Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction

Launched by UPPSALA UNIVERSITY · Sep 14, 2016

Keywords

ClinConnect Summary

The SPIRRIT trial is studying whether adding a medication called spironolactone to standard heart failure care can help patients with heart failure that preserves its pumping ability (known as heart failure with preserved ejection fraction, or HFPEF). This trial is particularly important because many people suffer from HFPEF, and currently, there are no approved treatments. Participants will be randomly assigned to receive either spironolactone along with their usual care or just their usual care alone. The main goal is to see if this combination can lower the risk of serious heart-related problems or hospital stays due to heart failure.

To be eligible for this trial, participants must be at least 50 years old and have been diagnosed with stable heart failure, which means they have symptoms but are not in acute distress. They also need to have certain blood test results that indicate elevated levels of a protein related to heart failure. Participants can expect to be part of a long-term study that will involve regular check-ups and monitoring over several years. This trial is open to both men and women, and your doctor can help determine if you meet the criteria to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent
• • Age ≥50 years
• • Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator
• • Left ventricular ejection fraction (LVEF) ≥40% recorded in last 12 months (stratified to max 2/3rd in either 40-49% or ≥50% group)
• * Elevated natriuretic peptide levels, as defined by any of the following:
• • 1. most recent NT-proBNP \>300 ng/L (or BNP\>100 pg/mL) in sinus rhythm at time of blood sampling; adjustments may be made for BMI according to table 3.
• • 2. most recent NT-proBNP \>750 ng/L (or BNP \>250 pg/mL) in atrial fibrillation at time of blood sampling; adjustments may be made for BMI according to table 3.
• • 3. NT-proBNP \>1200 ng/L (or BNP \>400 pg/mL) within the last 12 months even if most recent value is lower.
• • Regular use of loop diuretics, defined as daily or most days of the week
• • NYHA Class II-IV
• Exclusion Criteria:
• • Previously enrolled in this study
• • Known Ejection Fraction \< 40% ever
• • Current absolute indication or contraindication for MRA (mineral receptor antagonist) in judgement of Investigator
• • Known chronic liver disease
• * Probable alternative explanations for symptoms:
• • Known primary cardiomyopathy (hypertrophic, constrictive, restrictive, infiltrative, congenital)
• • Primary hemodynamically significant valve disease
• • Right-sided HF not due to left-sided HF
• • Significant chronic pulmonary disease defined by Investigator or by requirement for home O2
• • Symptomatic anemia, defined as Hemoglobin \< 10 g/dL (100 g/L )
• • Heart transplant or LVAD (left ventricular assist device) recipient
• • Presence of cardiac resynchronization therapy (CRT) device
• • Systolic blood pressure \<90 or \>160 mmHg
• • K (potassium) \>5.0 mmol/L
• • eGFR (estimated glomerular filtration rate) by MDRD (Modification of Diet in Renal Disease) \< 30 ml/min/1.73m2 or creatinine \> 2.5 mg/dL (221 µmol/L )
• • Current lithium use
• • Current dialysis
• • Actual or potential for pregnancy
• • Participation in another interventional clinical trial where a mineralocorticoid receptor antagonist is studied
• • Any condition that in the opinion of the Investigator may interfere with adherence to trial protocol