Basel Postpartum Hypertension Cohort

Postpartum Hypertension (PPHT) Clinical Trial

— Basel-PPHT  

Official title:

Basel Postpartum Hypertension Cohort (Basel-PPHT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690660
• Other study ID #: 2020-00736; me20Burkard
• Status: Recruiting
• Start date: June 4, 2020
• Est. completion date: May 2030

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Thenral Socrates, Dr. med.
• Phone: +41 61 328 6647
• Email: thenral.socrates[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 2030
• Est. primary completion date: May 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Postpartum Hypertension (PPHT)

Intervention

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.
• Data collection for blood pressure (BP)
Clinic blood pressure and 24hour BP Measurements
• 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.
• 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).
• Data collection on patient reported outcomes
Data collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )

Locations

Country	Name	City	State
Switzerland	Medical Outpatient Department and Hypertension Clinic, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Frequency of microalbuminuria	Frequency of microalbuminuria	through study completion, an average of 5 years
Primary	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
Primary	Signs of hypertensive heart disease	Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH)	up to 24 months
Primary	Frequency of dyslipidemia	Frequency of dyslipidemia	through study completion, an average of 5 years
Primary	Frequency of prediabetes/diabetes	Frequency of prediabetes/diabetes	through study completion, an average of 5 years