Swiss Postpartum Hypertension Cohort

NCT04690660 | Recruiting

• 1 other identifier: 2020-00736; me20Burkard
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hypertension (PPHT)

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

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

Data collection for parameters of organ damage (cardiac and renal blood markers) OTHER

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.

Data collection for blood pressure (BP) OTHER

Clinic blood pressure and 24hour BP Measurements

Home-based blood pressure management (substudy) OTHER

Subjects participating in home-based blood pressure management via telemonitoring will receive a free HekaHealth application (App) for the structured assessment of HBPM.

Biomarker Profiles (substudy) OTHER

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).

Data collection on patient reported outcomes OTHER

Data collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will take place at the Hypertension Clinic of the Medical Outpatient Department at the University Hospital Basel and the Department of Obstetrics and Gynaecology at the University Hospital Basel. Participants will be consecutively screened and recruited by the treating physicians and the Hypertension Team of the Hypertension Clinic.

You may qualify if:

• 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

You may not qualify if:

• delivery \> 14 days
• lack of consent to participate in the study, language barriers or lack of general understanding

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Medical Outpatient Department and Hypertension Clinic, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for biomarker

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Alzheimer Disease

Interventions

Data Collection; Blood Pressure

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Thenral Socrates, Dr. med.

  Medical Outpatient Department and Hypertension Clinic, University Hospital BaselUni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thenral Socrates, Dr. med.

CONTACT

+41 61 328 6647; thenral.socrates@usb.ch

Thilo Burkard, Dr. med.

CONTACT

+41 61 328 7738; thilo.burkard@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 31, 2020
• Study Start: June 4, 2020
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CH (1)