Blood PressurePhase 4NCT03806582
Effect of a Higher Blood-pressure on Right Ventricular Function
A Phase 4 study testing Norepinephrine in people with Blood Pressure and Right Ventricular Dysfunction, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to have a positive influence on the right ventricular function in several animal studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Right Ventricular Dysfunction
- What is being tested?
- Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2019to 25 May 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post operative cardiac surgery patients, full sternotomy
- admission at ICU
- informed consent
- right ventricular monitoring by pulmonary artery catheter.
- RVEF <30% + MAP ≤ 65mmHg
Who cannot join
- no informed consent
- acute surgery
- Off pump cardiac surgery
- Severe tricuspid insufficiency
- Allergy to norepinephrine
- Severe left ventricular hypertrophy with systolic anterior movement
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- Chronic use of alpha-blockers
- Irregulair heart rhythm
- Surgical reasons to maintain a low blood pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to have a positive influence on the right ventricular function in several animal studies. The current study is designed to evaluate the effect of a higher blood pressure on the RV function in post cardiac surgery patients.
Read the detailed description
Goal: To demonstrate differences in RV function by raising the systemic blood pressure with norepinephrine.
Study design: randomized controlled trial Study population: 78 postoperative cardiac surgery patients admitted at the ICU.
Intervention:
- Group 1: (N=22): RVEF<20% and MAP≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.
- Group 2: (N=22): RVEF <20% and MAP≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.
- Group 3: (N=17): RVEF between ≥20 and <30% and MAP ≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.
- Group 4: (N=17): RVEF between ≥20 and <30% and MAP ≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.
Endpoints: Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF. Secondary endpoints are the echocardiographic parameters of RV and LV contractility, RV end-diastolic pressure, cardiac index, and fluid balance.
- Conditions
- Blood Pressure, Right Ventricular Dysfunction
- Being tested
- Norepinephrine
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
intervention with norepinephrine to reach a MAP of 85 mmHg
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | intervention with norepinephrine to reach a MAP of 85 mmHg for a maximum duration of 1 hour, observation of the effect on right ventricular function Receives: Drug: Norepinephrine |
| control | No intervention | control group; treatment according to current standards, observation of the effect on right ventricular function |
What is being measured
The primary outcome is the main question the study is designed to answer.
right ventricular ejection fraction
Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF.
Measured: 2 hours postoperative
Secondary outcomes (4)
Echocardiographic
Echocardiographic parameters of RV and LV contractility
Measured: 2 hours postoperative
RV end-diastolic pressure
RV end-diastolic pressure pre and post intervention
Measured: baseline and 15 minutes postoperatively
Cardiac index
Difference in cardiac index between intervention and control groups
Measured: 2 hours postoperative
Fluid balance
Difference in fluid balance between intervention and control groups
Measured: 2 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Mar 2019
- Primary completion15 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.C. Boerma, Frisius Medisch Centrum
- Investigators
- Christiaan Boerma, Dr, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806582
- Sponsor's protocol ID
- TPO 1051
- Status last verified
- May 2020
- First submitted
- 29 Oct 2018
- Last updated
- 27 May 2020
- 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 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Higher Blood-pressure on Right Ventricular Function
- ClinicalTrials.gov ID
- NCT03806582
- Acronym / sponsor ID
- TPO 1051
- Conditions
- Blood Pressure, Right Ventricular Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 16 Jan 2019 (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.
Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to have a positive influence on the right ventricular function in several animal studies. The current study is designed to evaluate the effect of a higher blood pressure on the RV function in post cardiac surgery patients.
Detailed description
Goal: To demonstrate differences in RV function by raising the systemic blood pressure with norepinephrine.
Study design: randomized controlled trial Study population: 78 postoperative cardiac surgery patients admitted at the ICU.
Intervention:
- Group 1: (N=22): RVEF<20% and MAP≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.
- Group 2: (N=22): RVEF <20% and MAP≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.
- Group 3: (N=17): RVEF between ≥20 and <30% and MAP ≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours.
- Group 4: (N=17): RVEF between ≥20 and <30% and MAP ≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.
Endpoints: Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF. Secondary endpoints are the echocardiographic parameters of RV and LV contractility, RV end-diastolic pressure, cardiac index, and fluid balance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Drug: Norepinephrineintervention with norepinephrine to reach a MAP of 85 mmHg for a maximum duration of 1 hour, observation of the effect on right ventricular function |
| control | No intervention | –control group; treatment according to current standards, observation of the effect on right ventricular function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- post operative cardiac surgery patients, full sternotomy
- admission at ICU
- informed consent
- right ventricular monitoring by pulmonary artery catheter.
- RVEF <30% + MAP ≤ 65mmHg
Key exclusion criteria (9 listed)
- no informed consent
- acute surgery
- Off pump cardiac surgery
- Severe tricuspid insufficiency
- Allergy to norepinephrine
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 |
|---|---|---|
| Norepinephrineintervention with norepinephrine to reach a MAP of 85 mmHg | Drug | intervention |
Primary outcome
right ventricular ejection fraction
Time frame: 2 hours postoperative
Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF.
4 secondary outcomes
Echocardiographic
Time frame: 2 hours postoperative
RV end-diastolic pressure
Time frame: baseline and 15 minutes postoperatively
Cardiac index
Time frame: 2 hours postoperative
Fluid balance
Time frame: 2 hours postoperative
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 27 May 2020.
- Individual participant dataSharing planned: No
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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.
Christiaan Boerma, Dr principal investigator
Frisius Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine in people with Blood Pressure and Right Ventricular Dysfunction, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 9 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 27 May 2020. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
right ventricular ejection fraction (time frame: 2 hours postoperative). 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 27 May 2020.