Trial record 1 of 1 for:
02299414
Chronic Hypertension and Pregnancy (CHAP) Project (CHAP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02299414 |
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Recruitment Status :
Completed
First Posted : November 24, 2014
Results First Posted : May 17, 2023
Last Update Posted : May 17, 2023
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Sponsor:
University of Alabama at Birmingham
Collaborators:
Columbia University
Drexel University College of Medicine
Rutgers, The State University of New Jersey
Lehigh Valley Hospital
Saint Peters University Hospital
Christiana Care Health Services
Washington University School of Medicine
Duke University
University of Texas Southwestern Medical Center
The University of Texas Health Science Center, Houston
Stanford University
University of Pennsylvania
The University of Texas Medical Branch, Galveston
University of Utah
Intermountain Health Care, Inc.
University of California, San Francisco
Johns Hopkins University
University of Pittsburgh
Ochsner Health System
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
WakeMed Health and Hospitals
San Francisco General Hospital
McKay-Dee Hospital
Winthrop University Hospital
New York Hospital Queens
Latter Day Saints Hospital
Lyndon B Johnson General Hospital
Virtua Medical Group
Bayview Medical Center
Duke Regional Hospital
Utah Valley Regional Medical Center
Northwestern
Brown (WIHRI)
Baylor College of Medicine
Case Western/Metro Health
Ohio State University
University of Iowa
University of California, San Diego
Indiana University
Unity Point Health-Meriter Hospital WI
Weill Medical College of Cornell University
University of Oklahoma
Medical University of South Carolina
Beaumont Hospital
University of Colorado, Denver
University of Kansas Medical Center
Denver Health and Hospital Authority
Gundersen Health System
Aurora Health Care
Oregon Health and Science University
Medical College of Wisconsin
Temple University
New Jersey Medical School
University of South Alabama
Vanderbilt University
University of Arkansas
Emory University
St. Luke's Hospital and Health Network, Pennsylvania
Cleveland Clinic Fairview Hospital
University of Tennessee
TriHealth Inc.
Cleveland Clinic Hillcrest Hospital
Tulane University
Yale University
Arrowhead Regional Medical Center
Geisinger Clinic
Premier Health Miami Valley Hospital
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham
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Brief 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 reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Drug: Anti-hypertensive therapy Other: No anti-hypertensive therapy (unless BP is severe) | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2408 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project |
| Actual Study Start Date : | June 2015 |
| Actual Primary Completion Date : | April 1, 2022 |
| Actual Study Completion Date : | December 16, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
Drug Information available for:
Nifedipine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Anti-hypertensive therapy to goal <140/90 mmHg
Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used
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Drug: Anti-hypertensive therapy
1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
Other Names:
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Active Comparator: No anti-hypertensive unless BP is severe (≥160/105 mmHg
Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used
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Other: No anti-hypertensive therapy (unless BP is severe)
Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105. |
Primary Outcome Measures :
- Composite Adverse Perinatal Outcome [ Time Frame: Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death ]One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB <35 weeks (not due to spontaneous preterm labor or membrane rupture).
- Small for Gestational Age (Safety) [ Time Frame: Until delivery ]Birth weight less than 10th percentile for gestational age at birth according to accepted national standard
Secondary Outcome Measures :
- Composite of Maternal Death or Severe Cardiovascular Morbidity [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]One or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure
- Severe Maternal Hypertension + Components of the Primary Composite Endpoint [ Time Frame: Up to 2 weeks postpartum or 90 days for neonatal death ]Persistent severe hypertension with or without proteinuria + the primary composite
- Preterm Birth and Indicated Preterm Birth (<37 Weeks) [ Time Frame: Until delivery ]Preterm birth and Indicated preterm birth (<37 weeks) includes any preterm birth less than 37 weeks
- Composite of Severe Neonatal Morbidities [ Time Frame: Up to 90 days post delivery ]One or more of Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP), Necrotizing enterocolitis (NEC), Intraventricular hemorrhage (VH) grade III/IV
- Adherence to Treatment After Delivery [ Time Frame: 6 weeks (4-12 weeks) after delivery ]Counts with high adherence to antihypertensive therapy after delivery for those prescribed medications.
Other Outcome Measures:
- Superimposed Preeclampsia [ Time Frame: Up to 2 weeks after delivery ]Mild or severe, including eclampsia
- Superimposed Gestational Hypertension [ Time Frame: Enrollment (between 6 and 18 weeks gestation) to delivery ]Persistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation
- Severe Hypertension [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]Blood pressure ≥160/110
- Cesarean Delivery [ Time Frame: Until delivery ]Cesarean delivery
- Blood Transfusion [ Time Frame: Up to 6 weeks ]During pregnancy or postpartum
- NICU Admission [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]Any NICU admission
- Low Birth Weight [ Time Frame: At birth ]Birth weight <2500g
- Ponderal Index [ Time Frame: At birth ]Mean ponderal index, mass/height^3 at birth
- Head Circumference [ Time Frame: At birth ]Mean head circumference
- Placental Weight [ Time Frame: At delivery ]Mean placental weight
- Hypoglycemia [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Prevalence of hypoglycemia
- Bradycardia [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Prevalence of bradycardia
- Hypotension [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Incidence (%) with hypotension
- Respiratory Distress Syndrome (RDS) [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Incidence (%) with respiratory distress syndrome (RDS)
- Bronchopulmonary Dysplasia (BPD) [ Time Frame: Up to 3 months after delivery ]Incidence (%) with bronchopulmonary dysplasia (BPD)
- Intubation/Ventilation [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Incidence (%) with resuscitation including oxygen, intubation, chest compression/CPR, or CPAP
- Intraventricular Hemorrhage (IVH) [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Incidence (%) with any IVH and with IVH Grades III and IV
- Necrotizing Enterocolitis (NEC) [ Time Frame: Up to 3 months after delivery ]Incidence (%) with necrotizing enterocolitis (NEC)
- Hyperbilirubinemia [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Incidence (%) with hyperbilirubinemia
- 5-min Apgar Score [ Time Frame: At delivery ]Incidence (%) with Apgar score <7 (range 0-10 with lower scores indicating worse outcome)
- Sepsis [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]Incidence (%) with proven sepsis
- Unscheduled Prenatal Clinic or ER Visits [ Time Frame: Up to 3 months after delivery ]Number of unscheduled clinic or ER visits before and after delivery
- Hospitalizations [ Time Frame: Up to 3 months postpartum ]Number of hospitalizations before or after delivery
- Postpartum Unscheduled or ER Visits [ Time Frame: Up to 3 months after delivery ]Number of postpartum unscheduled or ER visits
- Postpartum Hospitalizations [ Time Frame: Up to 3 months after delivery ]Number of postpartum hospitalizations
- Neonatal Hospital Stay of 3 or More Days [ Time Frame: after delivery ]Frequency of neonatal hospital stays lasting at least 3 days
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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);
- Singleton; and
- viable pregnancy <23 weeks of gestation.
Exclusion Criteria:
- Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment);
- Severe hypertension including patients currently treated with >1 antihypertensive medication (more likely to have severe chronic hypertension);
- Multi-fetal pregnancy;
- Known secondary cause of chronic hypertension;
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High-risk co-morbidities for which treatment may be indicated:
- Diabetes mellitus diagnosed at age ≤10 years or duration of diagnosis ≥20 years
- Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant)
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Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, protein/creatinine 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. If a p/c ratio is >0.3, the patient may be included if a 24-hour urine is < 300 mg.
- Cardiac disorders: cardiomyopathy, angina, CAD
- Prior stroke
- Retinopathy
- Sickle cell disease
- Known major fetal anomaly;
- Known fetal demise;
- Suspected IUGR;
- Membrane rupture or planned termination prior to randomization;
- 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;
- Contraindication to labetalol and nifedipine (e.g. know hypersensitivity);
- Current substance abuse or addiction (cocaine, methamphetamine)
- Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee)
- Physician or provider refusal
- Patient refusal *The minimum age varies by center
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299414
Locations
Show 72 study locations
Sponsors and Collaborators
University of Alabama at Birmingham
Columbia University
Drexel University College of Medicine
Rutgers, The State University of New Jersey
Lehigh Valley Hospital
Saint Peters University Hospital
Christiana Care Health Services
Washington University School of Medicine
Duke University
University of Texas Southwestern Medical Center
The University of Texas Health Science Center, Houston
Stanford University
University of Pennsylvania
The University of Texas Medical Branch, Galveston
University of Utah
Intermountain Health Care, Inc.
University of California, San Francisco
Johns Hopkins University
University of Pittsburgh
Ochsner Health System
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
WakeMed Health and Hospitals
San Francisco General Hospital
McKay-Dee Hospital
Winthrop University Hospital
New York Hospital Queens
Latter Day Saints Hospital
Lyndon B Johnson General Hospital
Virtua Medical Group
Bayview Medical Center
Duke Regional Hospital
Utah Valley Regional Medical Center
Northwestern
Brown (WIHRI)
Baylor College of Medicine
Case Western/Metro Health
Ohio State University
University of Iowa
University of California, San Diego
Indiana University
Unity Point Health-Meriter Hospital WI
Weill Medical College of Cornell University
University of Oklahoma
Medical University of South Carolina
Beaumont Hospital
University of Colorado, Denver
University of Kansas Medical Center
Denver Health and Hospital Authority
Gundersen Health System
Aurora Health Care
Oregon Health and Science University
Medical College of Wisconsin
Temple University
New Jersey Medical School
University of South Alabama
Vanderbilt University
University of Arkansas
Emory University
St. Luke's Hospital and Health Network, Pennsylvania
Cleveland Clinic Fairview Hospital
University of Tennessee
TriHealth Inc.
Cleveland Clinic Hillcrest Hospital
Tulane University
Yale University
Arrowhead Regional Medical Center
Geisinger Clinic
Premier Health Miami Valley Hospital
Investigators
| Principal Investigator: | Alan Tita, MD, PhD | University of Alabama at Birmingham - Clinical Coordinating Center | |
| Principal Investigator: | Gary Cutter, PhD | University of Alabama at Birmingham-Data Coordinating Center | |
| Principal Investigator: | Jeff Szychowski, PhD | University of Alabama at Birmingham-Data Coordinating Center |
Study Documents (Full-Text)
Documents provided by Alan Tita, University of Alabama at Birmingham:
Documents provided by Alan Tita, University of Alabama at Birmingham:
Study Protocol and Statistical Analysis Plan [PDF] December 13, 2021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alan Tita, Principal Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT02299414 |
| Other Study ID Numbers: |
1U01HL119242-01 ( U.S. NIH Grant/Contract ) U01HL119242-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 24, 2014 Key Record Dates |
| Results First Posted: | May 17, 2023 |
| Last Update Posted: | May 17, 2023 |
| Last Verified: | May 2023 |
Keywords provided by Alan Tita, University of Alabama at Birmingham:
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Pregnancy Chronic hypertension |
Additional relevant MeSH terms:
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Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents Nifedipine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Tocolytic Agents Reproductive Control Agents |