Heart FailurePhase 3NCT01559727
Dose-comparison Study of Prednisone in Heart Failure
A Phase 3 study testing prednisone in people with Heart Failure, run by Hebei Medical University at 2 sites in China.
Trial summary
The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure. 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?
- prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2012to Mar 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized for symptomatic heart failure
- dyspnea at rest or with minimal activity
- NT-proBNP > 1000pg/ml
- LVEF ≤ 40%
Who cannot join
- any condition (other than CHF) that could limit the use of prednisone;
- acute decompensated heart failure
- active myocarditis
- obstructive or restrictive cardiomyopathy
- cardiac surgery within previous 3 months
- acute coronary syndrome
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
About this study
Official title: Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.
Read the detailed description
Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.
- Conditions
- Heart Failure
- Being tested
- prednisone
- Keywords
- heart failure, diuresis, prednisone
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
prednisoneDrug
The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day
prednisoneDrug
The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The patients with symptomatic heart failure were treated with standard treatment. |
| 15 mg prednisone group | Experimental | The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day. Receives: Drug: prednisone |
| 30 mg prednisone group | Experimental | The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day. Receives: Drug: prednisone |
| 60 mg prednisone group | Experimental | The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day. Receives: Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily urinary volumes
Daily urinary volumes will be monitored for 10 days.
Measured: 10 days
Urinary sodium excretion
Daily sodium exretions will be assessed at baseline, day 5 and day 10.
Measured: 10 days
Secondary outcomes (1)
The effect of prednisone on renin angiotensin aldosterone system.
The effect of prednisone on patients' renin angiotensin aldosterone system, such as renin activity, plasma Ang I, plasma Ang II, and plasma aldosterone will be will be assessed on baseline, day 5 and day 10.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionMar 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 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-shen Liu M.D., Hebei Medical University
- Investigators
- Kunshen Liu, MD, Principal investigator, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559727
- Sponsor's protocol ID
- GL-2011-29
- Status last verified
- Aug 2013
- First submitted
- 19 Mar 2012
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu C, Zhao Q, Zhen Y, Zhai J, Liu G, Zheng M, Ma G, Wang L, Tian L, Ji L, Li L, Duan L, Liu K. Effect of Corticosteroid on Renal Water and Sodium Excretion in Symptomatic Heart Failure: Prednisone for Renal Function Improvement Evaluation Study. J Cardiovasc Pharmacol. 2015 Sep;66(3):316-22. doi: 10.1097/FJC.0000000000000282.
PubMed 25992918
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
- ClinicalTrials.gov ID
- NCT01559727
- Acronym / sponsor ID
- GL-2011-29
- Conditions
- Heart Failure
- Keywords
- heart failure, diuresis, prednisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Mar 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.
The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.
Detailed description
Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The patients with symptomatic heart failure were treated with standard treatment. |
| 15 mg prednisone group | Experimental | Drug: prednisoneThe patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day. |
| 30 mg prednisone group | Experimental | Drug: prednisoneThe patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day. |
| 60 mg prednisone group | Experimental | Drug: prednisoneThe patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hospitalized for symptomatic heart failure
- dyspnea at rest or with minimal activity
- NT-proBNP > 1000pg/ml
- LVEF ≤ 40%
Key exclusion criteria (6 listed)
- any condition (other than CHF) that could limit the use of prednisone;
- acute decompensated heart failure
- active myocarditis
- obstructive or restrictive cardiomyopathy
- cardiac surgery within previous 3 months
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 |
|---|---|---|
| prednisoneThe patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day. | Drug | 15 mg prednisone group |
| prednisoneThe patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day | Drug | 30 mg prednisone group |
| prednisoneThe patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day | Drug | 60 mg prednisone group |
Primary outcome
Daily urinary volumes
Time frame: 10 days
Daily urinary volumes will be monitored for 10 days.
Urinary sodium excretion
Time frame: 10 days
Daily sodium exretions will be assessed at baseline, day 5 and day 10.
1 secondary outcome
The effect of prednisone on renin angiotensin aldosterone system.
Time frame: 10 days
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 28 Aug 2013.
- Derived from this study: PubMed 25992918Liu C, Zhao Q, Zhen Y, Zhai J, Liu G, Zheng M, Ma G, Wang L, Tian L, Ji L, Li L, Duan L, Liu K. Effect of Corticosteroid on Renal Water and Sodium Excretion in Symptomatic Heart Failure: Prednisone for Renal Function Improvement Evaluation Study. J Cardiovasc Pharmacol. 2015 Sep;66(3):316-22. doi: 10.1097/FJC.0000000000000282.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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.
Kunshen Liu, MD principal investigator
The First Hospital of Hebei Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prednisone in people with Heart Failure, run by Hebei Medical University at 2 sites in China.
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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 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?
Daily urinary volumes (time frame: 10 days). The study lists 2 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 NCT01559727, 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 28 Aug 2013.