Acute Decompensated Heart FailureNCT02823626
High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure
An observational study of Acute Decompensated Heart Failure, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Primary Aims 1. Evaluate the safety of high-dose spironolactone in combination of patiromer in acute decompensated heart failure patients. 2. Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing volume loss and symptom relief in patients with ADHF treated with high-dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Spironolactone and patiromer
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Apr 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will have been hospitalized with a diagnosis of chronic heart failure.
Who may be able to join
- More than18 years old
- Hospitalized with history of chronic heart failure and at least one symptom (dyspnea, orthopnea or edema) and one sign (rales, peripheral edema, ascites, or radiographic pulmonary edema or pleural effusion)
- Use of loop diuretics
- Women of child bearing age with negative urine pregnancy test
Who cannot join
- Acute coronary syndrome
- Patients with a baseline eGFR < 30 ml/min by MDRD equation
- Baseline potassium concentration ≥ 5.5 mEq/L
- Requirement for intravenous vasodilators or inotropic agents
- Systemic infection
- Patients with concomitant end-stage liver disease
Show all 10Show fewer
- Hemodynamically significant uncorrected valvular disease
- Patients with pulmonary embolism
- Patients with high output heart failure
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Primary Aims
- Evaluate the safety of high-dose spironolactone in combination of patiromer in acute decompensated heart failure patients.
- Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing volume loss and symptom relief in patients with ADHF treated with high-dose spironolactone.
Secondary Aims
1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal function.
Read the detailed description
Step-by-Step Methods:
Pre-screening: Patients meeting the inclusion and exclusion criteria will be approached to participate in the study. Informed consent will be taken at this time. These patients will receive intravenous loop diuretic per the discretion of treating physician and will be closely followed for weight loss and symptoms relief.
Screening: The patients who don't respond as measured by symptoms relief or <0.5 kg weight loss/day
- Despite furosemide ≥ 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. (1 mg bumetanide = 10 mg torsemide = 20 mg furosemide). OR
- After 48 hours irrespective of diuretic dose. will be considered for the study intervention. Patients who have not participated in the pre-screening phase and do not respond adequately to furosemide >160 mg iv daily dose will directly be enrolled into active intervention part of the study.
Intervention (High-Dose Spironolactone + Patiromer): Patients will be initiated on spironolactone 100 mg orally once daily along with patiromer 8.4 gm orally (if serum K >4.3 meq/L). The dose of loop diuretic will stay same during rest of the study period. On day 2, the dose of spironolactone will be titrated to 200 mg orally once a day depending on the diuretic response and lab results. Serum potassium will be monitored twice a day. The dose of patiromer will be increased to 16.8 gm in patients with potassium levels exceeding 5.5 meq/L; or it will be held for serum K <4.3 mEq/L. Treatment will continue till patients achieve euvolemia or get discharged. Euvolemia is defined as resolution of symptoms and signs of volume overload.
Patients will be followed till achievement of euvolemia or discharge. Daily assessment will be done for symptoms, and signs of volume overload including shortness of breath, orthopnea, paroxysmal nocturnal dyspnea, abdominal bloating, lower extremity edema, JVD, and body weight changes. Serum chemistry will be assessed twice a day and urine electrolytes once a day. Neurohormonal analysis will be done at the pre-screening, initiation of active intervention and at the end of the study duration.
Primary Safety Endpoints:
- Incidence of hyperkalemia as defined by serum K >5.5 meq/day.
- Renal function: assessed by daily serum creatinine
Primary Efficacy Endpoints:
- Weight loss: using same calibrated scale every day in hospital gown.
- Symptom relief: assessed using a 5-point Likert scale describing magnitude of shortness of breath while the patient is in the supine position.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Spironolactone and patiromer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone and patiromerDrug
Also called Aldactone and veltassa
High dose spironolactone with or without patiromer based on the patient's baseline potassium
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Spironolactone and patiromer Receives: Drug: Spironolactone and patiromer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Improved swelling and shortness of breath suggestive of volume loss
Measured: up to 10 days
symptoms relief
Improved swelling and shortness of breath suggestive of volume loss
Measured: up to 10 days
Secondary outcomes (2)
Hypo- or hyperkalemia
Serum potassium <3.5 or >5.5 meq/l
Measured: up to 10 days
Urinary FENa and Urinary Na/K ratio
to measure the sodium loss
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Relypsa, Inc.
- Responsible party
- Sponsor
- Investigators
- Shweta Bansal, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823626
- Sponsor's protocol ID
- HSC20160252H
- Status last verified
- Apr 2018
- First submitted
- 27 Jun 2016
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT02823626
- Acronym / sponsor ID
- HSC20160252H
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Relypsa, Inc.
- Study start
- Sep 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 6 Jul 2016 (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.
Primary Aims
- Evaluate the safety of high-dose spironolactone in combination of patiromer in acute decompensated heart failure patients.
- Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing volume loss and symptom relief in patients with ADHF treated with high-dose spironolactone.
Secondary Aims
1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal function.
Detailed description
Step-by-Step Methods:
Pre-screening: Patients meeting the inclusion and exclusion criteria will be approached to participate in the study. Informed consent will be taken at this time. These patients will receive intravenous loop diuretic per the discretion of treating physician and will be closely followed for weight loss and symptoms relief.
Screening: The patients who don't respond as measured by symptoms relief or <0.5 kg weight loss/day
- Despite furosemide ≥ 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. (1 mg bumetanide = 10 mg torsemide = 20 mg furosemide). OR
- After 48 hours irrespective of diuretic dose. will be considered for the study intervention. Patients who have not participated in the pre-screening phase and do not respond adequately to furosemide >160 mg iv daily dose will directly be enrolled into active intervention part of the study.
Intervention (High-Dose Spironolactone + Patiromer): Patients will be initiated on spironolactone 100 mg orally once daily along with patiromer 8.4 gm orally (if serum K >4.3 meq/L). The dose of loop diuretic will stay same during rest of the study period. On day 2, the dose of spironolactone will be titrated to 200 mg orally once a day depending on the diuretic response and lab results. Serum potassium will be monitored twice a day. The dose of patiromer will be increased to 16.8 gm in patients with potassium levels exceeding 5.5 meq/L; or it will be held for serum K <4.3 mEq/L. Treatment will continue till patients achieve euvolemia or get discharged. Euvolemia is defined as resolution of symptoms and signs of volume overload.
Patients will be followed till achievement of euvolemia or discharge. Daily assessment will be done for symptoms, and signs of volume overload including shortness of breath, orthopnea, paroxysmal nocturnal dyspnea, abdominal bloating, lower extremity edema, JVD, and body weight changes. Serum chemistry will be assessed twice a day and urine electrolytes once a day. Neurohormonal analysis will be done at the pre-screening, initiation of active intervention and at the end of the study duration.
Primary Safety Endpoints:
- Incidence of hyperkalemia as defined by serum K >5.5 meq/day.
- Renal function: assessed by daily serum creatinine
Primary Efficacy Endpoints:
- Weight loss: using same calibrated scale every day in hospital gown.
- Symptom relief: assessed using a 5-point Likert scale describing magnitude of shortness of breath while the patient is in the supine position.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Drug: Spironolactone and patiromerSpironolactone and patiromer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will have been hospitalized with a diagnosis of chronic heart failure.
Key inclusion criteria (4 listed)
- More than18 years old
- Hospitalized with history of chronic heart failure and at least one symptom (dyspnea, orthopnea or edema) and one sign (rales, peripheral edema, ascites, or radiographic pulmonary edema or pleural effusion)
- Use of loop diuretics
- Women of child bearing age with negative urine pregnancy test
Key exclusion criteria (10 listed)
- Acute coronary syndrome
- Patients with a baseline eGFR < 30 ml/min by MDRD equation
- Baseline potassium concentration ≥ 5.5 mEq/L
- Requirement for intravenous vasodilators or inotropic agents
- Systemic infection
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 and patiromerAlso: Aldactone and veltassaHigh dose spironolactone with or without patiromer based on the patient's baseline potassium | Drug | Intervention |
Primary outcome
Weight loss
Time frame: up to 10 days
Improved swelling and shortness of breath suggestive of volume loss
symptoms relief
Time frame: up to 10 days
Improved swelling and shortness of breath suggestive of volume loss
2 secondary outcomes
Hypo- or hyperkalemia
Time frame: up to 10 days
Urinary FENa and Urinary Na/K ratio
Time frame: Up to 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 3 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated 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.
Shweta Bansal principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 10 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 3 May 2019. 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 United States. 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.
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?
Weight loss (time frame: up to 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?
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 3 May 2019.