4746
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: David S. McKenna, MD
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Denver, Colorado 80204
Principal Investigator: Nikki Nguyen, MD
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3643 Roxboro St
Durham, North Carolina 27704
Principal Investigator: Brenna Hughes, MD
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633 Clark Street
Evanston, Illinois 60208
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Flushing, New York 11355
Principal Investigator: Daniel Skupski, MD
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Galveston, Texas 77555
Principal Investigator: George Saade, MD
Phone: 409-747-0482
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Houston, Texas 77026
Principal Investigator: Baha Sibai, MD
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Houston, Texas 77030
Phone: 713-500-7780
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2500 North State Street
Jackson, Mississippi 39216
Principal Investigator: Michelle Owens, MD
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1900 South Avenue
La Crosse, Wisconsin 54601
Principal Investigator: Charles Schauberger, MD
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Lawrence, Kansas
Principal Investigator: Marc Parrish, DO
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Madison, Wisconsin 53715
Principal Investigator: Dinesh M Shah, MD
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Marshfield, Wisconsin 54449
Principal Investigator: Kazumasa Hashimoto, MD
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Mayfield Heights, Ohio 44124
Principal Investigator: Uma Perni, MD
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Memphis, Tennessee 38163
Principal Investigator: Giancarlo Mari, MD
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Milwaukee, Wisconsin 53215
Principal Investigator: Ryan Stone, MD
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Anna Palatnik, MD
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Wendy Kinzler, MD
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
Principal Investigator: Susan Baker, MD
University of South Alabama "University of South Alabama is a public institution that was founded...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Sarah Osmundson, MD, MS
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New Brunswick, New Jersey 08901
Principal Investigator: Todd Rosen, MD
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New Brunswick, New Jersey
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Uma Reddy, MD
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New Orleans, Louisiana 70115
Principal Investigator: Sherri Longo, MD
Phone: 504-842-4151
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New Orleans, Louisiana 70112
Principal Investigator: Gabriella Pridjian, MD
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New York, New York 10065
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Newark, Delaware 19713
Principal Investigator: Matthew Hoffman, MD, MPH
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Newark, New Jersey 07107
Principal Investigator: Todd Rosen, MD
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Ogden, Utah
Principal Investigator: Michael Varner, MD
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Principal Investigator: Lauren Plante, MD, MPH
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Lorraine Dugoff, MD
Phone: 215-615-3739
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Wadia Mulla, MD
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Pittsburgh, Pennsylvania 15201
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Phone: 412-641-4874
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Providence, Rhode Island 02912
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Provo, Utah 84604
Principal Investigator: Michael Varner, MD
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Raleigh, North Carolina 27610
Principal Investigator: Kim Boggess, MD
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Royal Oak, Michigan 48073
Principal Investigator: Ali Alhouseinni, MD
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Saint Louis, Missouri 63110
Principal Investigator: George Macones, MD, MSCE
Phone: 314-362-7139
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Salt Lake City, Utah 84143
Principal Investigator: Michael Varner, MD
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8th Ave & C St
Salt Lake City, Utah 84143
(801) 408-1100
Principal Investigator: Michael Varner, MD
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San Diego, California 92093
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San Francisco, California 94110
Principal Investigator: Mary Norton, MD
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San Francisco, California 94143
Principal Investigator: Mary Norton, MD
Phone: 415-353-7865
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Yasser El-Sayed, MD
Phone: 650-723-3198
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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