HyponatremiaPhase 3CONVERT-HNCT00843986
Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)
A Phase 3 study testing conivaptan in people with Hyponatremia and Acute Decompensated Heart Failure, run by Cumberland Pharmaceuticals at 4 sites in India.
Trial summary
This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Acute Decompensated Heart Failure
- What is being tested?
- conivaptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 4 sitesIndia
- Study dates
- Apr 2009to Aug 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Presents to emergency department with documented history of CHF and symptomatic ADHF, will be treated for ADHF, and primary reason for admission to the hospital is ADHF
- Dyspnea at rest or with minimal exertion and must have moderate shortness of breath (SOB) in any of the first three Provocative Dyspnea Assessment positions
- Severe pulmonary congestion as evidenced by jugular venous distention or lower extremity/sacral edema or rales upon chest auscultation or chest x-ray.
- BNP > 400 or NT-pro BNP > 1500 drawn during Screening
- Systolic blood pressure >= 100 mmHg to < 180 mmHg at time of start of study drug
- Serum sodium value >= 115 mEq/L (115 mmol/L) and < 135 mEq/L (135 mmol/L) during Screening
Who cannot join
- Clinical evidence of volume depletion
- Active ongoing acute coronary syndrome or acute ST segment elevation myocardial infarction (or has experienced a myocardial infarction within 30 days of Screening)
- In cardiogenic shock
- Calculated creatinine clearance < 30 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) equation, has received intravenous (IV) contrast agent within 72 hours prior to randomization or is expected to receive IV contrast agent within the first 72 hours of study participation
- Ultrafiltration within the past 72 hours.
- Currently using or expected to use inotropic therapy
Show all 16Show fewer
- Cardiac bypass grafts in the past 60 days
- Cerebrovascular accident in the past 30 days
- Uncontrolled brady- or ventricular tachyarrhythmias requiring emergent pacemaker placement or treatment
- Hemodynamically significant uncorrected primary cardiac valvular disease or hypertrophic cardiomyopathy
- Untreated severe hypothyroidism, hyperthyroidism or adrenal insufficiency based on medical history
- ALT or AST elevations > 5 times upper limit of normal
- Biliary liver cirrhosis, history or presence of severe hepatic encephalopathy, ascites, esophageal variceal bleeding within the past three months, severe portal hypertension or surgical portosystemic shunt.
- Received any organ transplant, clinical diagnosis of pneumonia, symptomatic hyponatremia requiring urgent intervention or any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety
- Pregnant or lactating
- Currently using vasopressin, oxytocin or desmopressin
Trial locations and contacts
4 sites in 1 country.
India4 sites
Study site
Hyderabaad, 500063
Study site
Karnāl, 132001
Study site
New Delhi, 110025
Study site
New Delhi, 110060
About this study
Official title: A Phase-3b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety and Efficacy of Conivaptan in Symptomatic Acute Decompensated Heart Failure (ADHF) Subjects With Hyponatremia
This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
Read the detailed description
Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.
- Conditions
- Hyponatremia, Acute Decompensated Heart Failure
- Being tested
- conivaptan, placebo
- Keywords
- hyponatremia, euvolemic hyponatremia, hypervolemic hyponatremia, acute decompensated heart failure, conivaptan, Vaprisol
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conivaptanDrug
Also called Vaprisol; YM087
Premix bag
placeboDrug
Premix bag
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching loading dose and continuous intravenous infusion for 48 hours Receives: Drug: placebo |
| Conivaptan | Experimental | 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours Receives: Drug: conivaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)
MDRD = Modification of Diet in Renal Disease
The MDRD equation is a standard calculation for estimated glomerular filtration rate.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: Baseline and 72 Hours
Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale
Dyspnea is defined as the sensation of uncomfortable or difficult breathing.
Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: 24 Hours
Secondary outcomes (9)
Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: Baseline, 24 Hours, 48 Hours and 72 Hours
Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance
Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation.
MDRD = Modification of Diet in Renal Disease
The MDRD equation is a standard calculation for estimated glomerular filtration rate.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: Baseline, 24 Hours, 48 Hours and Day 9
Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: Day 9
Termination of Study Drug Due to an Adverse Event or Intolerability
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: 48.5 Hours
Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment
Dyspnea is defined as the sensation of uncomfortable or difficult breathing.
Changes in Dyspnea were assessed using the following 7-point Likert scale:
1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours
Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment
Dyspnea is defined as the sensation of uncomfortable or difficult breathing.
The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity).
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours
Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge)
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9
Total Loop Diuretic Use Through 48 Hours
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: 48 Hours
Total Urine Output at Hours 6, 12, 24, 48 and 72
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Measured: 6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: The clinical study has been terminated based on difficulties to enroll eligible subjects per protocol inclusion and exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyponatremiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Art Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843986
- Sponsor's protocol ID
- 087-CL-301
- Acronym
- CONVERT-H
- Status last verified
- Apr 2014
- First submitted
- 11 Feb 2009
- Last updated
- 15 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-3b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety and Efficacy of Conivaptan in Symptomatic Acute Decompensated Heart Failure (ADHF) Subjects With Hyponatremia
- ClinicalTrials.gov ID
- NCT00843986
- Acronym / sponsor ID
- CONVERT-H / 087-CL-301
- Conditions
- Hyponatremia, Acute Decompensated Heart Failure
- Keywords
- hyponatremia, euvolemic hyponatremia, hypervolemic hyponatremia, acute decompensated heart failure, conivaptan, Vaprisol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical study has been terminated based on difficulties to enroll eligible subjects per protocol inclusion and exclusion criteria.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Posted 1 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
Detailed description
Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboMatching loading dose and continuous intravenous infusion for 48 hours |
| Conivaptan | Experimental | Drug: conivaptan20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presents to emergency department with documented history of CHF and symptomatic ADHF, will be treated for ADHF, and primary reason for admission to the hospital is ADHF
- Dyspnea at rest or with minimal exertion and must have moderate shortness of breath (SOB) in any of the first three Provocative Dyspnea Assessment positions
- Severe pulmonary congestion as evidenced by jugular venous distention or lower extremity/sacral edema or rales upon chest auscultation or chest x-ray.
- BNP > 400 or NT-pro BNP > 1500 drawn during Screening
- Systolic blood pressure >= 100 mmHg to < 180 mmHg at time of start of study drug
Key exclusion criteria (16 listed)
- Clinical evidence of volume depletion
- Active ongoing acute coronary syndrome or acute ST segment elevation myocardial infarction (or has experienced a myocardial infarction within 30 days of Screening)
- In cardiogenic shock
- Calculated creatinine clearance < 30 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) equation, has received intravenous (IV) contrast agent within 72 hours prior to randomization or is expected to receive IV contrast agent within the first 72 hours of study participation
- Ultrafiltration within the past 72 hours.
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 |
|---|---|---|
| conivaptanAlso: Vaprisol; YM087Premix bag | Drug | Conivaptan |
| placeboPremix bag | Drug | Placebo |
Primary outcome
Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)
Time frame: Baseline and 72 Hours
MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale
Time frame: 24 Hours
Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
9 secondary outcomes
Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance
Time frame: Baseline, 24 Hours, 48 Hours and 72 Hours
Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance
Time frame: Baseline, 24 Hours, 48 Hours and Day 9
Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function
Time frame: Day 9
Termination of Study Drug Due to an Adverse Event or Intolerability
Time frame: 48.5 Hours
Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment
Time frame: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours
Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment
Time frame: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours
Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge)
Time frame: Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9
Total Loop Diuretic Use Through 48 Hours
Time frame: 48 Hours
Total Urine Output at Hours 6, 12, 24, 48 and 72
Time frame: 6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to Prescribing InformationLink provided by the sponsor.
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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.
Art Wheeler, MD study director
Cumberland Pharmaceuticals
4 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 conivaptan in people with Hyponatremia and Acute Decompensated Heart Failure, run by Cumberland Pharmaceuticals at 4 sites in India.
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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation) (time frame: Baseline and 72 Hours). 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?
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 15 May 2014.