Basel Postpartum Hypertension Cohort (Basel-PPHT)

Basel Postpartum Hypertension Cohort (Basel-PPHT)

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Hypertension (PPHT)
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

• Study Contact: Name: Thilo Burkard, Dr. med.; Phone Number: +41 61 328 7738; Email: thilo.burkard@usb.ch
• Study Contact Backup: Name: Thenral Socrates, Dr. med.; Phone Number: +41 61 328 6647; Email: thenral.socrates@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Medical Outpatient Department and Hypertension Clinic, University Hospital Basel
    • Contact: Thenral Socrates, Dr. med.; Phone Number: +41 61 328 6647; Email: thenral.socrates@usb.ch
    • Sub-Investigator: Irene Hösli, Prof. Dr. med.
    • Sub-Investigator: Olav Lapaire, Prof. Dr. med.
    • Sub-Investigator: Michael Mayr, PD Dr. med.
    • Principal Investigator: Thenral Socrates, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Thenral Socrates, Dr. med., Medical Outpatient Department and Hypertension Clinic, University Hospital BaselUni

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Gestational Hypertension; Pregnancy Induced Hypertension (PIH); Home Blood Pressure Monitoring (HBPM); Office Blood Pressure Monitoring (OBPM); Automated Office Blood Pressure Measurement (AOBPM); HekaHealth Self-Measured Blood Pressure (SMBP) App
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2020-00736; me20Burkard

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No