Heart Failure Acute Clinical Trial
Official title:
Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure
This is a prospective, single-center, open-label and randomized trial for evaluation of the effect of a 5-day administration of high doses of spironolactone (≥100mg daily) on diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with acute decompensated heart failure (ADHF). Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of care (SOC) in management of heart failure (HF) patients. However, recommended doses of MRAs (up to 50mg daily) have any impact on signs and symptoms of volume overload. Therefore, the proposed study will aim to show the impact of high doses of spironolactone to improve diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with ADHF.
Congestion represents a hallmark feature of ADHF, which is present in more than 90% of patients hospitalized for this diagnosis. Intravenous loop diuretics are the mainstay of treatment. Nonetheless, nearly half of the patients who are hospitalized for AdHF continue to have residual symptoms and sign of congestion at time of discharge. Various pharmacological and non-pharmacological interventions have been proposed over the past years as potential means for relieving congestion in hospitalized ADHF patients. However, their efficacy has not been shown. Given that hyperaldosteronism is a key feature in HF, the hypothesis that administration of high doses of spironolactone can potentiate the natriuretic effects of loop diuretics and relieve congestion in the setting of ADHF has been raised. According to the most recent guidelines spironolactone can be considered in combination with loop diuretic in patients with resistant edema or insufficient symptomatic response. However, spironolactone at a dose of 100 mg daily has failed to increase diuresis in patients with ADHF. The present study will assess the effect of high per os doses of spironolactone (≥100mg) on top of SOC treatment compared with SOC treatment alone on diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with ADHF. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03288701 -
Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure
|
N/A | |
Enrolling by invitation |
NCT06036914 -
A Study of Ultra High Dose Diuretics to Treat Heart Failure
|
Phase 2 | |
Completed |
NCT03387813 -
Hemodynamic-GUIDEd Management of Heart Failure
|
N/A | |
Completed |
NCT03203629 -
Heart Sounds Registry
|
||
Completed |
NCT04281849 -
Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program
|
N/A | |
Not yet recruiting |
NCT04403659 -
Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study
|
N/A | |
Completed |
NCT03657459 -
Danger Signs in Heart Failure- Effects of Video Education
|
N/A | |
Completed |
NCT03722069 -
Dietary Sodium Intake in Acute Heart Failure
|
N/A | |
Completed |
NCT03804827 -
Sleep Disordered Breathing in Acute Congestive Heart Failure
|
||
Completed |
NCT06468007 -
Comparative Effects of Methylprednisolone and Prednisolone on the Risk of Acute Decompensated Heart Failure - An Emulated Target Trial
|
||
Completed |
NCT04145635 -
The Aortix CRS Pilot Study
|
N/A | |
Recruiting |
NCT04611594 -
Fluid Restriction in Patients With Heart Failure
|
N/A | |
Terminated |
NCT04643184 -
Follow-up Strategies for Fragile Patients With Decompensated Heart Failure
|
N/A | |
Completed |
NCT03200860 -
Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure
|
Phase 2 | |
Terminated |
NCT05751772 -
Improving Knowledge in Heart Failure Inpatient With Therapeutic Education
|
N/A | |
Recruiting |
NCT03586336 -
Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure
|
N/A | |
Recruiting |
NCT03103932 -
Biomarker Guided Discharge of Heart Failure Patients
|
N/A | |
Recruiting |
NCT05498584 -
Targeting LOXL2 and Cardiac Fibrosis for Post-acute Heart Failure Treatment- A Prospective Study
|
||
Recruiting |
NCT05677100 -
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
|
N/A | |
Terminated |
NCT04095416 -
Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure
|
N/A |