Pilot Project Renal and Cardiovascular Tertiary Preventio... | NCT07151339

Studies
Pilot Project Renal and Cardiovascular Tertiary Prevention in Preeclampsia

NCT07151339

Sponsor

University Hospital Schleswig-Holstein

Status

Recruiting

Last Update Posted

Sep 3, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Preeclampsia
HELLP Syndrome
Eclampsia
Kidney Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

Nov 2030Estimated

First Submitted Date

Aug 20, 2025

First Submission Date that Met QC Criteria

Aug 28, 2025

First Posted Date

Sep 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2025

Last Update Posted Date

Sep 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laura Katharina Sievers, Principal Investigator, University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Tertiary prevention program for women with preeclampsia, HELLP syndrome, kidney disease and pregnancy or associated conditions, including founding of a biobank. (Observational study since no interference with regular path of treatment suggested in national and international guidelines)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Measure	Description	Time Frame
Pulse wave velocity		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

older than 18 yrs
diagnosed preeclampsia, HELLP syndrome or kidney disease durig pregnancy

Exclusion Criteria:

unable for informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women during pregnancy

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

women with preeclampsia/HELLP syndrome/kidney disease during pregnancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura K Sievers, MD	Contact	+49 431 500 23001		Laura.Rakow@uksh.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Schleswig- Holstein	Recruiting	Kiel		24105	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D017359	HELLP Syndrome
D004461	Eclampsia
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided