Heart FailurePhase 2NCT00555685
Hypertonic Saline Solution in Heart Failure
A Phase 2 study testing NaCl 7,5% (Hypertonic Saline Solution) and NaCl 0,9% in people with Heart Failure and Renal Failure, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Renal Failure, Hyponatremia
- What is being tested?
- NaCl 7,5% (Hypertonic Saline Solution) and NaCl 0,9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Dec 2010
- Phase
- Phase 2
- 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
- Age over 18 years old
- Heart failure according to Framingham criteria
- Episode of acute decompensation,with need of in-hospital treatment
- Presence of congestive phenomena
Who cannot join
- Patient denial
- Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
- Rheumatic disease
- Restrictive cardiomyopathy
- Alcohol abuse
- Chronic obstructive pulmonary disease
Show all 14Show fewer
- Cancer
- Pulmonary embolism during the last 6 months
- Surgical procedures or acute illness during the last 30 days
- Chronic or acute infection
- Any other circumstance that may hamper patient prognosis for the next 6 months
- Serum creatine over 3.0mg/dL
- Serum potassium over 5.5 mEqs/L
- Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute of São Paulo University Medical School
São Paulo, São Paulo, 05403-000
About this study
Official title: Hypertonic Saline Solution in Decompensated Heart Failure
Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.
- Conditions
- Heart Failure, Renal Failure, Hyponatremia
- Being tested
- NaCl 7,5% (Hypertonic Saline Solution), NaCl 0,9%
- Keywords
- Heart Failure, Renal failure, Hyponatremia
- Medical subject headings
- Heart Failure, Renal Insufficiency, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 7,5% (Hypertonic Saline Solution)Drug
Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
NaCl 0,9%Drug
Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Group of patients that will receive hypertonic saline solution (NaCl 7,5%) Receives: Drug: NaCl 7,5% (Hypertonic Saline Solution) |
| B | Placebo comparator | Group of patients that will receive placebo Receives: Drug: NaCl 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of renal disfunction
Measured: During hospital admission
Secondary outcomes (2)
Improvement of hyponatremia
Measured: During hospital admission
Improvement of congestive phenomena
Measured: During hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Edimar Alcides Bocchi, University of Sao Paulo
- Investigators
- Edimar A Bocchi, Professor, Principal investigator, Heart Failure (InCor) University of São Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555685
- Sponsor's protocol ID
- FAPESP 2007/04048-7
- Status last verified
- Jun 2014
- First submitted
- 8 Nov 2007
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rocha-e-Silva M, Poli de Figueiredo LF. Small volume hypertonic resuscitation of circulatory shock. Clinics (Sao Paulo). 2005 Apr;60(2):159-72. doi: 10.1590/s1807-59322005000200013. Epub 2005 Apr 26.
PubMed 15880253Licata G, Di Pasquale P, Parrinello G, Cardinale A, Scandurra A, Follone G, Argano C, Tuttolomondo A, Paterna S. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as bolus in refractory congestive heart failure: long-term effects. Am Heart J. 2003 Mar;145(3):459-66. doi: 10.1067/mhj.2003.166.
PubMed 12660669Issa VS, Bacal F, Mangini S, Carneiro RM, Azevedo CH, Chizzola PR, Ferreira SM, Bocchi EA. Hypertonic saline solution for renal failure prevention in patients with decompensated heart failure. Arq Bras Cardiol. 2007 Oct;89(4):251-5. doi: 10.1590/s0066-782x2007001600007. English, Portuguese.
PubMed 17992382Issa VS, Andrade L, Ayub-Ferreira SM, Bacal F, de Braganca AC, Guimaraes GV, Marcondes-Braga FG, Cruz FD, Chizzola PR, Conceicao-Souza GE, Velasco IT, Bocchi EA. Hypertonic saline solution for prevention of renal dysfunction in patients with decompensated heart failure. Int J Cardiol. 2013 Jul 15;167(1):34-40. doi: 10.1016/j.ijcard.2011.11.087. Epub 2012 Jan 12.
PubMed 22243938
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Saline Solution in Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT00555685
- Acronym / sponsor ID
- FAPESP 2007/04048-7
- Conditions
- Heart Failure, Renal Failure, Hyponatremia
- Keywords
- Heart Failure, Renal failure, Hyponatremia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Nov 2007 (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.
Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: NaCl 7,5% (Hypertonic Saline Solution)Group of patients that will receive hypertonic saline solution (NaCl 7,5%) |
| B | Placebo comparator | Drug: NaCl 0,9%Group of patients that will receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years old
- Heart failure according to Framingham criteria
- Episode of acute decompensation,with need of in-hospital treatment
- Presence of congestive phenomena
Key exclusion criteria (14 listed)
- Patient denial
- Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
- Rheumatic disease
- Restrictive cardiomyopathy
- Alcohol abuse
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 |
|---|---|---|
| NaCl 7,5% (Hypertonic Saline Solution)Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days | Drug | A |
| NaCl 0,9%Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days | Drug | B |
Primary outcome
Occurrence of renal disfunction
Time frame: During hospital admission
2 secondary outcomes
Improvement of hyponatremia
Time frame: During hospital admission
Improvement of congestive phenomena
Time frame: During hospital admission
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 10 Jun 2014.
- Background: PubMed 15880253Rocha-e-Silva M, Poli de Figueiredo LF. Small volume hypertonic resuscitation of circulatory shock. Clinics (Sao Paulo). 2005 Apr;60(2):159-72. doi: 10.1590/s1807-59322005000200013. Epub 2005 Apr 26.
- Background: PubMed 12660669Licata G, Di Pasquale P, Parrinello G, Cardinale A, Scandurra A, Follone G, Argano C, Tuttolomondo A, Paterna S. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as bolus in refractory congestive heart failure: long-term effects. Am Heart J. 2003 Mar;145(3):459-66. doi: 10.1067/mhj.2003.166.
- Results publication: PubMed 17992382Issa VS, Bacal F, Mangini S, Carneiro RM, Azevedo CH, Chizzola PR, Ferreira SM, Bocchi EA. Hypertonic saline solution for renal failure prevention in patients with decompensated heart failure. Arq Bras Cardiol. 2007 Oct;89(4):251-5. doi: 10.1590/s0066-782x2007001600007. English, Portuguese.
- Derived from this study: PubMed 22243938Issa VS, Andrade L, Ayub-Ferreira SM, Bacal F, de Braganca AC, Guimaraes GV, Marcondes-Braga FG, Cruz FD, Chizzola PR, Conceicao-Souza GE, Velasco IT, Bocchi EA. Hypertonic saline solution for prevention of renal dysfunction in patients with decompensated heart failure. Int J Cardiol. 2013 Jul 15;167(1):34-40. doi: 10.1016/j.ijcard.2011.11.087. Epub 2012 Jan 12.
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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.
Edimar A Bocchi, Professor principal investigator
Heart Failure (InCor) University of São Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NaCl 7,5% (Hypertonic Saline Solution) and NaCl 0,9% in people with Heart Failure and Renal Failure, run by University of Sao Paulo at 1 site in Brazil.
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 14 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 10 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 Brazil. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Occurrence of renal disfunction (time frame: During hospital admission). 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 NCT00555685, which also lists 4 linked publications.
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 10 Jun 2014; AzTrials last refreshed its copy on 2 Nov 2026.