Clinical trial NCT04676295: Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Official title: Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Cardiovascular Diseases
Cardiovascular Risk Factor
Gestational Hypertension
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2020-12-21
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: PE (pre-eclampsia) is a common pregnancy-specific vascular hypertensive disease affecting 3-5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their offspring long-term. PE provides a unique window for early risk profiling and CVD prevention. However, the efficacy of a family oriented lifestyle intervention to lower CVD risk in families with history of PE has not previously been evaluated.

Aim: This study will explore the impact of PE on CVD progression 8-12 years from delivery in mothers and their children, and assess whether a lifestyle intervention is useful for lowering mother and child blood pressure and improving the CVD risk profile overall in families with a history of PE.

Hypothesis: PE is related with CVD progression mediated by elevated blood pressure. Blood pressure and the CVD risk profile overall is modifiable in mothers and children by a 12-month behavioral lifestyle intervention in families with a history of PE.

Study design: Randomized controlled behavioral lifestyle intervention trial where families (mother, child and father from the FINNPEC study) are offered the opportunity to participate in a lifestyle intervention program 8-12 years after a PE pregnancy. 300 PE families will be randomized 1:1 to a 12-month lifestyle intervention program or to a control group. A parallel group of 100 non-PE control families will be assessed at baseline and follow-up.

Main outcome: 24 hour mean blood pressure change between baseline and follow-up in mother and child.

Significance: This study will provide information on CVD progression in mothers and children 8-12 years from a PE pregnancy. Furthermore, the study assess the effect of a 12-month lifestyle intervention on blood pressure and CVD risk profile overall following a PE pregnancy. Potentially, the study provides the opportunity to identify PE families at highest risk of CVD progression and families amenable to blood pressure and CVD risk profile improvement.

Detailed description: Power analysis:

Power calculations were performed in order to detect 5.5 mmHg reduction in maternal systolic blood pressure with a power of 80% and a 2-sided p-value of 0.05 for the difference between the groups (intervention and control PE) (NICE 2011). Accounting for a 20% loss to follow-up or missing data, a sample of 148 women in the PE intervention group and 148 women in the PE control group is needed.

Specific objectives:

1. To assess cardiovascular health and CVD progression in families (mother, child and father) 8-12 years following a PE pregnancy compared with non-PE control families.
2. To assess the effectiveness of a behavioral 12-month lifestyle intervention in mothers and their children 8-12 years following a PE pregnancy to lower blood pressure and improve their CVD risk profile overall.
3. To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.

Eligibility criteria: Inclusion Criteria:

Families are recruited from the FINNPEC cohort. In FINNPEC, PE was defined as hypertension and proteinuria occurring after 20 weeks gestation (American College of Obstetricians and Gynecologists 2002 criteria). Hypertension was defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg. Proteinuria was defined as urinary excretion of ≥0.3 g protein in a 24-hour specimen, or 0.3 g/L, or two ≥1+ readings on a dipstick in a random urine determination with no evidence of a urinary tract infection. Each PE diagnosis was ascertained based on hospital records and confirmed independently by a research nurse and a study physician in the original FINNPEC case-control study including 1450 nulliparous or multiparous women with a singleton pregnancy with PE and 1065 pregnant control women without PE (aged 18-47 years) from all 5 university hospitals in Finland during 2008-2011.

Exclusion criteria in the FINNPEC: multiple pregnancy, inability to speak Finnish or Swedish.

Exclusion Criteria in the FINNCARE:

* Pregnancy and/or lactation (for all mothers)
* Pre-eclampsia in any previous or subsequent pregnancies (for all non-PE mothers)

Primary outcomes:
measure: Blood pressure (mothers)
timeFrame: baseline -12 months
measure: Blood pressure (children)
timeFrame: baseline -12 months
Secondary outcomes:
measure: Blood pressure 24 hour variability (mothers)
timeFrame: baseline -12 months
measure: Arterial stiffness (mothers)
timeFrame: baseline -12 months
measure: Adiposity (mothers)
timeFrame: baseline -12 months
measure: Adiposity (mothers)
timeFrame: baseline -12 months
measure: Adiposity (mothers)
timeFrame: baseline -12 months
measure: Dietary intake (mothers)
timeFrame: baseline -12 months
measure: Dietary intake (mothers)
timeFrame: baseline -12 months
measure: Dietary intake (mothers)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (mothers)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (mothers)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (mothers)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (mothers)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (mothers)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (mothers)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (mothers)
timeFrame: baseline -12 months
measure: Smoking (mothers)
timeFrame: baseline -12 months
measure: Laboratory assessment of cardiovascular risk (mothers)
timeFrame: baseline -12 months
measure: Laboratory assessment of cardiovascular risk (mothers)
timeFrame: baseline -12 months
measure: Laboratory assessment of cardiovascular risk (mothers)
timeFrame: baseline -12 months
measure: Awareness of later life morbidity (mothers)
timeFrame: baseline -12 months
measure: Heart rate variability (mothers)
timeFrame: baseline -12 months
measure: Blood pressure 24 hour variability (children)
timeFrame: baseline -12 months
measure: Arterial stiffness (children)
timeFrame: baseline -12 months
measure: Adiposity (children)
timeFrame: baseline -12 months
measure: Adiposity (children)
timeFrame: baseline -12 months
measure: Adiposity (children)
timeFrame: baseline -12 months
measure: Dietary intake (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Physical activity and sedentary behavior (children)
timeFrame: baseline -12 months
measure: Laboratory assessment of cardiovascular risk (children)
timeFrame: baseline -12 months
measure: Laboratory assessment of cardiovascular risk (children)
timeFrame: baseline -12 months
measure: Laboratory assessment of cardiovascular risk (children)
timeFrame: baseline -12 months
measure: Process evaluation: reach
timeFrame: baseline
measure: Process evaluation: reach
timeFrame: baseline
measure: Process evaluation: compliance
timeFrame: baseline -12 months
measure: Process evaluation: compliance
timeFrame: baseline -12 months
measure: Process evaluation: acceptability
timeFrame: baseline -12 months
measure: Process evaluation: acceptability
timeFrame: baseline -12 months
measure: Process evaluation: acceptability
timeFrame: baseline -12 months
Other outcomes:
measure: Arterial wall thickness (mothers)
timeFrame: baseline
measure: Left ventricular mass (mothers)
timeFrame: baseline
measure: Left ventricular systolic function (mothers)
timeFrame: baseline
measure: Left ventricular diastolic function (mothers)
timeFrame: baseline
measure: Left ventricular diastolic function (mothers)
timeFrame: baseline
measure: Left ventricular diastolic function (mothers)
timeFrame: baseline
measure: Left ventricular diastolic function (mothers)
timeFrame: baseline
measure: Arterial wall thickness (children)
timeFrame: baseline
measure: Left ventricular mass (children)
timeFrame: baseline
measure: Left ventricular systolic function (children)
timeFrame: baseline
measure: Left ventricular diastolic function (children)
timeFrame: baseline
measure: Left ventricular diastolic function (children)
timeFrame: baseline
measure: Left ventricular diastolic function (children)
timeFrame: baseline
measure: Left ventricular diastolic function (children)
timeFrame: baseline
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: University of Helsinki
name: Tiina Jääskeläinen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki and University of Tampere
name: Hannele Laivuori, Prof, MD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Taisto Sarkola, PhD, MD
role: STUDY_DIRECTOR
References:
citation: Jaaskelainen T, Heinonen S, Kajantie E, Kere J, Kivinen K, Pouta A, Laivuori H; FINNPEC Study Group. Cohort profile: the Finnish Genetics of Pre-eclampsia Consortium (FINNPEC). BMJ Open. 2016 Nov 10;6(11):e013148. doi: 10.1136/bmjopen-2016-013148.