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Recruiting NCT04690660

Swiss Postpartum Hypertension Cohort

— Observational Postpartum Hypertension (PPHT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection for parameters of organ damage (cardiac and renal blood markers), Data collection for blood pressure (BP), Home-based blood pressure management (substudy), Biomarker Profiles (substudy).
Who it may be relevant to
Registry conditions: Postpartum Hypertension (PPHT). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Swiss Postpartum Hypertension Cohort (Swiss-PPHT)

Overview

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

  • 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 )

Primary outcome measures

  • Frequency of persistent hypertension defined by 24 hours BP measurement [Time frame: through study completion, an average of 5 years]
  • Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM) [Time frame: through study completion, an average of 5 years]
  • Frequency of microalbuminuria [Time frame: through study completion, an average of 5 years]
  • Frequency of damage to the retina of the eyes (retinopathy) [Time frame: through study completion, an average of 5 years]
  • Signs of hypertensive heart disease [Time frame: up to 24 months]
  • Frequency of dyslipidemia [Time frame: through study completion, an average of 5 years]
  • Frequency of prediabetes/diabetes [Time frame: through study completion, an average of 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Medical Outpatient Department and Hypertension Clinic, University Hospital Basel — Basel

Identifiers

NCT: NCT04690660 · 2020-00736; me20Burkard

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗