Postpartum Hypertension (PPHT)
Conditions
Keywords
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
Brief summary
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.
Interventions
OTHERData 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.
OTHERData collection for blood pressure (BP)
Clinic blood pressure and 24hour BP Measurements
OTHERHome-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.
OTHERBiomarker 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).
OTHERData collection on patient reported outcomes
Data collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of persistent hypertension defined by 24 hours BP measurement | through study completion, an average of 5 years | Frequency of persistent hypertension defined by 24 hours BP measurement |
| Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM) | through study completion, an average of 5 years | Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM) |
| Frequency of microalbuminuria | through study completion, an average of 5 years | Frequency of microalbuminuria |
| Frequency of damage to the retina of the eyes (retinopathy) | through study completion, an average of 5 years | Frequency of damage to the retina of the eyes (retinopathy) |
| Signs of hypertensive heart disease | up to 24 months | Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH) |
| Frequency of dyslipidemia | through study completion, an average of 5 years | Frequency of dyslipidemia |
| Frequency of prediabetes/diabetes | through study completion, an average of 5 years | Frequency of prediabetes/diabetes |
Countries
Switzerland
Contacts
Primary ContactThenral Socrates, Dr. med.
Backup ContactThilo Burkard, Dr. med.
Outcome results
None listed