Heart FailurePhase 3PROTEICANCT02708771
Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
A Phase 3 study testing Polyunsaturated fatty acids omega-3 in people with Heart Failure, run by Hospital San Juan de la Cruz at 1 site in Spain.
Trial summary
Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Polyunsaturated fatty acids omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2016to Jun 2018
- 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 aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (CRP ?2,5 mg / dl).
Who cannot join
- Impending doom
- Participating in other clinical trials
- Treatment with ?-3 acids in the last month prior to admission
- Percutaneous or surgical treatment of the cause of heart failure during hospitalization.
- Pregnant women.
- Renal failure on dialysis.
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- Chronic liver disease Child-Pugh B or C.
- Acute infectious process.
- Active malignant neoplasia.
Trial locations and contacts
1 site in 1 country.
About this study
Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin
Read the detailed description
Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin
Assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on:
- Inflammatory activity (C-reactive protein)
- The development of biomarkers (NTproBNP).
- The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.
- Conditions
- Heart Failure
- Being tested
- Polyunsaturated fatty acids omega-3, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyunsaturated fatty acids omega-3Drug
4 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester.
PlaceboDrug
Also called Control
4 daily capsules of similar appearance and flavor without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 4 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester. Receives: Drug: Polyunsaturated fatty acids omega-3 |
| Control | Placebo comparator | Capsules of similar appearance and flavor without active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum albumin levels
Serum albumin levels in the fourth week
Measured: Four weeks
Secondary outcomes (3)
C-reactive protein levels
C-reactive protein levels in the fourth week
Measured: Four weeks
NTproBNP levels
NTproBNP levels in the fourth week
Measured: Four weeks
Combined event of death from any cause or readmission for heart failure
Combined event of death from any cause or readmission for heart failure within three months after randomization
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Juan de la Cruz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708771
- Sponsor's protocol ID
- HSJC-CAR-01-2015
- Acronym
- PROTEICA
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2016
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
- ClinicalTrials.gov ID
- NCT02708771
- Acronym / sponsor ID
- PROTEICA / HSJC-CAR-01-2015
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospital San Juan de la CruzUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Mar 2016 (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.
Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin
Detailed description
Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin
Assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on:
- Inflammatory activity (C-reactive protein)
- The development of biomarkers (NTproBNP).
- The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Polyunsaturated fatty acids omega-34 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester. |
| Control | Placebo comparator | Drug: PlaceboCapsules of similar appearance and flavor without active drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (CRP ?2,5 mg / dl).
Key exclusion criteria (9 listed)
- Impending doom
- Participating in other clinical trials
- Treatment with ?-3 acids in the last month prior to admission
- Percutaneous or surgical treatment of the cause of heart failure during hospitalization.
- Pregnant women.
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 |
|---|---|---|
| Polyunsaturated fatty acids omega-34 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester. | Drug | Intervention |
| PlaceboAlso: Control4 daily capsules of similar appearance and flavor without active ingredient | Drug | Control |
Primary outcome
Serum albumin levels
Time frame: Four weeks
Serum albumin levels in the fourth week
3 secondary outcomes
C-reactive protein levels
Time frame: Four weeks
NTproBNP levels
Time frame: Four weeks
Combined event of death from any cause or readmission for heart failure
Time frame: Three months
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 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polyunsaturated fatty acids omega-3 in people with Heart Failure, run by Hospital San Juan de la Cruz at 1 site in Spain.
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 1 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 10 Feb 2021. 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 Spain. 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 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?
Serum albumin levels (time frame: Four weeks). 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 10 Feb 2021.