Acute Heart FailurePhase 2NCT02299726
Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study
A Phase 2 study testing Spironolactone in people with Acute Heart Failure, run by Indiana University.
Trial summary
Over one million hospitalizations for acute heart failure (AHF) occur over every year in the United States, resulting in high mortality, re-hospitalizations, and incurred financial costs; yet nearly every attempt over the last 10 years to improve outcomes with novel therapies have all failed. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Nov 2018
- Phase
- Phase 2
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male or female, age ≥ 21 years
- Primary reason for admission is acute heart failure requiring IV loop diuretic therapy either in the emergency department (ED) or within 6 hours after direct hospital admission.
- Enrolled within 12 hours of first dose of IV loop diuretic therapy
- BNP > 300 pg/mL and/or NT-ProBNP > 1200 pg/mL by local laboratory
- At least 1 of the following: Jugular Venous Distention, Peripheral edema, Radiographic evidence of pulmonary congestion
- Ejection Fraction ≤ 40% within past 12 months by any method
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- Able to take oral medications
- Able to provide written informed consent
- Agrees to a minimum of 3 blood draws up to 72 hours from randomization
Who cannot join
- • Potassium ≥ 4.8mEq
- eGFR (by sMDRD) < 45 ml/min/1.73 m2 or a worsening by 50% or more compared to any measurement in the last 6 months or planned ultrafiltration
- History of or planned organ transplantation of any kind within the next 90 days
- Invasive mechanical ventilatory support (non-invasive positive pressure ventilation is allowed)
- Cardiogenic shock and/or treatment or planned treatment with inotropic or vasopressor medications (e.g. dobutamine, dopamine, milrinone, norepinephrine) or intra-aortic balloon pump
- Refractory, end-stage HF defined as subjects who are appropriate candidates for specialized treatment strategies, such as transplant, ventricular assist devices, continuous intravenous inotropic therapy, or hospice care
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- Co-morbid condition with an expected survival <6 months or active cancer
- History of stroke, cardiac surgery, or ACS currently or within past 60 days
- Temperature ≥101.5 degrees F
- Severe valvular or liver disease
- On digoxin or history of MRA allergy or adverse drug reaction
- Women who are currently pregnant or report a recent pregnancy (last 60 days) or plan on becoming pregnant during the next 4 months
- Participation in another drug or device trial in which the last dose of drug was within the past 30 days or an investigational medical device has been implanted
About this study
Over one million hospitalizations for acute heart failure (AHF) occur over every year in the United States, resulting in high mortality, re-hospitalizations, and incurred financial costs; yet nearly every attempt over the last 10 years to improve outcomes with novel therapies have all failed. In this proposal, we will study whether a generic drug known as a mineralocorticoid receptor antagonist (more commonly known as an aldosterone blocker), proven to reduce morbidity and mortality for chronic heart failure patients, is safe and feasible to give to AHF patients in the emergency department and during hospitalization for a total of 3 days. The results of this study will provide necessary and sufficient data to design an efficacy study in a larger population to test whether early use of a high-dose of mineralocorticoid receptor antagonists will reduce post-discharge morbidity and mortality.
Read the detailed description
This clinical trial pilot study - Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study - will explore the safety of early mineralocorticoid receptor blockade with high-dose spironolactone (100mg/daily), an oral mineralocorticoid receptor antagonist, versus placebo (both in addition to standard therapy), in patients admitted with acute heart failure (AHF) for 3 days. Aim 1 will answer the critical question that early mineralocorticoid receptor (MR) antagonism in AHF patients is sufficiently safe to move forward with a definitive trial. Aim 2 will demonstrate feasibility of patient enrollment and compliance with treatment throughout the study to inform future study design and enrollment projections. This study will provide the necessary and sufficient data in order to plan a larger, simple, definitive trial to test the hypothesis that early aldosterone blockade in AHF patients will reduce mortality and 30-day readmissions.
The primary endpoint for the pilot study will be the difference in incidence of mean change of serum potassium of a specific amount from baseline to 120 hours from initial dose between placebo vs. spironolactone treated subjects.
- Conditions
- Acute Heart Failure
- Being tested
- Spironolactone, Placebo
- Keywords
- acute heart failure, MRA, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | spironolactone Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | matching placebo to active study drug Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Potassium from baseline through 5 days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Study was not funded
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 Indiana 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University, Wayne State University
- Responsible party
- Principal investigator, Peter Pang, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299726
- Sponsor's protocol ID
- 1R34HL118350-01A1
- Status last verified
- Apr 2017
- First submitted
- 17 Nov 2014
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study
- ClinicalTrials.gov ID
- NCT02299726
- Acronym / sponsor ID
- 1R34HL118350-01A1
- Conditions
- Acute Heart Failure
- Keywords
- acute heart failure, MRA, emergency department
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University, Wayne State University
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 24 Nov 2014 (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.
Over one million hospitalizations for acute heart failure (AHF) occur over every year in the United States, resulting in high mortality, re-hospitalizations, and incurred financial costs; yet nearly every attempt over the last 10 years to improve outcomes with novel therapies have all failed. In this proposal, we will study whether a generic drug known as a mineralocorticoid receptor antagonist (more commonly known as an aldosterone blocker), proven to reduce morbidity and mortality for chronic heart failure patients, is safe and feasible to give to AHF patients in the emergency department and during hospitalization for a total of 3 days. The results of this study will provide necessary and sufficient data to design an efficacy study in a larger population to test whether early use of a high-dose of mineralocorticoid receptor antagonists will reduce post-discharge morbidity and mortality.
Detailed description
This clinical trial pilot study - Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study - will explore the safety of early mineralocorticoid receptor blockade with high-dose spironolactone (100mg/daily), an oral mineralocorticoid receptor antagonist, versus placebo (both in addition to standard therapy), in patients admitted with acute heart failure (AHF) for 3 days. Aim 1 will answer the critical question that early mineralocorticoid receptor (MR) antagonism in AHF patients is sufficiently safe to move forward with a definitive trial. Aim 2 will demonstrate feasibility of patient enrollment and compliance with treatment throughout the study to inform future study design and enrollment projections. This study will provide the necessary and sufficient data in order to plan a larger, simple, definitive trial to test the hypothesis that early aldosterone blockade in AHF patients will reduce mortality and 30-day readmissions.
The primary endpoint for the pilot study will be the difference in incidence of mean change of serum potassium of a specific amount from baseline to 120 hours from initial dose between placebo vs. spironolactone treated subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Spironolactonespironolactone |
| Placebo | Placebo comparator | Other: Placebomatching placebo to active study drug |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Male or female, age ≥ 21 years
Key exclusion criteria (13 listed)
- • Potassium ≥ 4.8mEq
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 |
|---|---|---|
| Spironolactone | Drug | Active |
| PlaceboMatching placebo | Other | Placebo |
Primary outcome
Change in Potassium from baseline through 5 days
Time frame: 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone in people with Acute Heart Failure, run by Indiana University.
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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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 Potassium from baseline through 5 days (time frame: 5 days). 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 21 Apr 2017.