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

NCT ID: NCT03323762

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-24
• Study Completion Date: 2020-08-28

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.

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.

Conditions

Pre-Eclampsia; Mild; Gestational Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote Ischaemic Conditioning (RIC)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Randers Regional Hospital

OTHER

Sponsor Role: collaborator

Herning Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulla Kristine Møller Liendgaard, Phd, MHSc.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University hospital

Aarhus, , Denmark

Herning Hospital

Herning, , Denmark

Randers Hospital

Randers, , Denmark

Countries

Denmark

Other Identifiers

RIC & pre-eclampsia

Identifier Type: -

Identifier Source: org_study_id