PreeclampsiaHUPPNCT01828138
Hypertension and Urine Protease Activity in Preeclampsia
A study testing Sodium in people with Preeclampsia and Hypertension, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Preeclampsia (PE) is a common disorder of pregnancy that complicates 4-7% of all pregnancies. It is a serious condition with acute proteinuria and hypertension and varying degrees of edema after 20 weeks of gestation. PE leads to a severe risk of low birth weight because of prematurity with inherent complications. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Hypertension, Proteinuria
- What is being tested?
- Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Oct 2015
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy week 28-36 (exclusion of patients with previously severe preeclampsia).
- Singleton pregnancy
- Preeclampsia- hypertension: repetitive high blood pressures (> 140/80 mm Hg) measured in the consultation and proteinuria (dip test, albumin).
- Pregnant with microalbuminuria and proteinuria, but without hypertension (and therefore do not meet the diagnostic criteria for preeclampsia) can also be included. Proteinuria is the most important factor.
- It is still possible to test our hypothesis with possible comorbidity such as diabetes, SLE(systemic lupus erythematosus), rheumatoid arthritis and therefore not a reason for exclusion.
- pregnancy week 28-36
Show all 10Show fewer
- Singleton pregnancy
- Uncomplicated pregnancy
- woman, not pregnant
- Matched by age and BMI
Who cannot join
- Hypertension in pregnancy without proteinuria.
- Pregestational nephropathy by other unknown reasons.
- Early severe preeclampsia.
- Organic or systemic disease of clinical relevance, such as malignancy.
- Pregnant controls-
- Hypertension
Show all 12Show fewer
- Any kind of nephropathy
- Organic or systemic disease of clinical relevance, such as malignancy.
- Non-pregnant controls:
- Hypertension
- Any kind of nephropathy
- Organic or systemic disease of clinical relevance, such as malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HUPP-study -Hypertension and Urine Protease Activity in Preeclampsia
Preeclampsia (PE) is a common disorder of pregnancy that complicates 4-7% of all pregnancies. It is a serious condition with acute proteinuria and hypertension and varying degrees of edema after 20 weeks of gestation. PE leads to a severe risk of low birth weight because of prematurity with inherent complications. The pathogenesis is unknown but is assumed to involve placental ischemia.The primary placental disorder results in renal glomerular injury. Established PE is associated with paradoxical suppression of the renin-angiotensin-aldosterone system, RAAS.
Despite suppressed RAAS, patients with PE retain NaCl(sodium chloride) after an intravenous isotonic NaCl overload compared to healthy pregnant women on a low NaCl diet. The investigators believe to have data that provide a possible explanation for the overall relationship between proteinuria, NaCl retension, suppression of RAAS, hypertension and underdevelopment of placenta. Earlier data, which the investigators have confirmed, shows abnormal glomerular loss of the enzyme plasmin/plasminogen from plasma to the urine in PE. Active plasmin in urine from patients with nephrotic syndrome and PE activates the epithelial sodium channel ( ENaC ) in renal collecting duct cells. The investigators hypothesize that loss of plasmin/plasminogen are shared for the diseases with proteinuria, including PE, and that plasmin- driven ENaC (epithelial sodium channel) activation is a causal factor in the pathophysiology of established PE. Hyperactive ENaC causes primary renal sodium retention with secondary suppression of the renin-angiotensin-aldosterone system. Aldosterone is recently established as a placental growth factor.
Read more
Plasma-aldosterone levels are significant higher in normal pregnant women. PE is characterized by low aldosterone levels (a discovery the investigators have also confirmed) and by placental underdevelopment.
Study Aim: To test specific hypothesis regarding established PE´s pathophysiological mechanisms.
Study Hypothesis:
- Excretion of urine proteases (plasmin/plasminogen) in PE leads to an activation of ENaC and hence RAAS is less NaCl sensitive while the blood pressure is more NaCl sensitive compared to healthy pregnant women.
- The degree of aldosterone suppression in PE determines placental development
Read the detailed description
Selection of patients:
The selection of patients is based on outpatients with preeclampsia and patients with normal pregnancies recruited from gynecological-obstetric department, Aarhus University Hospital - Skejby, Denmark. Non- pregnant woman are recruited by posting notices at the workplace. Specifically by office facilities, canteen and in gynecological department at Skejby hospital, Aarhus.
Background information:
Registration of date of birth, sex, weight, height, abdominal circumference, and smoking status will be noted.
Furthermore, we will register current antihypertensive-, diuretic-, antidiabetic- and antiepileptic medicine and other current use of medicine. Also post-partum registration of gestation length, placentas weight and the infant weight will be noted.
Effect variable:
Clinical:
Weight, height, BMI, abdominal circumference. Blood pressure (systolic, diastolic, mean arterial pressure). Weight of placenta, gestation length, Infant weight
Measurements in blood tests:
Se-creatinine, p-Na+, p-K+. P-plasminogen. P-albumin. P-renin concentration (not activity!), angiotensin II, aldosterone and arterial natriuretic peptide (ANP).
Measurements in 50 ml newly "spot urine":
Plasmin, plasminogen, ENaC peptide fragment (analyses in location of development), Proteolytic activity, Prostatin, Creatinine, Na+, K+.
If findings dictate it we may have to examine the following on chosen urine tests:
- The ability to activate ENaC- current in M-1-collecting duct cells by patch clamp electrophysiology on complete cells.
- Detection of different proteolytic forms of the ENaC gamma-subunit through antibody.
Measurements in 24- hour urine samples:
Na+/K+ - concentration. Creatinine clearance. Albumin.
Study process:
The three groups, "cases" (patients with preeclampsia) and "pregnant controls" (patients with normal pregnancies) and non pregnant controls ( non pregnant woman), are provided with 10 days of a healthy fully diet with a fixed low- normal NaCl content of 50 -60 mmol Na+/ day. The diet has the same content of calories per kg body weight and has the same content of potassium as far as possible. In this period of time the patients must only consume this diet and regularly drink water. Besides the fixed diet the patients are given a supplement with either sodium or placebo. The sequence is double randomized. The participants ingests either sodium tablets (150-200 mmol /day) or a corresponding number of placebo tablets. On the fifth day, the participants switch their daily supplement, so they now take placebo instead of sodium or the other way around.
Day number 1 is a Monday and day number 5 is a Friday where the measurements are to be done. 24-h urine samples are collected from Thursday 7 a.m. till Friday morning. On the 5th day the participants meet from 9 a.m. to 10 a.m. They are placed in a chair with elevated legs and relaxed for an hour in calm surroundings.
From 7 a.m. they ingest 200 ml water per hour. Spot urine tests are collected. Blood pressure is measured with an automatic oscillometric device. Intravenous access is made and blood samples are taken to decide the plasma hormone concentration (renin, angiotensin, aldosterone, ANP) and albumin, plasminogen and electrolytes. Cardiac output is measured non-invasive by impedance cardiography. Placenta flow is measured by ultrasound. The procedure lasts approximately 2 hours.
Hereafter a fixed, fully diet is given either with a sodium supply, a total of 250 mmol/day (corresponding to a high average sodium intake in Denmark) or placebo tablets. This diet is given in 4 days and measurements are made on the 5th day as described above.
A fixed sodium intake is given to:
- Get valid steady-state values for the RAAS- components;
- To study reactivity in RAAS components by changes in the NaCl intake
- Decide changes in blood pressure during 2 different normal NaCl intakes - low and high normal
- Correlate RAAS reactivity to urine excretion of plasmin/plasminogen under the hypothesis at the correlation will be conversely and
- Achieve valid values for aldosterone in correlation to the placenta flow. Length of gestation and placenta´s weight is registered at birth.
Data- analysis methods:
Introduction:
This is an interventional double blinded case-control, cross-over study which includes 10 patients with preeclampsia, 10 patients with normal pregnancies and 10 non pregnant woman.
Population size evaluation:
The settings for a Ph.D. study makes it impossible to accomplish a fixed sodium diet intervention in 10 days with the amount of patients required to get a relevant change in the blood pressure detection.
With a paired design it is estimated that to achieve an expected change in blood pressure at approximately 15 mmHg in the individual and a clinical relevant different in blood pressure at 8 mmHg the sample size must include 40 patients (5% percentage point - 90% strength). Therefore we have chosen that blood pressure is not the primary variable of the outcome, instead we choose the RAAS components.
In previously similar designs we have measured hypertensive vs. normotensive patients and had enough statistic strength to detect differences in plasma concentrations of renin-angiotensin-aldosterone components and ANP by using 10 patients in each group.
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Pregnancy
- Being tested
- Sodium, Placebo
- Keywords
- Proteinuria, Pregnancy, Hypertension, Plasmin, Plasminogen, Aldosterone, Angiotensin, Renin, sodium chloride, epithelial sodium channel, Placenta
- Medical subject headings
- Pre-Eclampsia, Hypertension, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SodiumDietary supplement
supplemental sodium tablets 150-200 mmol/day in 5 days
PlaceboDietary supplement
Placebo are given in 5 days
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia | Other | patients with preeclampsia are given a diet with a fixed content of sodium chloride ( 50-60 mmol/day ) plus a supplement of sodium chloride tablets ( 150-200 mmol/day) OR they are given placebo tablets.
After 5 days they switch their supplement. Receives: Dietary Supplement: Sodium; Dietary Supplement: Placebo |
| Controls | Other | Controls are given a diet with a fixed content of sodium chloride ( 50-60 mmol/day ) plus a supplement of sodium chloride tablets ( 150-200 mmol/day) OR they are given placebo tablets.
After 5 days they switch their supplement Receives: Dietary Supplement: Sodium; Dietary Supplement: Placebo |
| not-pregnant women | Other | This arm is also a control- group. Controls are given a diet with a fixed content of sodium chloride ( 50-60 mmol/day ) plus a supplement of sodium chloride tablets ( 150-200 mmol/day) OR they are given placebo tablets.
After 5 days they switch their supplement Receives: Dietary Supplement: Sodium; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine Plasmin/plasminogen correlation to the severity of preeclampsia
We suggest that the loss of plasmin/plasminogen are shared for the diseases with proteinuria, including PE, and that plasmin- driven ENaC activation is a causal factor in the pathophysiology of established PE. We believe that high concentrations of plasmin/plasminogen in the urine correlates to the severity og preeclampsia.
-Another outcome measure is the correlation between plasma aldosterone and the placental (under)development.
Measured: 3 years
Secondary outcomes (2)
correlation between RAAS components in urine and severity of preeclampsia
Measured: 3 years
Degree of aldosterone suppression in PE determines placental development
PE is characterized by low aldosterone levels and by an underdeveloped placenta. In established PE, suppression of aldosterone can possibly contribute to an underdeveloped placenta.
A causal link between the degree of aldosterone suppression and morphological placenta abnormalities is not yet established. We compare blood levels of aldosterone to flow in a. umbilicalis and a.uterine by ultrasound.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Lundbeck Foundation
- Responsible party
- Principal investigator, Lise Hald Nielsen, Odense University Hospital
- Investigators
- Boye L. Jensen, Professor, Study director, cardiovascular and renal research department, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828138
- Sponsor's protocol ID
- 9-5510
- Acronym
- HUPP
- Status last verified
- Oct 2015
- First submitted
- 5 Apr 2013
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUPP-study -Hypertension and Urine Protease Activity in Preeclampsia
- ClinicalTrials.gov ID
- NCT01828138
- Acronym / sponsor ID
- HUPP / 9-5510
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Pregnancy
- Keywords
- Proteinuria, Pregnancy, Hypertension, Plasmin, Plasminogen, Aldosterone, Angiotensin, Renin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Lundbeck Foundation
- Study start
- May 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Apr 2013 (estimated)
- 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.
Preeclampsia (PE) is a common disorder of pregnancy that complicates 4-7% of all pregnancies. It is a serious condition with acute proteinuria and hypertension and varying degrees of edema after 20 weeks of gestation. PE leads to a severe risk of low birth weight because of prematurity with inherent complications. The pathogenesis is unknown but is assumed to involve placental ischemia.The primary placental disorder results in renal glomerular injury. Established PE is associated with paradoxical suppression of the renin-angiotensin-aldosterone system, RAAS.
Despite suppressed RAAS, patients with PE retain NaCl(sodium chloride) after an intravenous isotonic NaCl overload compared to healthy pregnant women on a low NaCl diet. The investigators believe to have data that provide a possible explanation for the overall relationship between proteinuria, NaCl retension, suppression of RAAS, hypertension and underdevelopment of placenta. Earlier data, which the investigators have confirmed, shows abnormal glomerular loss of the enzyme plasmin/plasminogen from plasma to the urine in PE. Active plasmin in urine from patients with nephrotic syndrome and PE activates the epithelial sodium channel ( ENaC ) in renal collecting duct cells. The investigators hypothesize that loss of plasmin/plasminogen are shared for the diseases with proteinuria, including PE, and that plasmin- driven ENaC (epithelial sodium channel) activation is a causal factor in the pathophysiology of established PE. Hyperactive ENaC causes primary renal sodium retention with secondary suppression of the renin-angiotensin-aldosterone system. Aldosterone is recently established as a placental growth factor.
Plasma-aldosterone levels are significant higher in normal pregnant women. PE is characterized by low aldosterone levels (a discovery the investigators have also confirmed) and by placental underdevelopment.
Study Aim: To test specific hypothesis regarding established PE´s pathophysiological mechanisms.
Study Hypothesis:
- Excretion of urine proteases (plasmin/plasminogen) in PE leads to an activation of ENaC and hence RAAS is less NaCl sensitive while the blood pressure is more NaCl sensitive compared to healthy pregnant women.
- The degree of aldosterone suppression in PE determines placental development
Detailed description
Selection of patients:
The selection of patients is based on outpatients with preeclampsia and patients with normal pregnancies recruited from gynecological-obstetric department, Aarhus University Hospital - Skejby, Denmark. Non- pregnant woman are recruited by posting notices at the workplace. Specifically by office facilities, canteen and in gynecological department at Skejby hospital, Aarhus.
Background information:
Registration of date of birth, sex, weight, height, abdominal circumference, and smoking status will be noted.
Furthermore, we will register current antihypertensive-, diuretic-, antidiabetic- and antiepileptic medicine and other current use of medicine. Also post-partum registration of gestation length, placentas weight and the infant weight will be noted.
Effect variable:
Clinical:
Weight, height, BMI, abdominal circumference. Blood pressure (systolic, diastolic, mean arterial pressure). Weight of placenta, gestation length, Infant weight
Measurements in blood tests:
Se-creatinine, p-Na+, p-K+. P-plasminogen. P-albumin. P-renin concentration (not activity!), angiotensin II, aldosterone and arterial natriuretic peptide (ANP).
Measurements in 50 ml newly "spot urine":
Plasmin, plasminogen, ENaC peptide fragment (analyses in location of development), Proteolytic activity, Prostatin, Creatinine, Na+, K+.
If findings dictate it we may have to examine the following on chosen urine tests:
- The ability to activate ENaC- current in M-1-collecting duct cells by patch clamp electrophysiology on complete cells.
- Detection of different proteolytic forms of the ENaC gamma-subunit through antibody.
Measurements in 24- hour urine samples:
Na+/K+ - concentration. Creatinine clearance. Albumin.
Study process:
The three groups, "cases" (patients with preeclampsia) and "pregnant controls" (patients with normal pregnancies) and non pregnant controls ( non pregnant woman), are provided with 10 days of a healthy fully diet with a fixed low- normal NaCl content of 50 -60 mmol Na+/ day. The diet has the same content of calories per kg body weight and has the same content of potassium as far as possible. In this period of time the patients must only consume this diet and regularly drink water. Besides the fixed diet the patients are given a supplement with either sodium or placebo. The sequence is double randomized. The participants ingests either sodium tablets (150-200 mmol /day) or a corresponding number of placebo tablets. On the fifth day, the participants switch their daily supplement, so they now take placebo instead of sodium or the other way around.
Day number 1 is a Monday and day number 5 is a Friday where the measurements are to be done. 24-h urine samples are collected from Thursday 7 a.m. till Friday morning. On the 5th day the participants meet from 9 a.m. to 10 a.m. They are placed in a chair with elevated legs and relaxed for an hour in calm surroundings.
From 7 a.m. they ingest 200 ml water per hour. Spot urine tests are collected. Blood pressure is measured with an automatic oscillometric device. Intravenous access is made and blood samples are taken to decide the plasma hormone concentration (renin, angiotensin, aldosterone, ANP) and albumin, plasminogen and electrolytes. Cardiac output is measured non-invasive by impedance cardiography. Placenta flow is measured by ultrasound. The procedure lasts approximately 2 hours.
Hereafter a fixed, fully diet is given either with a sodium supply, a total of 250 mmol/day (corresponding to a high average sodium intake in Denmark) or placebo tablets. This diet is given in 4 days and measurements are made on the 5th day as described above.
A fixed sodium intake is given to:
- Get valid steady-state values for the RAAS- components;
- To study reactivity in RAAS components by changes in the NaCl intake
- Decide changes in blood pressure during 2 different normal NaCl intakes - low and high normal
- Correlate RAAS reactivity to urine excretion of plasmin/plasminogen under the hypothesis at the correlation will be conversely and
- Achieve valid values for aldosterone in correlation to the placenta flow. Length of gestation and placenta´s weight is registered at birth.
Data- analysis methods:
Introduction:
This is an interventional double blinded case-control, cross-over study which includes 10 patients with preeclampsia, 10 patients with normal pregnancies and 10 non pregnant woman.
Population size evaluation:
The settings for a Ph.D. study makes it impossible to accomplish a fixed sodium diet intervention in 10 days with the amount of patients required to get a relevant change in the blood pressure detection.
With a paired design it is estimated that to achieve an expected change in blood pressure at approximately 15 mmHg in the individual and a clinical relevant different in blood pressure at 8 mmHg the sample size must include 40 patients (5% percentage point - 90% strength). Therefore we have chosen that blood pressure is not the primary variable of the outcome, instead we choose the RAAS components.
In previously similar designs we have measured hypertensive vs. normotensive patients and had enough statistic strength to detect differences in plasma concentrations of renin-angiotensin-aldosterone components and ANP by using 10 patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia | Other | Dietary Supplement: Sodium, Dietary Supplement: Placebopatients with preeclampsia are given a diet with a fixed content of sodium chloride ( 50-60 mmol/day ) plus a supplement of sodium chloride tablets ( 150-200 mmol/day) OR they are given placebo tablets. After 5 days they switch their supplement. |
| Controls | Other | Dietary Supplement: Sodium, Dietary Supplement: PlaceboControls are given a diet with a fixed content of sodium chloride ( 50-60 mmol/day ) plus a supplement of sodium chloride tablets ( 150-200 mmol/day) OR they are given placebo tablets. After 5 days they switch their supplement |
| not-pregnant women | Other | Dietary Supplement: Sodium, Dietary Supplement: PlaceboThis arm is also a control- group. Controls are given a diet with a fixed content of sodium chloride ( 50-60 mmol/day ) plus a supplement of sodium chloride tablets ( 150-200 mmol/day) OR they are given placebo tablets. After 5 days they switch their supplement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Pregnancy week 28-36 (exclusion of patients with previously severe preeclampsia).
- Singleton pregnancy
- Preeclampsia- hypertension: repetitive high blood pressures (> 140/80 mm Hg) measured in the consultation and proteinuria (dip test, albumin).
- Pregnant with microalbuminuria and proteinuria, but without hypertension (and therefore do not meet the diagnostic criteria for preeclampsia) can also be included. Proteinuria is the most important factor.
- It is still possible to test our hypothesis with possible comorbidity such as diabetes, SLE(systemic lupus erythematosus), rheumatoid arthritis and therefore not a reason for exclusion.
Key exclusion criteria (12 listed)
- Hypertension in pregnancy without proteinuria.
- Pregestational nephropathy by other unknown reasons.
- Early severe preeclampsia.
- Organic or systemic disease of clinical relevance, such as malignancy.
- Pregnant controls-
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 |
|---|---|---|
| Sodiumsupplemental sodium tablets 150-200 mmol/day in 5 days | Dietary supplement | Controls, Preeclampsia, not-pregnant women |
| PlaceboPlacebo are given in 5 days | Dietary supplement | Controls, Preeclampsia, not-pregnant women |
Primary outcome
urine Plasmin/plasminogen correlation to the severity of preeclampsia
Time frame: 3 years
We suggest that the loss of plasmin/plasminogen are shared for the diseases with proteinuria, including PE, and that plasmin- driven ENaC activation is a causal factor in the pathophysiology of established PE. We believe that high concentrations of plasmin/plasminogen in the urine correlates to the severity og preeclampsia. -Another outcome measure is the correlation between plasma aldosterone and the placental (under)development.
2 secondary outcomes
correlation between RAAS components in urine and severity of preeclampsia
Time frame: 3 years
Degree of aldosterone suppression in PE determines placental development
Time frame: 3 years
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 16 Oct 2015.
- webpage of the research group and related projectsLink provided by the sponsor.
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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.
Boye L. Jensen, Professor study director
cardiovascular and renal research department, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium in people with Preeclampsia and Hypertension, run by Odense University Hospital at 1 site 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 10 inclusion and 12 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 16 Oct 2015. 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 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?
urine Plasmin/plasminogen correlation to the severity of preeclampsia (time frame: 3 years). 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 16 Oct 2015.