Acute Heart FailureNCT01127945
Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
A study testing statin in people with Acute Heart Failure, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Nov 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dyspnea at rest or minimal activity
- Tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
Who cannot join
- Acute coronary Syndrome
- Hospitalization plan for PTCA or CABG
- Cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- Uncontrolled hypertension (Systolic Blood Pressure > 180mmHg)
- Allergy, adverse drug reaction, hypersensitivity to statin
- Troponin > 5 times upper limit of normal (ULN)
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- Creatinine kinase-MB level > 3 times ULN
- AST, ALT > 3 times ULN or acute hepatitis
- Current or past history of muscle disease, rhabdomyolysis
- Life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis)
- Pregnancy or women at age of childbearing potential
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular hospital, Yonsei University College of Medicine
Seoul
About this study
Official title: A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients.
- Conditions
- Acute Heart Failure
- Being tested
- statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statinDrug
- adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy
- acute heart failure therapy
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin 80mg | Experimental | Not described Receives: Drug: statin |
| conventional therapy (for heart failure) | Active comparator | Not described Receives: Drug: statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP levels
to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure
Measured: at hospital day #4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok-Min Kang, Study director, Severance Cardiovascular hospital, Yonsei University College of MedicineHui-Nam Pak, Principal investigator, Severance Cardiovascular hospital, Yonsei University College of MedicineBoyoung Joung, Principal investigator, Severance Cardiovascular hospital, Yonsei University College of MedicineSungha Park, Principal investigator, Severance Cardiovascular hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127945
- Sponsor's protocol ID
- 4-2010-0014
- Status last verified
- Feb 2014
- First submitted
- 18 May 2010
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01127945
- Acronym / sponsor ID
- 4-2010-0014
- Conditions
- Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 May 2010 (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.
This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin 80mg | Experimental | Drug: statin |
| conventional therapy (for heart failure) | Active comparator | Drug: statin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dyspnea at rest or minimal activity
- Tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
Key exclusion criteria (11 listed)
- Acute coronary Syndrome
- Hospitalization plan for PTCA or CABG
- Cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- Uncontrolled hypertension (Systolic Blood Pressure > 180mmHg)
- Allergy, adverse drug reaction, hypersensitivity to statin
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 |
|---|---|---|
| statin1. adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy 2. acute heart failure therapy | Drug | atorvastatin 80mg, conventional therapy (for heart failure) |
Primary outcome
hsCRP levels
Time frame: at hospital day #4
to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure
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 5 Feb 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.
Seok-Min Kang study director
Severance Cardiovascular hospital, Yonsei University College of Medicine
Hui-Nam Pak principal investigator
Severance Cardiovascular hospital, Yonsei University College of Medicine
Boyoung Joung principal investigator
Severance Cardiovascular hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing statin in people with Acute Heart Failure, run by Yonsei University at 1 site in South Korea.
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 11 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 5 Feb 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 South Korea. 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?
hsCRP levels (time frame: at hospital day #4). 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 5 Feb 2014.