Heart FailurePhase 4NCT03255044
Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure
A Phase 4 study testing Atorvastatin, Rosuvastatin and guideline directed therapy in people with Heart Failure, run by Ain Shams University at 1 site in Egypt.
Trial summary
There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Atorvastatin, Rosuvastatin and guideline directed therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2017to 1 Apr 2019
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years (of both sexes)
- diagnosed with stable chronic heart failure NYHA class II-III
- ejection fraction < 40 % as assessed by 2D echocardiography
- who have been optimized on Guideline Directed treatment for heart failure for at least a month prior to enrolling.
Who cannot join
- Known hypersensitivity to statin
- Treatment with statins during the past month prior to study.
- Serum creatinine > 3 mg/dl
- Significant liver disease: liver enzymes 2.5 folds the upper normal limit
- Malignancy
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure
There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. This trial is designed to compare the effects of lipophilic versus hydrophilic statin use in patients with heart failure.
- Conditions
- Heart Failure
- Being tested
- Atorvastatin, Rosuvastatin, guideline directed therapy
- Keywords
- statin, hydrophilic, lipophilic
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called standard heart failure therapy
Atorvastatin administered as well as standard heart failure therapy
RosuvastatinDrug
Also called standard heart failure therapy
Rosuvastatin administered as well as standard heart failure therapy
guideline directed therapyOther
standard heart failure therapy
| Study group | Role | What they receive |
|---|---|---|
| Lipophilic statin | Active comparator | Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure. Receives: Drug: Atorvastatin; Other: guideline directed therapy |
| Hydrophilic statin | Active comparator | Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure. Receives: Drug: Rosuvastatin; Other: guideline directed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF)
Measured: 6 months
Left Ventricular End-diastolic volume (LVEDV)
Measured: 6 months
Left Ventricular End-systolic volume (LVESV)
Measured: 6 months
cardiac markers
NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)
Measured: 6 months
Secondary outcomes (2)
Minnesota Living with Heart Failure Questionnaire( MLHFQ)
Measured: 6 months
Packer composite outcome
- Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment: markedly/moderately improved (or both) but did not experience any major adverse clinical events during the course of the trial (death or hospitalization).
- Patients are considered worse if they experienced a major clinical event during the duration of treatment or reported worsening of their NYHA class or global assessment at the final visit.
- Patients are considered unchanged if they are neither improved nor worse.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Jun 2017
- Primary completion1 Mar 2019
- Study completion1 Apr 2019
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Omar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255044
- Sponsor's protocol ID
- 48
- Status last verified
- Jan 2020
- First submitted
- 10 Aug 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Said NO, El Wakeel LM, Khorshid H, Darweesh EAG, Ahmed MA. Impact of lipophilic vs hydrophilic statins on the clinical outcome and biomarkers of remodelling in heart failure patients: A prospective comparative randomized study. Br J Clin Pharmacol. 2021 Jul;87(7):2855-2866. doi: 10.1111/bcp.14695. Epub 2021 Jan 3.
PubMed 33294980
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03255044
- Acronym / sponsor ID
- 48
- Conditions
- Heart Failure
- Keywords
- statin, hydrophilic, lipophilic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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.
There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. This trial is designed to compare the effects of lipophilic versus hydrophilic statin use in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipophilic statin | Active comparator | Drug: Atorvastatin, Other: guideline directed therapyAtorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure. |
| Hydrophilic statin | Active comparator | Drug: Rosuvastatin, Other: guideline directed therapyRosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than 18 years (of both sexes)
- diagnosed with stable chronic heart failure NYHA class II-III
- ejection fraction < 40 % as assessed by 2D echocardiography
- who have been optimized on Guideline Directed treatment for heart failure for at least a month prior to enrolling.
Key exclusion criteria (6 listed)
- Known hypersensitivity to statin
- Treatment with statins during the past month prior to study.
- Serum creatinine > 3 mg/dl
- Significant liver disease: liver enzymes 2.5 folds the upper normal limit
- Malignancy
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 |
|---|---|---|
| AtorvastatinAlso: standard heart failure therapyAtorvastatin administered as well as standard heart failure therapy | Drug | Lipophilic statin |
| RosuvastatinAlso: standard heart failure therapyRosuvastatin administered as well as standard heart failure therapy | Drug | Hydrophilic statin |
| guideline directed therapystandard heart failure therapy | Other | Hydrophilic statin, Lipophilic statin |
Primary outcome
Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Left Ventricular End-diastolic volume (LVEDV)
Time frame: 6 months
Left Ventricular End-systolic volume (LVESV)
Time frame: 6 months
cardiac markers
Time frame: 6 months
NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)
2 secondary outcomes
Minnesota Living with Heart Failure Questionnaire( MLHFQ)
Time frame: 6 months
Packer composite outcome
Time frame: 6 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 9 Jan 2020.
- Derived from this study: PubMed 33294980El Said NO, El Wakeel LM, Khorshid H, Darweesh EAG, Ahmed MA. Impact of lipophilic vs hydrophilic statins on the clinical outcome and biomarkers of remodelling in heart failure patients: A prospective comparative randomized study. Br J Clin Pharmacol. 2021 Jul;87(7):2855-2866. doi: 10.1111/bcp.14695. Epub 2021 Jan 3.
- Individual participant dataSharing planned: No
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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 4 study testing Atorvastatin, Rosuvastatin and guideline directed therapy in people with Heart Failure, run by Ain Shams University at 1 site in Egypt.
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 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 9 Jan 2020. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Left Ventricular Ejection Fraction (LVEF) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT03255044, 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 9 Jan 2020.