Effect of RIC on BP and Inflammatory Response in Women With Pre-eclampsia

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ClinicalTrials.gov Identifier: NCT03323762

Recruitment Status : Completed

First Posted : October 27, 2017

Last Update Posted : January 6, 2021

Sponsor:

Collaborators:

Randers Regional Hospital

Herning Hospital

Information provided by (Responsible Party):

University of Aarhus

Study Description

Brief Summary:

The aim of this pilot cohort study is to investigate whether treatment with remote ischemic conditioning (RIC) has a beneficial effect on blood pressure as well as the immune system in pregnant women with newly diagnosed hypertension (> 140/58 mm Hg) or pre-eclampsia before gestational week 37+3.

Condition or disease	Intervention/treatment	Phase
Pre-Eclampsia; Mild Gestational Hypertension	Device: Remote Ischaemic Conditioning (RIC)	Not Applicable

Show detailed description

Detailed Description:

Pre-eclampsia, which affects about 2 to 7% of pregnancies, is a major cause of maternal and perinatal morbidity and mortality.

The onset of clinical symptoms (hypertension, proteinuria or end- organ dysfunction), are often seen in the last trimester of a pregnancy.

The disease can have major consequences for both the child and the mother. Yet there are only very limited treatment options, where induced labour is the only healing treatment. Today, the treatment consists in limiting blood pressure increase with medical treatment, whereby the pregnancy most often can result in term delivery.

Remote Ischaemic Conditioning (RIC) achieved by an automatic inflation of a blood pressure cuff to induce four 5-minute cycles of limb ischaemia and reperfusion, is a treatment that has been found to decrease the inflammatory response and lower blood pressure in states of myocardial infarction, chronic heart failure, and stroke.

The treatment is virtually a cost-free non-pharmacological and non-invasive therapeutic strategy performed by the patient herself in her home.

However, whether RIC actually can improve clinical outcomes in relation to lowering blood pressure and the inflammatory response in pregnant women with newly diagnosed hypertension is yet to be investigated.

Aim and endpoint:

The aim of this pilot cohort study is to investigate whether treatment with remote ischemic conditioning (RIC) has a beneficial effect on blood pressure as well as the immune system in pregnant women with newly diagnosed hypertension (> 140/58mm Hg) or pre-eclampsia before gestational week 37+3.

Primary end-point • Median arterial blood pressure after 6 days of treatment

Secondary end-point

• Changes in the inflammatory response

Design and method:

In a pilot cohort study at Aarhus University Hospital, Regional Hospital Randers and Region Hospital Herning 20 pregnant women with signs of gestational hypertension or pre-eclampsia (systolic blood pressure above 140 and / or diastolic blood pressure over 85; +/- proteinuria, +/- clinical signs or subjective symptoms and signs) are to be enrolled.

The study flowchart:

Newly hospital referred women with signs of gestational hypertension or pre-eclampsia will be asked to participate. Informed consent will be obtained and blood pressure, blood samples, and weight will be measured.

Day 1: resting day at home - blood pressure measuring
Day 2-7: Morning: Blood pressure measuring and RIC treatment. Evening: blood pressure measuring
Day 7: In hospital: Blood samples and weight will be measured.

Pros and cons:

In relation to the inflation of the blood pressure cuff temporary moderate pains in the treated arm might occur. Otherwise, the RIC is without side effects. Two extra blood samples of app. 50 ml each will be drawn, with a small risk of local infection exist.

The usefulness of the study The study is designed as a small pilot study. In which the set up will be tested and the effects on blood pressure and the inflammatory response in a relative small size will be explored. A larger randomised study will follow if the results show a positive trend.

Positive as well as negative and inconclusive results will be widely disseminated through national and international scientific journals and conferences.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Remote Ischemic Conditioning on Blood Pressure and Inflammatory Response in Women With Pre-eclampsia and Gestational Hypertension
Actual Study Start Date :	October 24, 2017
Actual Primary Completion Date :	August 28, 2020
Actual Study Completion Date :	August 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension Preeclampsia

MedlinePlus related topics: High Blood Pressure in Pregnancy

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: RIC RIC treatment arm The CellAegis auto RIC (automated blood pressure cuff) will be placed on the upper arm and inflated to 200 mmHg for 5 minutes followed by 5 minutes of deflation. The programmed cycle is repeated 4 times in total, summing up to a total treatment length of 35 minutes. The treatment will be carried out on the morning of day 2 to day 7 by the participants themselves at their home.	Device: Remote Ischaemic Conditioning (RIC) The CellAegis auto RIC (automated blood pressure cuff) will be placed on the upper arm and inflated to 200 mmHg for 5 minutes followed by 5 minutes of deflation. The programmed cycle is repeated 4 times in total, summing up to a total treatment length of 35 minutes

Arm

Intervention/treatment

Experimental: RIC

RIC treatment arm The CellAegis auto RIC (automated blood pressure cuff) will be placed on the upper arm and inflated to 200 mmHg for 5 minutes followed by 5 minutes of deflation. The programmed cycle is repeated 4 times in total, summing up to a total treatment length of 35 minutes.

The treatment will be carried out on the morning of day 2 to day 7 by the participants themselves at their home.

Device: Remote Ischaemic Conditioning (RIC)

The CellAegis auto RIC (automated blood pressure cuff) will be placed on the upper arm and inflated to 200 mmHg for 5 minutes followed by 5 minutes of deflation. The programmed cycle is repeated 4 times in total, summing up to a total treatment length of 35 minutes

Outcome Measures

Primary Outcome Measures :

Median arterial blood pressure [ Time Frame: after 6 days of treatment ]
Median arterial blood pressure after 6 days of treatment

Secondary Outcome Measures :

The inflammatory response [ Time Frame: after 6 days of treatment ]
Changes in the inflammatory response after 6 days of treatment
Medication [ Time Frame: After 6 days of treatment ]
prescription of antihypertensive

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Obs pre-eclampsia
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Systolic blood pressure above 140 and/or
Diastolic blood pressure above 85
Proteinuria +/-
Clinical signs / symptoms +/-

Clinical signs and symptoms of pre-eclampsia +/-

Exclusion Criteria:

• Eclampsia

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323762

Locations

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Denmark
Aarhus University hospital
Aarhus, Denmark, 8200
Herning Hospital
Herning, Denmark, 7400
Randers Hospital
Randers, Denmark, 8930

Sponsors and Collaborators

University of Aarhus

Randers Regional Hospital

Herning Hospital

Investigators

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Principal Investigator:	Ulla Kristine Møller Liendgaard, Phd, MHSc.	Aarhus University Hospital

More Information

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Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT03323762
Other Study ID Numbers:	RIC & pre-eclampsia
First Posted:	October 27, 2017 Key Record Dates
Last Update Posted:	January 6, 2021
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University of Aarhus:


Pre-Eclampsia; Mild Pre-Eclampsia; Moderate Gestational Hypertension Remote ischemic conditioning

Additional relevant MeSH terms:

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Eclampsia Pre-Eclampsia Hypertension, Pregnancy-Induced Hypertension	Vascular Diseases Cardiovascular Diseases Pregnancy Complications

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