Pre-Eclampsia; MildNCT03323762
Effect of RIC on BP and Inflammatory Response in Women With Pre-eclampsia
A study testing Remote Ischaemic Conditioning (RIC) in people with Pre-Eclampsia; Mild and Gestational Hypertension, run by University of Aarhus at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia; Mild, Gestational Hypertension
- What is being tested?
- Remote Ischaemic Conditioning (RIC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesDenmark
- Study dates
- 24 Oct 2017to 28 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Systolic blood pressure above 140 and/or
- Diastolic blood pressure above 85
- Proteinuria +/-
- Clinical signs / symptoms +/-
- Clinical signs and symptoms of pre-eclampsia +/-
Who cannot join
- Eclampsia
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University hospital
Aarhus, 8200
Herning Hospital
Herning, 7400
Randers Hospital
Randers, 8930
About this study
Official title: Effect of Remote Ischemic Conditioning on Blood Pressure and Inflammatory Response in Women With Pre-eclampsia and Gestational Hypertension
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.
Read the 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
- Being tested
- Remote Ischaemic Conditioning (RIC)
- Keywords
- Pre-Eclampsia; Mild, Pre-Eclampsia; Moderate, Gestational Hypertension, Remote ischemic conditioning
- Medical subject headings
- Pre-Eclampsia, Lymphoma, Follicular, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischaemic Conditioning (RIC)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
| Study group | Role | What they receive |
|---|---|---|
| RIC | Experimental | 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. Receives: Device: Remote Ischaemic Conditioning (RIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median arterial blood pressure
Median arterial blood pressure after 6 days of treatment
Measured: after 6 days of treatment
Secondary outcomes (2)
The inflammatory response
Changes in the inflammatory response after 6 days of treatment
Measured: after 6 days of treatment
Medication
prescription of antihypertensive
Measured: After 6 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start24 Oct 2017
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Eclampsia; MildStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Herning Hospital
- Responsible party
- Sponsor
- Investigators
- Ulla Kristine Møller Liendgaard, Phd, MHSc., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323762
- Sponsor's protocol ID
- RIC & pre-eclampsia
- Status last verified
- Jan 2019
- First submitted
- 24 Oct 2017
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Conditioning on Blood Pressure and Inflammatory Response in Women With Pre-eclampsia and Gestational Hypertension
- ClinicalTrials.gov ID
- NCT03323762
- Acronym / sponsor ID
- RIC & pre-eclampsia
- Conditions
- Pre-Eclampsia; Mild, Gestational Hypertension
- Keywords
- Pre-Eclampsia; Mild, Pre-Eclampsia; Moderate, Gestational Hypertension, Remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Herning Hospital
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 27 Oct 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIC | Experimental | Device: Remote Ischaemic Conditioning (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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systolic blood pressure above 140 and/or
- Diastolic blood pressure above 85
- Proteinuria +/-
- Clinical signs / symptoms +/-
- Clinical signs and symptoms of pre-eclampsia +/-
Key exclusion criteria (1 listed)
- Eclampsia
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 |
|---|---|---|
| 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 | Device | RIC |
Primary outcome
Median arterial blood pressure
Time frame: after 6 days of treatment
Median arterial blood pressure after 6 days of treatment
2 secondary outcomes
The inflammatory response
Time frame: after 6 days of treatment
Medication
Time frame: After 6 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
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Dipyridamole for Early-Onset Preeclampsia: A Pilot Study of Feasibility, Pharmacokinetics, and Biological Effects
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PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
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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. This study is not recruiting at the moment.
Ulla Kristine Møller Liendgaard, Phd, MHSc. principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischaemic Conditioning (RIC) in people with Pre-Eclampsia; Mild and Gestational Hypertension, run by University of Aarhus at 3 sites in Denmark.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median arterial blood pressure (time frame: after 6 days of treatment). 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 6 Jan 2021.