Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
Spironolactone In The Treatment of Heart Failure- A Double-blind, Randomized, Placebo-controlled, Parallel Group Interventional Phase III Study to Determine Efficacy and Safety of Spironolactone on the Composite Endpoint of Recurrent Heart Failure Hospitalizations and Cardiovascular Death in Patients With Heart Failure With Mid-range or Preserved Ejection Fraction
The purpose of this study is to determine whether the treatment of patients with HFmrEF and HFpEF at high risk of cardiovascular events with the mineralocorticoid receptor antagonist (MRA) spironolactone reduces a composite of recurrent heart failure hospitalizations and cardiovascular mortality.
The primary objective of the SPIRIT-HF study is to compare Spironolactone to Placebo in reducing the rate of the composite endpoint of recurrent heart failure hospitalizations and cardiovascular (CV) death in symptomatic HF patients (NYHA II-IV) with mid-range (LVEF 40- 49 %) or preserved (LVEF ≥ 50 %) ejection fraction. The efficacy and safety of mineralocorticoid receptor antagonist (MRA) in reducing the risk of death and hospitalizations has been proven with two separate substances (Spironolactone; RALES 1999 and Eplerenone; EMPHASIS 2011) in symptomatic heart failure patients with reduced left- ventricular ejection fraction (HFrEF). In 2013 the TOPCAT investigators tried to proof similar efficacy in patients with heart failure and preserved ejection fraction (≥ 45%). Because of regional variations in the enrollment process and difficulties regarding drug adherence the trial revealed neutral findings but the substance spironolactone was still able to show its potential benefit in the American cohort. Hence, the investigators see a strong rationale for testing a mineralocorticoid receptor blocker in patients suffering from heart failure with mid-range or preserved left ventricular ejection fraction. Intervention: Mineralocorticoid receptor blocker Spironolactone in tablet form taken daily. Starting dosage will be 25 mg OD with dosage escalation to 50 mg OD within 4 weeks if kidney function at VR was > 30 mL/min/m2 and potassium < 4.5 mmol/L. Spironolactone is not approved for the treatment of HFmrEF and HFpEF. Matching placebo in tablet form taken daily with dosage escalation rules in accordance with dosage of the study drug Spironolactone. Visits: Screening (VScr), Visit of Randomization (VR), V1 Safety Visit (1 week), V2 (4 weeks), V2S Safety Visit (5 week), V3 (4 months), V4 (8 months), V5 (12 months), V6 (18 months), V7 (24 months), V8 (30 months), V9 (36 months), V10 (42 months), V11/EOT (48 months); VXS (1 week after Visit X). Individual intervention duration with spironolactone or placebo will be continued until the overall expected event rate is reached or until withdrawal of informed consent. Based on previous HF trials the investigators calculate a mean follow-up duration of 3 years (range 2-4 years) depending on the individual inclusion date. Duration of follow-up will be event-rate based, with an expected overall study duration of 60 months. With an anticipated recruitment phase of 24 months; this will result in a maximum follow-up of 48 months and an average follow-up per patient of 36 months assuming a constant recruitment rate. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05839730 -
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT05095688 -
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF
|
||
Recruiting |
NCT06379152 -
Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT05676684 -
Dapagliflozin, Spironolactone or Both for HFpEF
|
Phase 2/Phase 3 | |
Recruiting |
NCT04153136 -
Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)
|
Phase 2 | |
Recruiting |
NCT06114498 -
Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT05715697 -
Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT04745013 -
PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart
|
N/A | |
Completed |
NCT05586828 -
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
|
||
Completed |
NCT05126836 -
Cilostazol for HFpEF
|
Phase 2 | |
Recruiting |
NCT04594499 -
The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
|
||
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
|
||
Completed |
NCT04535726 -
The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity
|
||
Recruiting |
NCT03550235 -
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
|
||
Completed |
NCT04633460 -
Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
|
Phase 2 | |
Completed |
NCT06228807 -
Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF
|
||
Active, not recruiting |
NCT05284617 -
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
|
Phase 2 | |
Recruiting |
NCT05562063 -
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
|
Phase 4 | |
Recruiting |
NCT06027307 -
Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
|
Phase 3 | |
Recruiting |
NCT05582044 -
Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
|
N/A |