Basel Postpartum Hypertension Cohort

Study Overview
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Brief Summary
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This open label, prospective observational, single-center registry is to study short-, intermediate-and long-term course of postpartum hypertension and predictors/risk factors associated with long term cardiovascular and renal risk. Current disease management strategies will be evaluated.

Official Title
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Basel Postpartum Hypertension Cohort (Basel-PPHT)

Conditions
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Postpartum Hypertension (PPHT)

Intervention / Treatment
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* Other: Data collection for parameters of organ damage (cardiac and renal blood markers)
* Other: Data collection for blood pressure (BP)
* Other: Home-based blood pressure management (substudy)
* Other: Biomarker Profiles (substudy)
* Other: Data collection on patient reported outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all women with hypertensive disorders of pregnancy postpartum hypertension (blood pressure measurements of systolic ≥140 and/or diastolic ≥ 90mmHg or antihypertensive therapy within the first 14 days after delivery) women with preexisting hypertension or women on antihypertensive medication Exclusion Criteria: delivery > 14 days lack of consent to participate in the study, language barriers or lack of general understanding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection for parameters of organ damage (cardiac and renal blood markers)|Blood results will be taken out of next routine venipuncture. Routinely collected standard parameters are a blood count, chemistry panel including renal parameters and electrolytes, lipid profile and a HbA1c as well as albumin/creatinine and protein/creatinine ratio in urine.|
|Other: Data collection for blood pressure (BP)|Clinic blood pressure and 24hour BP Measurements|
|Other: Home-based blood pressure management (substudy)|Subjects participating in home-based blood pressure management via telemonitoring will receive a free HekaHealth application (App) for the structured assessment of HBPM.|
|Other: Biomarker Profiles (substudy)|Substudy where possible cardiac, renal and pregnancy related biomarkers will be additionally analyzed. The following biomarkers will be analyzed: N terminal (NT)-proBNP, Troponin, elevated mid-regional pro-atrial natriuretic peptide (ANP), elevated mid-regional pro adrenomedullin (ADM), soluble fms-like tyrosine kinase (sFlt-1), and placenta growth factor (PlGF).|
|Other: Data collection on patient reported outcomes|Data collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of persistent hypertension defined by 24 hours BP measurement | Frequency of persistent hypertension defined by 24 hours BP measurement | through study completion, an average of 5 years | 
| Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM) | Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM) | through study completion, an average of 5 years | 
| Frequency of microalbuminuria | Frequency of microalbuminuria | through study completion, an average of 5 years | 
| Frequency of damage to the retina of the eyes (retinopathy) | Frequency of damage to the retina of the eyes (retinopathy) | through study completion, an average of 5 years | 
| Signs of hypertensive heart disease | Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH) | up to 24 months | 
| Frequency of dyslipidemia | Frequency of dyslipidemia | through study completion, an average of 5 years | 
| Frequency of prediabetes/diabetes | Frequency of prediabetes/diabetes | through study completion, an average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy Induced Hypertension (PIH), Home Blood Pressure Monitoring (HBPM), Office Blood Pressure Monitoring (OBPM), Automated Office Blood Pressure Measurement (AOBPM), Gestational Hypertension, HekaHealth Self-Measured Blood Pressure (SMBP) App