Heart FailurePhase 4NCT02429388
High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure
A Phase 4 study testing Spironolactone in people with Heart Failure, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Oct 2015
- Phase
- Phase 4
- 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
Who may be able to join
- 18 years or older patients with congestive heart failure
- Hypervolemic by at least 2 of the following criteria: 1) Peripheral edema; 2) jugular venous distention greater than 7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea
- Diuretic resistance as defined by loop diuretic requirements of furosemide greater or equal to 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. ( 1 mg bumetanide = 10 mg torsemide = 20 mg furosemide)
- Estimated glomerular filtration rate (eGFR) of > 30ml/min. according to the MDRD Study equation at the time of admission.
- Female patients of child bearing potential must have a negative urine pregnancy test to be eligible.
Who cannot join
- Acute coronary syndrome
- Patients with a baseline eGFR < 30 ml/min according to the MDRD equation.
- Baseline potassium serum concentration 5.3 meq/L
- Requirement for intravenous pressors
- Systemic infection
- Patients with concomitant end-stage liver disease
Show all 10Show fewer
- Significant 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
Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care.
Read the detailed description
Congestive heart failure (CHF) is common and currently affects an estimated 6.6 million adults in the United States (1). In addition being highly prevalent, CHF is responsible for ~ 1 million hospital discharges per year and approximately 50% of patients with CHF will die within 5 years making it a highly morbid and lethal disease (1).
Manifestations of CHF include symptoms of volume overload such as dyspnea, abdominal bloating and/or fatigue. The genesis of these symptoms begins with loss of the integrity of arterial circulation due to decreased cardiac output (2). Decreased activation of mechanoreceptors in the carotid sinus, left ventricle, aortic arch and renal afferent arterioles due to lower systemic arterial pressure stimulates the sympathetic nervous system (SNS), renal-angiotensin-aldosterone system (RAAS) and non-osmotic release of arginine vasopressin (3). As a result, sodium reabsorption in the proximal tubule followed by water absorption increases causing accumulation of intravascular volume to compensating for arterial underfilling (4). Consequently, activation of neurohumoral reflexes result in increased cardiac afterload and preload, cardiac remodeling, hyponatremia and pulmonary edema (5). Renal vasoconstriction, sodium and water retention leads to a continuous positive feedback loop of further salt and water accumulation accompanied by further renal vasoconstriction (6).
Diuretic therapy is the most common means to relieve congestion in acute decompensated heart failure (ADHF) and approximately 90% of patients are treated with loop diuretics (7). Although loop diuretics are a cornerstone ADHF care and carries the highest level of recommendation by the American Heart Association (Class I); the guideline is supported by the lowest level of evidence (Class C) (8). While effective at natriuresis, loop diuretics are known to stimulate the SNS and RAAS, both of which have adverse consequence in heart failure (9,10). Not only is the RAAS system stimulated due to changes in arterial filling, furosemide blocks sodium chloride transport at the macula densa causing renin release independent of renal sodium loss (11). With increase stimulation of renin release, vasoconstriction of the renal artery ensues causing or further exacerbating renal insufficiency (12). Long-term utilization of loop diuretics results in hypertrophy of the distal nephron and increased expression of a sodium chloride co-transporter (13). These changes along with increased aldosterone levels further enhances distal sodium reabsorption and prevents aldosterone escape (14).
In treating heart failure patients as a population, diuretic resistance is encountered commonly and escalating doses of furosemide may be utilized to achieve fluid loss (15). Clinically, use of high-doses of loop diuretics is associated with greater rates of clinical events such as mechanical ventilation and myocardial infarction compared to low-dose loop diuretics (16). High-dose loop diuretic administration is associated with worsening renal function (17), increased length of hospital stay and greater in-hospital mortality (17-19). There is in fact a linear correlation with diuretic dose and mortality (20).
Given the potential hazards of administering loop diuretics in CHF patients, the remaining options are limited. Changing diuretics strategies from bolus to continuous loop diuretic infusion does not appear to change overall outcomes (21). Alternative strategies for relieving congestion include inhibition of the distal nephron using thiazide diuretics. Thiazide diuretics work synergistically with loop diuretics to induce natriuresis but have an independent association with worsening renal function and death (20,22). Utilizing inotropes to increasing renal perfusion pressure may improve natriuresis, however, it comes with the price of increasing mortality regardless of whether beta-adrenergic agonists (dobutamine) or phosphodiesterase inhibitors are used (23,24). Ultrafiltration and mechanical unloading of the heart is another therapeutic option, however it was found to be ineffective and associated with worsening renal function (25). Even low doses of dopamine or nesiritide were not effective in improving outcomes in patients with cardiorenal syndrome (26). Higher doses of spironolactone were recently shown to be safe in a prospective cohort treated for acute decompensated heart failure (27). Recently a case report was published showing that patients hospitalized with congestive heart failure, worsening renal function and diuretic resistance were able to be diuresed without adverse effect on renal function or hyperkalemia by treating with escalating doses of spironolactone (28)
The study will be a prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status, urine and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care.
- Conditions
- Heart Failure
- Being tested
- Spironolactone
- Keywords
- Heart failure, Spironolactone, Diuretics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called aldactone, potassium-sparing diuretics
Administration of spironolactone 25-50mg orally twice daily for two days and subsequently titrated upto 100mg twice daily with daily serum potassium monitoring. Spironolactone will continue until patient is euvolemic and appropriate for discharge. Titration of loop diuretics in this arm will not be escalated.
| Study group | Role | What they receive |
|---|---|---|
| High dose spironolactone | Experimental | This arm of the study will include addition of high dose spironolactone upto 100mg twice daily in adjunct to usual care of hospitalized acute decompensated heart failure patients with loop diuretics. Receives: Drug: Spironolactone |
| Usual Care | No intervention | This arm of the study will continue the usual care of hospitalized acute decompensated heart failure patients with loop diuretics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of adjunctive high-dose Spironolactone on weight loss.
Weight will be tracked from enrollment to 7 days or when patient reaches euvolemia for all patients, whichever occurs first.
Measured: 7 days
Secondary outcomes (3)
Efficacy of adjunctive high-dose Spironolactone on dyspnea.
Using Likert scale, dyspnea and functional status will be assessed at enrollment and re-evaluate at 7days or at euvolemia for all patients, whichever occurs first.
Measured: 7 days
Risk of hyperkalemia and renal dysfunction with use of adjunctive high-dose Spironolactone.
Assessment of serum potassium and creatinine daily on all patients to assess relative safety of spironolactone use in diuretic resistant heart failure patients.
Measured: 7 days
Length of hospitalization
Comparison of length of hospitalization with use of high dose spironolactone to heart failure therapy compared to usual care.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Principal Investigator left institution prior to subjects being enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marvin H Eng, M.D., Principal investigator, University of Texas Heatlh Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429388
- Sponsor's protocol ID
- HSC20140274H
- Status last verified
- Apr 2016
- First submitted
- 27 Sep 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
PubMed 22179539Schrier RW, Abraham WT. Hormones and hemodynamics in heart failure. N Engl J Med. 1999 Aug 19;341(8):577-85. doi: 10.1056/NEJM199908193410806. No abstract available.
PubMed 10451464Schrier RW. Water and sodium retention in edematous disorders: role of vasopressin and aldosterone. Am J Med. 2006 Jul;119(7 Suppl 1):S47-53. doi: 10.1016/j.amjmed.2006.05.007.
PubMed 16843085Schrier RW. Decreased effective blood volume in edematous disorders: what does this mean? J Am Soc Nephrol. 2007 Jul;18(7):2028-31. doi: 10.1681/ASN.2006111302. Epub 2007 Jun 13.
PubMed 17568020Hirsch AT, Pinto YM, Schunkert H, Dzau VJ. Potential role of the tissue renin-angiotensin system in the pathophysiology of congestive heart failure. Am J Cardiol. 1990 Oct 2;66(11):22D-30D; discussion 30D-32D. doi: 10.1016/0002-9149(90)90473-e.
PubMed 2220602Schrier RW, De Wardener HE. Tubular reabsorption of sodium ion: influence of factors other than aldosterone and glomerular filtration rate. 2. N Engl J Med. 1971 Dec 2;285(23):1292-303. doi: 10.1056/NEJM197112022852305. No abstract available.
PubMed 4398836Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
PubMed 15846257Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.
PubMed 16160202Francis GS, Goldsmith SR, Levine TB, Olivari MT, Cohn JN. The neurohumoral axis in congestive heart failure. Ann Intern Med. 1984 Sep;101(3):370-7. doi: 10.7326/0003-4819-101-3-370.
PubMed 6147109Bayliss J, Norell M, Canepa-Anson R, Sutton G, Poole-Wilson P. Untreated heart failure: clinical and neuroendocrine effects of introducing diuretics. Br Heart J. 1987 Jan;57(1):17-22. doi: 10.1136/hrt.57.1.17.
PubMed 3541995He XR, Greenberg SG, Briggs JP, Schnermann J. Effects of furosemide and verapamil on the NaCl dependency of macula densa-mediated renin secretion. Hypertension. 1995 Jul;26(1):137-42. doi: 10.1161/01.hyp.26.1.137.
PubMed 7607716Ellison DH. Diuretic therapy and resistance in congestive heart failure. Cardiology. 2001;96(3-4):132-43. doi: 10.1159/000047397.
PubMed 11805380Abdallah JG, Schrier RW, Edelstein C, Jennings SD, Wyse B, Ellison DH. Loop diuretic infusion increases thiazide-sensitive Na(+)/Cl(-)-cotransporter abundance: role of aldosterone. J Am Soc Nephrol. 2001 Jul;12(7):1335-1341. doi: 10.1681/ASN.V1271335.
PubMed 11423562Ellison DH, Velazquez H, Wright FS. Adaptation of the distal convoluted tubule of the rat. Structural and functional effects of dietary salt intake and chronic diuretic infusion. J Clin Invest. 1989 Jan;83(1):113-26. doi: 10.1172/JCI113847.
PubMed 2910903Bansal S, Lindenfeld J, Schrier RW. Sodium retention in heart failure and cirrhosis: potential role of natriuretic doses of mineralocorticoid antagonist? Circ Heart Fail. 2009 Jul;2(4):370-6. doi: 10.1161/CIRCHEARTFAILURE.108.821199.
PubMed 19808361
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure
- ClinicalTrials.gov ID
- NCT02429388
- Acronym / sponsor ID
- HSC20140274H
- Conditions
- Heart Failure
- Keywords
- Heart failure, Spironolactone, Diuretics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left institution prior to subjects being enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Apr 2015 (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.
Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care.
Detailed description
Congestive heart failure (CHF) is common and currently affects an estimated 6.6 million adults in the United States (1). In addition being highly prevalent, CHF is responsible for ~ 1 million hospital discharges per year and approximately 50% of patients with CHF will die within 5 years making it a highly morbid and lethal disease (1).
Manifestations of CHF include symptoms of volume overload such as dyspnea, abdominal bloating and/or fatigue. The genesis of these symptoms begins with loss of the integrity of arterial circulation due to decreased cardiac output (2). Decreased activation of mechanoreceptors in the carotid sinus, left ventricle, aortic arch and renal afferent arterioles due to lower systemic arterial pressure stimulates the sympathetic nervous system (SNS), renal-angiotensin-aldosterone system (RAAS) and non-osmotic release of arginine vasopressin (3). As a result, sodium reabsorption in the proximal tubule followed by water absorption increases causing accumulation of intravascular volume to compensating for arterial underfilling (4). Consequently, activation of neurohumoral reflexes result in increased cardiac afterload and preload, cardiac remodeling, hyponatremia and pulmonary edema (5). Renal vasoconstriction, sodium and water retention leads to a continuous positive feedback loop of further salt and water accumulation accompanied by further renal vasoconstriction (6).
Diuretic therapy is the most common means to relieve congestion in acute decompensated heart failure (ADHF) and approximately 90% of patients are treated with loop diuretics (7). Although loop diuretics are a cornerstone ADHF care and carries the highest level of recommendation by the American Heart Association (Class I); the guideline is supported by the lowest level of evidence (Class C) (8). While effective at natriuresis, loop diuretics are known to stimulate the SNS and RAAS, both of which have adverse consequence in heart failure (9,10). Not only is the RAAS system stimulated due to changes in arterial filling, furosemide blocks sodium chloride transport at the macula densa causing renin release independent of renal sodium loss (11). With increase stimulation of renin release, vasoconstriction of the renal artery ensues causing or further exacerbating renal insufficiency (12). Long-term utilization of loop diuretics results in hypertrophy of the distal nephron and increased expression of a sodium chloride co-transporter (13). These changes along with increased aldosterone levels further enhances distal sodium reabsorption and prevents aldosterone escape (14).
In treating heart failure patients as a population, diuretic resistance is encountered commonly and escalating doses of furosemide may be utilized to achieve fluid loss (15). Clinically, use of high-doses of loop diuretics is associated with greater rates of clinical events such as mechanical ventilation and myocardial infarction compared to low-dose loop diuretics (16). High-dose loop diuretic administration is associated with worsening renal function (17), increased length of hospital stay and greater in-hospital mortality (17-19). There is in fact a linear correlation with diuretic dose and mortality (20).
Given the potential hazards of administering loop diuretics in CHF patients, the remaining options are limited. Changing diuretics strategies from bolus to continuous loop diuretic infusion does not appear to change overall outcomes (21). Alternative strategies for relieving congestion include inhibition of the distal nephron using thiazide diuretics. Thiazide diuretics work synergistically with loop diuretics to induce natriuresis but have an independent association with worsening renal function and death (20,22). Utilizing inotropes to increasing renal perfusion pressure may improve natriuresis, however, it comes with the price of increasing mortality regardless of whether beta-adrenergic agonists (dobutamine) or phosphodiesterase inhibitors are used (23,24). Ultrafiltration and mechanical unloading of the heart is another therapeutic option, however it was found to be ineffective and associated with worsening renal function (25). Even low doses of dopamine or nesiritide were not effective in improving outcomes in patients with cardiorenal syndrome (26). Higher doses of spironolactone were recently shown to be safe in a prospective cohort treated for acute decompensated heart failure (27). Recently a case report was published showing that patients hospitalized with congestive heart failure, worsening renal function and diuretic resistance were able to be diuresed without adverse effect on renal function or hyperkalemia by treating with escalating doses of spironolactone (28)
The study will be a prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status, urine and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose spironolactone | Experimental | Drug: SpironolactoneThis arm of the study will include addition of high dose spironolactone upto 100mg twice daily in adjunct to usual care of hospitalized acute decompensated heart failure patients with loop diuretics. |
| Usual Care | No intervention | –This arm of the study will continue the usual care of hospitalized acute decompensated heart failure patients with loop diuretics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older patients with congestive heart failure
- Hypervolemic by at least 2 of the following criteria: 1) Peripheral edema; 2) jugular venous distention greater than 7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea
- Diuretic resistance as defined by loop diuretic requirements of furosemide greater or equal to 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. ( 1 mg bumetanide = 10 mg torsemide = 20 mg furosemide)
- Estimated glomerular filtration rate (eGFR) of > 30ml/min. according to the MDRD Study equation at the time of admission.
- Female patients of child bearing potential must have a negative urine pregnancy test to be eligible.
Key exclusion criteria (10 listed)
- Acute coronary syndrome
- Patients with a baseline eGFR < 30 ml/min according to the MDRD equation.
- Baseline potassium serum concentration 5.3 meq/L
- Requirement for intravenous pressors
- 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 |
|---|---|---|
| SpironolactoneAlso: aldactone, potassium-sparing diureticsAdministration of spironolactone 25-50mg orally twice daily for two days and subsequently titrated upto 100mg twice daily with daily serum potassium monitoring. Spironolactone will continue until patient is euvolemic and appropriate for discharge. Titration of loop diuretics in this arm will not be escalated. | Drug | High dose spironolactone |
Primary outcome
Efficacy of adjunctive high-dose Spironolactone on weight loss.
Time frame: 7 days
Weight will be tracked from enrollment to 7 days or when patient reaches euvolemia for all patients, whichever occurs first.
3 secondary outcomes
Efficacy of adjunctive high-dose Spironolactone on dyspnea.
Time frame: 7 days
Risk of hyperkalemia and renal dysfunction with use of adjunctive high-dose Spironolactone.
Time frame: 7 days
Length of hospitalization
Time frame: 7 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 20 Apr 2016.
- Background: PubMed 22179539Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
- Background: PubMed 10451464Schrier RW, Abraham WT. Hormones and hemodynamics in heart failure. N Engl J Med. 1999 Aug 19;341(8):577-85. doi: 10.1056/NEJM199908193410806. No abstract available.
- Background: PubMed 16843085Schrier RW. Water and sodium retention in edematous disorders: role of vasopressin and aldosterone. Am J Med. 2006 Jul;119(7 Suppl 1):S47-53. doi: 10.1016/j.amjmed.2006.05.007.
- Background: PubMed 17568020Schrier RW. Decreased effective blood volume in edematous disorders: what does this mean? J Am Soc Nephrol. 2007 Jul;18(7):2028-31. doi: 10.1681/ASN.2006111302. Epub 2007 Jun 13.
- Background: PubMed 2220602Hirsch AT, Pinto YM, Schunkert H, Dzau VJ. Potential role of the tissue renin-angiotensin system in the pathophysiology of congestive heart failure. Am J Cardiol. 1990 Oct 2;66(11):22D-30D; discussion 30D-32D. doi: 10.1016/0002-9149(90)90473-e.
- Background: PubMed 4398836Schrier RW, De Wardener HE. Tubular reabsorption of sodium ion: influence of factors other than aldosterone and glomerular filtration rate. 2. N Engl J Med. 1971 Dec 2;285(23):1292-303. doi: 10.1056/NEJM197112022852305. No abstract available.
- Background: PubMed 15846257Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
- Background: PubMed 16160202Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.
- Background: PubMed 6147109Francis GS, Goldsmith SR, Levine TB, Olivari MT, Cohn JN. The neurohumoral axis in congestive heart failure. Ann Intern Med. 1984 Sep;101(3):370-7. doi: 10.7326/0003-4819-101-3-370.
- Background: PubMed 3541995Bayliss J, Norell M, Canepa-Anson R, Sutton G, Poole-Wilson P. Untreated heart failure: clinical and neuroendocrine effects of introducing diuretics. Br Heart J. 1987 Jan;57(1):17-22. doi: 10.1136/hrt.57.1.17.
- Background: PubMed 7607716He XR, Greenberg SG, Briggs JP, Schnermann J. Effects of furosemide and verapamil on the NaCl dependency of macula densa-mediated renin secretion. Hypertension. 1995 Jul;26(1):137-42. doi: 10.1161/01.hyp.26.1.137.
- Background: PubMed 11805380Ellison DH. Diuretic therapy and resistance in congestive heart failure. Cardiology. 2001;96(3-4):132-43. doi: 10.1159/000047397.
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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.
Marvin H Eng, M.D. principal investigator
University of Texas Heatlh 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?
A Phase 4 study testing Spironolactone in people with 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 5 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: withdrawn, as of the sponsor's last update on 20 Apr 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy of adjunctive high-dose Spironolactone on weight loss. (time frame: 7 days). 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 NCT02429388, which also lists 28 linked publications.
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 20 Apr 2016.