Pregnancy as a Window to the Future: Outcomes of Antihypertensive Therapy and Superimposed Preeclampsia in Pregnant Women with Mild Chronic Hypertension (CHAP Maternal Follow-up Study)
怀孕是通向未来的窗口:轻度慢性高血压孕妇的抗高血压治疗和叠加先兆子痫的结果(CHAP 产妇随访研究)
基本信息
- 批准号:10463767
- 负责人:
- 金额:$ 210.32万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-09-01 至 2026-08-31
- 项目状态:未结题
- 来源:
- 关键词:AddressAffectAgeAmerican College of Obstetricians and GynecologistsAntihypertensive AgentsAtherosclerosisBiologicalBiological MarkersBirth WeightBloodBlood PressureCardiovascular DiseasesCardiovascular systemCessation of lifeChildChronicCoronary heart diseaseCountryDataDevelopmentDiabetes MellitusDiscipline of obstetricsDiseaseDisease OutcomeEarly treatmentEnrollmentEthnic OriginFetal Growth RetardationFollow-Up StudiesFrequenciesFutureGeneral PopulationGoalsHealthHeart failureHypertensionInternationalKidney FailureKnowledgeLipidsLong-Term EffectsMaternal HealthMedicalMedical RecordsMorbidity - disease rateMyocardial InfarctionNational Heart, Lung, and Blood InstituteNational Institute of Child Health and Human DevelopmentNeonatal MortalityNewborn InfantNon-Insulin-Dependent Diabetes MellitusOutcomeOutcome StudyParticipantPerinatalPersonsPharmacological TreatmentPopulationPostpartum PeriodPre-EclampsiaPregnancyPregnant WomenPremature BirthPrevention strategyProfessional OrganizationsQuestionnairesRaceRandomizedRecommendationRecording of previous eventsReproductive HealthRiskRisk FactorsRoleSafetySiteSmall for Gestational Age InfantSmoking StatusSpecimenStrokeTestingTimeUncertaintyUrineVisitWomanadjudicateadverse outcomeagedcardiovascular disorder riskcognitive functioncohortdesignfetalfollow-upimprovedindexingmaternal riskoffspringoptimal treatmentsprepregnancyprimary outcomeprospectiveremote gradingreproductivetoolvenous thromboembolism
项目摘要
PROJECT SUMMARY/ABSTRACT
The large randomized multicenter Chronic Hypertension and Pregnancy (CHAP) trial (2015-2021) was
designed to evaluate the short-term benefits and safety of pharmacologic treatment of pregnant women with
mild chronic hypertension (CHTN). This proposed CHAP Maternal Follow-Up project (2021-2026) is a follow-up
study of the well-characterized women in CHAP to address the critical knowledge gaps regarding whether
future long-term cardiovascular disease (CVD) and other outcomes are associated with 1) antihypertensive
therapy use early in pregnancy and 2) the development of superimposed preeclampsia (SI PRE). CHTN is the
most common major medical disorder seen in pregnancy, is most often mild (i.e. BP <160/110 mmHg), and
associated with adverse outcomes, including preeclampsia, death, preterm birth and small for gestational age
(SGA) infants (birth weight <10th percentile). Whereas antihypertensive therapy is a priority for the general
population, the American College of Obstetricians and Gynecologists (ACOG), recommends withholding
antihypertensive therapy during pregnancy unless CHTN is severe (BP≥160/110 mm Hg) due to uncertain
benefits and concern that therapy may increase the risk of SGA infants. An international controversy regarding
optimal treatment during pregnancy will be informed by these data on long-term outcomes. Whereas
preeclampsia in women without CHTN increases their future risk of CHTN and CVD, the long-term effects of SI
PRE and antihypertensive therapy in women with preexisting CHTN are uncertain. During this proposed 5-
year project, our consortium of up to 60 sites, will follow-up the CHAP participants every 6 months (in-person
or remotely, review medical records and administer questionnaires) to obtain interval history, serial BPs and
outcome data, and collect bio-specimens. We anticipate 1804 (75%) of the 2404 in CHAP will be studied to
address the following Specific Aims:
Specific Aim 1: Test the hypothesis that antihypertensive therapy for mild CHTN during pregnancy to achieve
a BP goal <140/90 compared with no treatment reduces the frequency of maternal CVD outcomes 5 to 10
years postpartum, including the primary composite of severe CHTN (a marker of future CVD), heart failure,
stroke, myocardial infarction/angina, renal failure, venous thromboembolism (VTE) or death.
Specific Aim 2: Test the hypothesis that the development of SI PRE in pregnant women with mild CHTN
increases the risk of maternal CVD outcomes 5 to 10 years postpartum, including the primary composite of
severe CHTN, heart failure, stroke, myocardial infarction/angina, renal failure, VTE and death.
Specific Aim 3 (Exploratory): Test whether available components of the ACC/AHA ASCVD risk score (age,
race-ethnicity, diabetes mellitus, smoking status, baseline BP, pre-pregnancy treatment) and pregnancy data
(treatment and SI PRE) in women with mild CHTN predict maternal CVD outcomes 5-10 years postpartum. We
will also collect and store maternal blood and urine for future biomarker and biological studies.
项目概要/摘要
大型随机多中心慢性高血压与妊娠 (CHAP) 试验(2015-2021 年)
旨在评估妊娠妇女药物治疗的短期益处和安全性
轻度慢性高血压(CHTN)。本提议的 CHAP 产妇随访项目(2021-2026 年)是后续项目
对 CHAP 中具有良好特征的女性进行研究,以解决关于是否
未来的长期心血管疾病 (CVD) 和其他结果与 1) 抗高血压药物相关
妊娠早期使用治疗以及 2) 叠加先兆子痫 (SI PRE) 的发展。 CHTN 是
怀孕期间最常见的主要疾病,通常是轻微的(即血压<160/110 mmHg),并且
与不良后果相关,包括先兆子痫、死亡、早产和小于胎龄
(SGA) 婴儿(出生体重<10%)。而抗高血压治疗是一般人的首要任务
美国妇产科医师学会 (ACOG) 建议扣留人口
妊娠期间的抗高血压治疗,除非由于不确定而导致 CHTN 严重(BP≥160/110 mm Hg)
治疗可能增加 SGA 婴儿风险的益处和担忧。一场国际争议
这些长期结果数据将为怀孕期间的最佳治疗提供依据。然而
没有 CHTN 的女性的先兆子痫会增加她们未来患 CHTN 和 CVD 的风险,SI 的长期影响
对于既往患有 CHTN 的女性,PRE 和抗高血压治疗尚不确定。在此提议的 5-
年项目,我们由多达 60 个站点组成的联盟将每 6 个月对 CHAP 参与者进行一次跟踪(亲自
或远程查看病历并进行问卷调查)以获得间隔病史、连续血压和
结果数据并收集生物样本。我们预计 CHAP 2404 中的 1804 (75%) 将被研究
解决以下具体目标:
具体目标 1:检验孕期轻度 CHTN 抗高血压治疗可达到的假设
与不治疗相比,血压目标 <140/90 可将孕产妇 CVD 结果的频率降低 5 至 10
产后数年,包括严重 CHTN(未来 CVD 的标志)、心力衰竭、
中风、心肌梗死/心绞痛、肾衰竭、静脉血栓栓塞 (VTE) 或死亡。
具体目标 2:检验患有轻度 CHTN 的孕妇发生 SI PRE 的假设
增加产后 5 至 10 年产妇 CVD 结局的风险,包括主要复合因素
严重 CHTN、心力衰竭、中风、心肌梗塞/心绞痛、肾衰竭、静脉血栓栓塞和死亡。
具体目标 3(探索性):测试 ACC/AHA ASCVD 风险评分的可用组成部分(年龄、
种族、糖尿病、吸烟状况、基线血压、孕前治疗)和妊娠数据
(治疗和 SI PRE)对患有轻度 CHTN 的女性可预测产后 5-10 年的母亲 CVD 结局。我们
还将收集和储存母体血液和尿液,用于未来的生物标志物和生物学研究。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Suzanne Oparil其他文献
Suzanne Oparil的其他文献
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{{ truncateString('Suzanne Oparil', 18)}}的其他基金
30th Annual Vascular Biology and Hypertension Symposium
第30届年度血管生物学和高血压研讨会
- 批准号:
9761808 - 财政年份:2019
- 资助金额:
$ 210.32万 - 项目类别:
Pregnancy as a Window to the Future: Outcomes of Antihypertensive Therapy and Superimposed Preeclampsia in Pregnant Women with Mild Chronic Hypertension (CHAP Maternal Follow-up Study)
怀孕是通向未来的窗口:轻度慢性高血压孕妇的抗高血压治疗和叠加先兆子痫的结果(CHAP 产妇随访研究)
- 批准号:
10316567 - 财政年份:2014
- 资助金额:
$ 210.32万 - 项目类别:
Pregnancy as a Window to the Future: Outcomes of Antihypertensive Therapy and Superimposed Preeclampsia in Pregnant Women with Mild Chronic Hypertension (CHAP Maternal Follow-up Study)
怀孕是通向未来的窗口:轻度慢性高血压孕妇的抗高血压治疗和叠加先兆子痫的结果(CHAP 产妇随访研究)
- 批准号:
10685259 - 财政年份:2014
- 资助金额:
$ 210.32万 - 项目类别:
O-GlyNAcylation: Novel Mechanism of Estrogen-Induced Vasoprotection
O-甘氨酰化:雌激素诱导血管保护的新机制
- 批准号:
8204767 - 财政年份:2009
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$ 210.32万 - 项目类别:
O-GlyNAcylation: Novel Mechanism of Estrogen-Induced Vasoprotection
O-甘氨酰化:雌激素诱导血管保护的新机制
- 批准号:
7751306 - 财政年份:2009
- 资助金额:
$ 210.32万 - 项目类别:
O-GlyNAcylation: Novel Mechanism of Estrogen-Induced Vasoprotection
O-甘氨酰化:雌激素诱导血管保护的新机制
- 批准号:
7580121 - 财政年份:2009
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