Acute Heart FailureNCT01619540
Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure in Chronic Obstructive Pulmonary Disease Exacerbation
A study testing Valsalva maneuver in people with Acute Heart Failure and COPD Exacerbation, run by University of Monastir at 4 sites in Tunisia.
Trial summary
Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis . The investigators expect that Valsalva Maneuver (VM) could be useful in this issue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure, COPD Exacerbation
- What is being tested?
- Valsalva maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesTunisia
- Study dates
- May 2011to Jun 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- We included in this group, patients with a history (previous history) of COPD who consulted the emergency room for an exacerbation of COPD defined by a respiratory rate> 25c/min and a pH <7.35 and a PaCO2 >6 KPa.
- This group is also divided into two groups according to clinical expert assessment and the BNP value: Group1 : BNP> 400pg/ml, Group2 : BNP <400PG / ml
Who cannot join
- We excluded from this study patients with Prominent cardiac arrest
- Rhythm disorders including severe tachycardia arrhythmia
- Auricular fibrillation
- Hemodynamic instability requiring the use of vasoactive drugs and a contre indications of non invasive ventilation such us consciousness disorders with a Glasgow score <12/15,a swallowing disorder
- A significant bronchial obstruction ,the upper airway obstruction , in upper gastrointestinal bleeding in progress, an extreme obesity and Cirrhosis or cancer.
- We are also excluded patients who did not cooperate and those who refused the study.
Trial locations and contacts
4 sites in 1 country.
Tunisia4 sites
Fattouma Bourguiba University hospital
Monastir, Monastir Governorate, 5000
University hospital of Moastir
Monastir, Monastir Governorate, 5000
University hospital of Monastir
Monastir, Monastir Governorate, 5000
University Hospital of Monastir
Monastir, Monstir, 5000
About this study
Official title: Study of the Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
This association is frequently underestimated with regard to the difficulty of clinical diagnosis .
The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.
- Conditions
- Acute Heart Failure, COPD Exacerbation
- Being tested
- Valsalva maneuver
- Keywords
- COPD, Left Ventricular Failure, Valsalva Manoeuver
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva maneuverOther
| Study group | Role | What they receive |
|---|---|---|
| acute heart failure | Other | control arm Receives: Other: Valsalva maneuver |
| COPD exacerbation | Experimental | COPD exacerbation Receives: Other: Valsalva maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular dysfunction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouira, University of Monastir
- Investigators
- Nouira Semir, Professor, Principal investigator, Monastir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619540
- Sponsor's protocol ID
- Valsalva
- Status last verified
- Sep 2013
- First submitted
- 12 Jun 2012
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boubaker H, Grissa MH, Debbabi H, Beltaief K, Dridi Z, Najjar MF, Bouida W, Boukef R, Marghli S, Nouira S. Value of Plethysmographic Pulse Amplitude Ratio With Valsalva Maneuver in Identifying Left Ventricular Dysfunction During COPD Exacerbation. Respir Care. 2016 Apr;61(4):439-46. doi: 10.4187/respcare.04091. Epub 2015 Dec 8.
PubMed 26647450
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01619540
- Acronym / sponsor ID
- Valsalva
- Conditions
- Acute Heart Failure, COPD Exacerbation
- Keywords
- COPD, Left Ventricular Failure, Valsalva Manoeuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jun 2012 (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.
Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
This association is frequently underestimated with regard to the difficulty of clinical diagnosis .
The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute heart failure | Other | Other: Valsalva maneuvercontrol arm |
| COPD exacerbation | Experimental | Other: Valsalva maneuverCOPD exacerbation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- We included in this group, patients with a history (previous history) of COPD who consulted the emergency room for an exacerbation of COPD defined by a respiratory rate> 25c/min and a pH <7.35 and a PaCO2 >6 KPa.
- This group is also divided into two groups according to clinical expert assessment and the BNP value: Group1 : BNP> 400pg/ml, Group2 : BNP <400PG / ml
Key exclusion criteria (6 listed)
- We excluded from this study patients with Prominent cardiac arrest
- Rhythm disorders including severe tachycardia arrhythmia
- Auricular fibrillation
- Hemodynamic instability requiring the use of vasoactive drugs and a contre indications of non invasive ventilation such us consciousness disorders with a Glasgow score <12/15,a swallowing disorder
- A significant bronchial obstruction ,the upper airway obstruction , in upper gastrointestinal bleeding in progress, an extreme obesity and Cirrhosis or cancer.
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 |
|---|---|---|
| Valsalva maneuver | Other | COPD exacerbation, acute heart failure |
Primary outcome
left ventricular dysfunction
Time frame: 24 hours
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 24 Sep 2013.
- Derived from this study: PubMed 26647450Boubaker H, Grissa MH, Debbabi H, Beltaief K, Dridi Z, Najjar MF, Bouida W, Boukef R, Marghli S, Nouira S. Value of Plethysmographic Pulse Amplitude Ratio With Valsalva Maneuver in Identifying Left Ventricular Dysfunction During COPD Exacerbation. Respir Care. 2016 Apr;61(4):439-46. doi: 10.4187/respcare.04091. Epub 2015 Dec 8.
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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.
Nouira Semir, Professor principal investigator
Monastir University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valsalva maneuver in people with Acute Heart Failure and COPD Exacerbation, run by University of Monastir at 4 sites in Tunisia.
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 2 inclusion and 6 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 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Tunisia. 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?
left ventricular dysfunction (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01619540, which also lists 1 linked publication.
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 24 Sep 2013.