Postpartum Hypertension (PPHT)NCT04690660
Swiss Postpartum Hypertension Cohort
An observational study of Postpartum Hypertension (PPHT), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hypertension (PPHT)
- What is being tested?
- Data collection for parameters of organ damage (cardiac and renal blood markers), Data collection for blood pressure (BP) and Home-based blood pressure management (substudy)
- How many people
- 480 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jun 2020to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- delivery > 14 days
- lack of consent to participate in the study, language barriers or lack of general understanding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Medical Outpatient Department and Hypertension Clinic, University Hospital Basel
Basel, 4031
Thenral Socrates, Dr. med., +41 61 328 6647, thenral.socrates@usb.ch
Thenral Socrates, Dr. med.
About this study
Official title: Swiss Postpartum Hypertension Cohort (Swiss-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.
- Conditions
- Postpartum Hypertension (PPHT)
- Being tested
- 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), Data collection on patient reported outcomes
- 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
- Medical subject headings
- Hypertension, Pregnancy-Induced, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 outcomesOther
Data collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of persistent hypertension defined by 24 hours BP measurement
Frequency of persistent hypertension defined by 24 hours BP measurement
Measured: 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)
Measured: through study completion, an average of 5 years
Frequency of microalbuminuria
Frequency of microalbuminuria
Measured: 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)
Measured: 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)
Measured: up to 24 months
Frequency of dyslipidemia
Frequency of dyslipidemia
Measured: through study completion, an average of 5 years
Frequency of prediabetes/diabetes
Frequency of prediabetes/diabetes
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start4 Jun 2020
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hypertension (PPHT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thenral Socrates, Dr. med., Principal investigator, Medical Outpatient Department and Hypertension Clinic, University Hospital BaselUni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690660
- Sponsor's protocol ID
- 2020-00736; me20Burkard
- Status last verified
- May 2025
- First submitted
- 15 Dec 2020
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Postpartum Hypertension Cohort (Swiss-PPHT)
- ClinicalTrials.gov ID
- NCT04690660
- Acronym / sponsor ID
- 2020-00736; me20Burkard
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- delivery > 14 days
- lack of consent to participate in the study, language barriers or lack of general understanding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 outcomesData collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring ) | Other | – |
Primary outcome
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 24 hours BP measurement
Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM)
Time frame: through study completion, an average of 5 years
Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM)
Frequency of microalbuminuria
Time frame: through study completion, an average of 5 years
Frequency of microalbuminuria
Frequency of damage to the retina of the eyes (retinopathy)
Time frame: through study completion, an average of 5 years
Frequency of damage to the retina of the eyes (retinopathy)
Signs of hypertensive heart disease
Time frame: up to 24 months
Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH)
Frequency of dyslipidemia
Time frame: through study completion, an average of 5 years
Frequency of dyslipidemia
Frequency of prediabetes/diabetes
Time frame: through study completion, an average of 5 years
Frequency of prediabetes/diabetes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thenral Socrates, Dr. med. principal investigator
Medical Outpatient Department and Hypertension Clinic, University Hospital BaselUni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hypertension (PPHT), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thenral Socrates, Dr. med. (+41 61 328 6647, thenral.socrates@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of persistent hypertension defined by 24 hours BP measurement (time frame: through study completion, an average of 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.