Heart Failure, CongestivePhase 2/3NCT00369044
Prednisone for Decompensated Congestive Heart Failure
A Phase 2/3 study testing prednisone in people with Heart Failure, Congestive, run by Hebei Medical University at 1 site in China.
Trial summary
We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- prednisone
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2006to Jul 2008
- Phase
- Phase 2/3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with primary diagnosis of CHF
- Patients with normal cortical function
- LVEF <40%
- Significant fluid overload, defined as ≥ 2 of the following
- Enlarged liver or ascites
- Peripheral or sacral edema ( ≥ 2+)
- Jugular venous distention ≥ 10 cm
- Pulmonary rales, pleural effusion on chest x-ray or orthopnea
Who cannot join
- Severe stenotic valvular disease
- Serum creatinine > 4 mg/dl
- Patient refusal
- Any signs of infection or any condition that would contraindicate an glucocorticoids use
- Poor controlled hypertension
- Poor controlled diabetes mellitus
- Active myocarditis
- Malignancy or other terminal illness
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
About this study
Official title: Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure
We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.
Read the detailed description
Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.
- Conditions
- Heart Failure, Congestive
- Being tested
- prednisone
- Keywords
- decompensated heart failure, prednisone, diuretics, diuresis
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2
Secondary outcomes (1)
Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startOct 2006
- Study completionJul 2008 (estimated)
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 Failure, CongestiveStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Kunshen Liu, MD, Principal investigator, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369044
- Sponsor's protocol ID
- 200608A
- Status last verified
- Jun 2007
- First submitted
- 28 Aug 2006
- Last updated
- 8 Apr 2009
- Results posted
- No
Publications
Liu C, Chen H, Zhou C, Ji Z, Liu G, Gao Y, Tian L, Yao L, Zheng Y, Zhao Q, Liu K. Potent potentiating diuretic effects of prednisone in congestive heart failure. J Cardiovasc Pharmacol. 2006 Oct;48(4):173-6. doi: 10.1097/01.fjc.0000245242.57088.5b.
PubMed 17086096
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00369044
- Acronym / sponsor ID
- 200608A
- Conditions
- Heart Failure, Congestive
- Keywords
- decompensated heart failure, prednisone, diuretics, diuresis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jul 2008 (estimated)
- First posted
- 29 Aug 2006 (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.
We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.
Detailed description
Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hospitalized with primary diagnosis of CHF
- Patients with normal cortical function
- LVEF <40%
- Significant fluid overload, defined as ≥ 2 of the following
Key exclusion criteria (8 listed)
- Severe stenotic valvular disease
- Serum creatinine > 4 mg/dl
- Patient refusal
- Any signs of infection or any condition that would contraindicate an glucocorticoids use
- Poor controlled hypertension
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 |
|---|---|---|
| prednisone | Drug | – |
Primary outcome
Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2
1 secondary outcome
Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
- Background: PubMed 17086096Liu C, Chen H, Zhou C, Ji Z, Liu G, Gao Y, Tian L, Yao L, Zheng Y, Zhao Q, Liu K. Potent potentiating diuretic effects of prednisone in congestive heart failure. J Cardiovasc Pharmacol. 2006 Oct;48(4):173-6. doi: 10.1097/01.fjc.0000245242.57088.5b.
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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.
Kunshen Liu, MD principal investigator
The First Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing prednisone in people with Heart Failure, Congestive, run by Hebei Medical University at 1 site 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 8 inclusion and 8 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: paused, as of the sponsor's last update on 8 Apr 2009. 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 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 combined 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.
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?
Results are not available in the source record.
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?
Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2. 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 NCT00369044, 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 8 Apr 2009; AzTrials last refreshed its copy on 30 Oct 2026.