Lung CancerPhase 3PRESAGENCT01281787
PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer
A Phase 3 study testing Metoprolol and Losartan in people with Lung Cancer and Atrial Fibrillation, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide (NT-proBNP), measured in the perioperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Atrial Fibrillation
- What is being tested?
- Metoprolol and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2008to Oct 2013
- Phase
- Phase 3
- 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
- Patients of both sexes with age ≥ 18 years
- Thoracic surgery for lung cancer
- Evidence of elevated perioperative NT-proBNP
- Written informed consent
Who cannot join
- Hypersensitivity and / or intolerance to metoprolol or losartan
- History of heart failure
- Left ventricular ejection fraction <50% measured by echocardiographic techniques (Simpson rule)
- Permanent atrial fibrillation
- Antiarrhythmic therapy
- Current therapy with beta-blockers, angiotensin II receptor blockers and angiotensin-converting enzyme inhibitors
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- Systolic blood pressure <95 mmHg
- Pregnant and lactating women
- Additional exclusion criteria for therapy with beta-blocker:
- History of sick sinus syndrome, evidence of AV-block grade II or greater
- Heart rate <65 b / m
- History of bronchial asthma, severe bronchopneumopathy, evidence of bronchospasm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide (NT-proBNP), measured in the perioperative period.
Read the detailed description
Postoperative atrial fibrillation is one of the most common complication after thoracic surgery for lung cancer, with an incidence ranging from 8 to 20% after lobectomy and up to 42% after pneumonectomy.
In a recent study we demonstrated that a high perioperative plasma levels of NT-proBNP is able to identify patients at risk for AF (incidence of 65%).
It has also been demonstrated that the renin-angiotensin system may play an important role in the pathophysiology of atrial fibrillation and that angiotensin converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARBs) are able to prevent atrial fibrillation in patients with heart failure, after myocardial infarction, in hypertensive patients and after electrical cardioversion.
- Conditions
- Lung Cancer, Atrial Fibrillation
- Being tested
- Metoprolol, Losartan
- Keywords
- FAP= post-surgery atrial fibrillation, ACEI= angiotensin converting enzyme-inhibitors, ARBs= angiotensin II receptor blockers, NT-proBNP= brain natriuretic peptide
- Medical subject headings
- Lung Neoplasms, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Also called SELOKEN, LOPRESOR
Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
LosartanDrug
Also called LORTAAN, NEOLOTAN, LOSAPREX
Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Active comparator | angiotensin II-receptor blocker Receives: Drug: Losartan |
| no treatment | No intervention | no preventive treatment |
| Metoprolol | Active comparator | beta-adrenergic antagonist Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative atrial fibrillation
Measured: up to 10 days
Secondary outcomes (1)
Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startApr 2008
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Cardinale, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281787
- Sponsor's protocol ID
- IEO S365/407
- Other IDs
- 2007-003856-12
- Acronym
- PRESAGE
- Status last verified
- Jun 2014
- First submitted
- 21 Dec 2010
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
- ClinicalTrials.gov ID
- NCT01281787
- Acronym / sponsor ID
- PRESAGE / IEO S365/407
- Conditions
- Lung Cancer, Atrial Fibrillation
- Keywords
- FAP= post-surgery atrial fibrillation, ACEI= angiotensin converting enzyme-inhibitors, ARBs= angiotensin II receptor blockers, NT-proBNP= brain natriuretic peptide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Jan 2011 (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.
The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide (NT-proBNP), measured in the perioperative period.
Detailed description
Postoperative atrial fibrillation is one of the most common complication after thoracic surgery for lung cancer, with an incidence ranging from 8 to 20% after lobectomy and up to 42% after pneumonectomy.
In a recent study we demonstrated that a high perioperative plasma levels of NT-proBNP is able to identify patients at risk for AF (incidence of 65%).
It has also been demonstrated that the renin-angiotensin system may play an important role in the pathophysiology of atrial fibrillation and that angiotensin converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARBs) are able to prevent atrial fibrillation in patients with heart failure, after myocardial infarction, in hypertensive patients and after electrical cardioversion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Losartan | Active comparator | Drug: Losartanangiotensin II-receptor blocker |
| no treatment | No intervention | –no preventive treatment |
| Metoprolol | Active comparator | Drug: Metoprololbeta-adrenergic antagonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes with age ≥ 18 years
- Thoracic surgery for lung cancer
- Evidence of elevated perioperative NT-proBNP
- Written informed consent
Key exclusion criteria (12 listed)
- Hypersensitivity and / or intolerance to metoprolol or losartan
- History of heart failure
- Left ventricular ejection fraction <50% measured by echocardiographic techniques (Simpson rule)
- Permanent atrial fibrillation
- Antiarrhythmic therapy
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 |
|---|---|---|
| MetoprololAlso: SELOKEN, LOPRESORMetoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay | Drug | Metoprolol |
| LosartanAlso: LORTAAN, NEOLOTAN, LOSAPREXLosartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay | Drug | Losartan |
Primary outcome
Incidence of postoperative atrial fibrillation
Time frame: up to 10 days
1 secondary outcome
Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay
Time frame: up to 10 days
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 18 Jun 2014.
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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.
Daniela Cardinale, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metoprolol and Losartan in people with Lung Cancer and Atrial Fibrillation, run by European Institute of Oncology at 1 site in Italy.
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 4 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 18 Jun 2014. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of postoperative atrial fibrillation (time frame: up to 10 days). 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 18 Jun 2014.