Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 2:33 PM
Study NCT ID:
NCT04676295
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Arterial wall thickness (mothers)', 'timeFrame': 'baseline', 'description': 'intima-media thickness; common carotid, brachial and radial; mm'}, {'measure': 'Left ventricular mass (mothers)', 'timeFrame': 'baseline', 'description': 'left ventricular mass; g'}, {'measure': 'Left ventricular systolic function (mothers)', 'timeFrame': 'baseline', 'description': 'left ventricular global longitudinal strain; %'}, {'measure': 'Left ventricular diastolic function (mothers)', 'timeFrame': 'baseline', 'description': 'left atrial volume; ml'}, {'measure': 'Left ventricular diastolic function (mothers)', 'timeFrame': 'baseline', 'description': 'pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)'}, {'measure': 'Left ventricular diastolic function (mothers)', 'timeFrame': 'baseline', 'description': 'mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s'}, {'measure': 'Left ventricular diastolic function (mothers)', 'timeFrame': 'baseline', 'description': 'septal pulsed wave tissue Doppler early velocity; cm/s'}, {'measure': 'Arterial wall thickness (children)', 'timeFrame': 'baseline', 'description': 'intima-media thickness; common carotid, brachial and radial; mm'}, {'measure': 'Left ventricular mass (children)', 'timeFrame': 'baseline', 'description': 'left ventricular mass; g'}, {'measure': 'Left ventricular systolic function (children)', 'timeFrame': 'baseline', 'description': 'left ventricular global longitudinal strain; %'}, {'measure': 'Left ventricular diastolic function (children)', 'timeFrame': 'baseline', 'description': 'left atrial volume; ml'}, {'measure': 'Left ventricular diastolic function (children)', 'timeFrame': 'baseline', 'description': 'pulsed wave Doppler mitral early to late inflow velocity ratio (no unit)'}, {'measure': 'Left ventricular diastolic function (children)', 'timeFrame': 'baseline', 'description': 'mitral lateral annular pulsed wave tissue Doppler early velocity; cm/s'}, {'measure': 'Left ventricular diastolic function (children)', 'timeFrame': 'baseline', 'description': 'septal pulsed wave tissue Doppler early velocity; cm/s'}], 'primaryOutcomes': [{'measure': 'Blood pressure (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'mean 24 hour ambulatory systolic BP and diastolic BP; mmHg'}, {'measure': 'Blood pressure (children)', 'timeFrame': 'baseline -12 months', 'description': 'mean 24 hour ambulatory systolic BP and diastolic BP; mmHg'}], 'secondaryOutcomes': [{'measure': 'Blood pressure 24 hour variability (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'nocturnal systolic and diastolic BP dip; standard deviation of systolic and diastolic BP; weighted standard deviation of systolic and diastolic BP; mmHg'}, {'measure': 'Arterial stiffness (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'carotid-femoral pulse wave velocity; m/s'}, {'measure': 'Adiposity (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'BMI; kg/m2'}, {'measure': 'Adiposity (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'waist-hip-ratio (no unit)'}, {'measure': 'Adiposity (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'body fat percentage; %'}, {'measure': 'Dietary intake (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'food frequency questionnaire on quality of fat (SFA, MUFA and PUFA; E%/day)'}, {'measure': 'Dietary intake (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'food frequency questionnaire on fiber intake; g/day'}, {'measure': 'Dietary intake (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'food frequency questionnaire on salt intake; g/d'}, {'measure': 'Physical activity and sedentary behavior (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: weekly number of sessions and minutes of moderate-to-vigorous-intensity physical activity and walking'}, {'measure': 'Physical activity and sedentary behavior (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: meeting physical activity recommendations'}, {'measure': 'Physical activity and sedentary behavior (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: daily minutes of sitting on a non-weekend and weekend day'}, {'measure': 'Physical activity and sedentary behavior (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily number of steps'}, {'measure': 'Physical activity and sedentary behavior (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily minutes of total and intensity-specific physical activity'}, {'measure': 'Physical activity and sedentary behavior (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily minutes of stationary behavior'}, {'measure': 'Physical activity and sedentary behavior (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily number of breaks in stationary behavior'}, {'measure': 'Smoking (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire on status of smoking/use of snuf/use of electronic cigarettes/nicotine replacement therapy and number of cigarettes/day'}, {'measure': 'Laboratory assessment of cardiovascular risk (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)'}, {'measure': 'Laboratory assessment of cardiovascular risk (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'hs-CRP; mg/l'}, {'measure': 'Laboratory assessment of cardiovascular risk (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5'}, {'measure': 'Awareness of later life morbidity (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'A brief questionnaire with true or false questions on pre-eclampsia and later life morbidity'}, {'measure': 'Heart rate variability (mothers)', 'timeFrame': 'baseline -12 months', 'description': 'standard deviation of all R-R intervals; root mean square of successive R-R interval differences, ms; High frequency power of R-R intervals from spectral band 0.15-0.4 Hz, ms2 ;Low frequency power of R-R intervals from spectral band 0.04-0.15 Hz, ms2 ; and LF/HF ratio'}, {'measure': 'Blood pressure 24 hour variability (children)', 'timeFrame': 'baseline -12 months', 'description': 'nocturnal systolic and diastolic BP dip; standard deviation of systolic and diastolic BP; weighted standard deviation of systolic and diastolic BP; mmHg'}, {'measure': 'Arterial stiffness (children)', 'timeFrame': 'baseline -12 months', 'description': 'carotid-femoral pulse wave velocity; m/s'}, {'measure': 'Adiposity (children)', 'timeFrame': 'baseline -12 months', 'description': 'BMI z-score'}, {'measure': 'Adiposity (children)', 'timeFrame': 'baseline -12 months', 'description': 'waist-hip-ratio (no unit)'}, {'measure': 'Adiposity (children)', 'timeFrame': 'baseline -12 months', 'description': 'body fat percentage; %'}, {'measure': 'Dietary intake (children)', 'timeFrame': 'baseline -12 months', 'description': 'food frequency questionnaire derived data on SFA index, fiber index, salt index (sum of food items rich in SFA/fiber/salt used during the previous week)'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: weekly number of days and daily duration of active travel to school and hobbies, structured physical activity outside school hours, unstructured physical activity outside school hours, screen time sitting, non-screen time sitting Accelerometer data: daily number of steps; daily minutes of total and intensity-specific physical activity; daily minutes of and stationary behavior; meeting physical activity recommendations; daily number of breaks in stationary behavior'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: weekly number of days and daily duration of active travel to school and hobbies'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: structured physical activity outside school hours'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: unstructured physical activity outside school hours'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'questionnaire data: screen time and non-screen time sitting'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily number of steps'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily minutes of total and intensity-specific physical activity'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily minutes of stationary behavior'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: meeting physical activity recommendations'}, {'measure': 'Physical activity and sedentary behavior (children)', 'timeFrame': 'baseline -12 months', 'description': 'accelerometer data: daily number of breaks in stationary behavior'}, {'measure': 'Laboratory assessment of cardiovascular risk (children)', 'timeFrame': 'baseline -12 months', 'description': 'lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l)'}, {'measure': 'Laboratory assessment of cardiovascular risk (children)', 'timeFrame': 'baseline -12 months', 'description': 'hs-CRP; mg/l'}, {'measure': 'Laboratory assessment of cardiovascular risk (children)', 'timeFrame': 'baseline -12 months', 'description': 'HOMA index calculated as glucose; mmol/l x insulin; mU/l / 22.5'}, {'measure': 'Process evaluation: reach', 'timeFrame': 'baseline', 'description': 'participation rate of the families recruited (research database on study visits)'}, {'measure': 'Process evaluation: reach', 'timeFrame': 'baseline', 'description': "representativeness of the families participating (parents' and children's age, questionnaire on socio-economics)"}, {'measure': 'Process evaluation: compliance', 'timeFrame': 'baseline -12 months', 'description': 'participation rate in measurements (number of study visits and questionnaires completed)'}, {'measure': 'Process evaluation: compliance', 'timeFrame': 'baseline -12 months', 'description': 'proportion of sessions completed in the web-based portal (data accumulated in the web-based portal)'}, {'measure': 'Process evaluation: acceptability', 'timeFrame': 'baseline -12 months', 'description': 'usefulness and ease of use (questionnaire and proportion of webportal sessions completed by the families)'}, {'measure': 'Process evaluation: acceptability', 'timeFrame': 'baseline -12 months', 'description': 'credibility and satisfaction of the web-based portal (questionnaire and proportion of webportal sessions completed by the families)'}, {'measure': 'Process evaluation: acceptability', 'timeFrame': 'baseline -12 months', 'description': 'occurrence of technical problems (questionnaire)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia', 'Cardiovascular Diseases', 'Cardiovascular Risk Factor', 'Gestational Hypertension']}, 'referencesModule': {'references': [{'pmid': '28067621', 'type': 'RESULT', '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.'}, {'pmid': '39011963', 'type': 'DERIVED', 'citation': 'Renlund-Vikstrom M, Jaaskelainen TJ, Kivela A, Heinonen S, Laivuori H, Sarkola T. Cardiac Structure and Function in 8- to 12-Year-Old Children Following In-Utero Exposure to Preeclampsia (FINNCARE Study). J Am Heart Assoc. 2024 Aug 6;13(15):e034494. doi: 10.1161/JAHA.124.034494. Epub 2024 Jul 16.'}, {'pmid': '37337860', 'type': 'DERIVED', 'citation': 'Renlund MA, Jaaskelainen TJ, Kivela ASE, Heinonen ST, Laivuori HM, Sarkola TA. Blood pressure, arterial stiffness, and cardiovascular risk profiles in 8-12-year-old children following preeclampsia (FINNCARE-study). J Hypertens. 2023 Sep 1;41(9):1429-1437. doi: 10.1097/HJH.0000000000003485. Epub 2023 Jun 19.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAim: 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.\n\nHypothesis: 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.\n\nStudy 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.\n\nMain outcome: 24 hour mean blood pressure change between baseline and follow-up in mother and child.\n\nSignificance: 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.', 'detailedDescription': 'Power analysis:\n\nPower 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.\n\nSpecific objectives:\n\n1. 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.\n2. 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.\n3. To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFamilies 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.\n\nExclusion criteria in the FINNPEC: multiple pregnancy, inability to speak Finnish or Swedish.\n\nExclusion Criteria in the FINNCARE:\n\n* Pregnancy and/or lactation (for all mothers)\n* Pre-eclampsia in any previous or subsequent pregnancies (for all non-PE mothers)'}, 'identificationModule': {'nctId': 'NCT04676295', 'acronym': 'FINNCARE', 'briefTitle': 'Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health', 'orgStudyIdInfo': {'id': 'FINNCARE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PE intervention', 'description': 'A 12-month lifestyle intervention program to improve mothers and their children blood pressure and CVD risk profile.', 'interventionNames': ['Behavioral: Face-to-face and web-based lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'PE control', 'description': 'The control group continue habitual lifestyle but will perform the same baseline and follow-up measurements as the intervention group. They will be given general written information on healthy eating.'}, {'type': 'NO_INTERVENTION', 'label': 'Non-PE control', 'description': 'The control group continue habitual lifestyle but will perform the same baseline and follow-up measurements as the intervention group. They will be given general written information on healthy eating.'}], 'interventions': [{'name': 'Face-to-face and web-based lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Families are provided at baseline with one 60 min face-to-face dietary counseling session with nutritionist using family-oriented motivational interviewing and solution focusing techniques. The intervention continues in an interactive web-based portal where different modules include assignments, activities, and tests and related videos targeting five cardiovascular health-linked behaviors: 1) improving quality of fat in the diet, 2) increasing the consumption of foods rich in fiber, 3) decreasing the use of salt, 4) increasing physical activity and 5) reducing smoking.', 'armGroupLabels': ['PE intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Taisto Sarkola, PhD, MD', 'role': 'CONTACT', 'email': 'taisto.sarkola@hus.fi', 'phone': '+358504274971'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Tiina Jääskeläinen, PhD', 'role': 'CONTACT', 'email': 'tiina.j.jaaskelainen@helsinki.fi', 'phone': '+358 50 4150274'}, {'name': 'Taisto Sarkola, PhD, MD', 'role': 'CONTACT', 'email': 'taisto.sarkola@hus.fi', 'phone': '+358504274971'}], 'overallOfficials': [{'name': 'Tiina Jääskeläinen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Helsinki'}, {'name': 'Hannele Laivuori, Prof, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Helsinki and University of Tampere'}, {'name': 'Taisto Sarkola, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tiina Jääskeläinen', 'investigatorAffiliation': 'University of Helsinki'}}}}