The RALES study demonstrated that treatment with low dose spironolactone was associated with improved survival, reduced hospitalisations, improved NYHA class when added to standard therapy in patients with severe (NYHA class III or IV) chronic heart failure.

This advice applies to monitoring of pharmacotherapy in clinically stable patients; it does NOT apply to patients with intercurrent acute illness.

MRA such as spironolactone or eplerenone SHOULD be offered in addition to an ACE inhibitor (or ARB/ARNI) and beta-blocker, to people who have heart failure with reduced ejection fraction, EF<40% if they continue to have symptoms of heart failure.

For HFmrEF, spironolactone may be considered as additional therapy to reduce mortality and hospitalisation.

Consider referral prior to initiation:

• Hyponatraemia (Na<135mmol/L)

• Symptomatic hypotension or severe asymptomatic hypotension (systolic BP<90mmHg)

• Significant renal dysfunction/renovascular disease e.g. creatinine > 150 μmol/L or eGFR<50ml/min or hyperkalemia (>5.0mmol/L)

Check pre-treatment blood chemistry (serum creatinine, urea, potassium, sodium, eGFR and liver function tests) and blood pressure.

Use the immediate pre-treatment serum creatinine concentration as the baseline

• Initiate 25mg once daily (For elderly patients use either 12.5mg daily or 25mg on alternate days).

• Check blood chemistry; serum creatinine, urea, potassium, sodium) and blood pressure before and between one and two weeks after starting therapy or making a dose adjustment

• Once the target, or maximum tolerated dose is reached, monitor treatment monthly for 3 months and then at least every 6 months and at any time the patient becomes acutely unwell

• For those patients started on a lower dose if blood chemistry and BP are within normal ranges at 4 weeks titrate to 25mg daily.

• Doses of 50mg daily may be advised by a specialist if heart failure symptoms deteriorate and the patients K+ level permits.

Sodium/water depletion and/or hypovolaemia

• Consider a reduction in the concomitant diuretic dose, e.g., bumetanide or furosemide

• Measure blood chemistry

• Consider reducing the dose or stopping spironolactone

Symptomatic hypotension

• Measure blood chemistry

• Assess fluid intake

• Consider a reduction in the diuretic dose or omit a couple of doses of diuretic

• Advise about avoiding abrupt postural changes

• Review in 1-2 days. If symptoms persist or are severe, seek specialist advice

GI upset

• Reduce dose or stop therapy

Hyponatraemia

• Na< 130mmol/L, stop spironolactone and seek advice

Gynaecomastia

• Stop spironolactone - usually reversible on cessation of therapy

• Review need for digoxin (if co-prescribed) as may also cause gynaecomastia

• Eplerenone may be considered as an alternative to spironolactone, under specialist supervision, for patients with severe HFrEF, where spironolactone is indicated but has not been tolerated usually due to the development of gynaecomastia.

Worsening renal function

Spironolactone is a disease modifying drug in patients with HFrEF so it improves patient outcomes. The risk of stopping or reducing dose is, in general, likely to be of greater detriment to a patient’s prognosis than a modest increase in serum creatinine, or mild hyperkalaemia.

These guidelines are generally for management of CKD

An increase in urea, creatinine and K+ is to be expected after initiation/titration of spironolactone. If the increase is small and asymptomatic, no action is necessary. Please see the table below for recommended actions.

Please ensure patient has a genuine AKI (rapidly deteriorating renal function) before prognostic medication is discontinued.

If prognostic medication is stopped due to AKI/acutely unwell patient, please consider restarting if renal function recovers. Please liaise with the heart failure team for further advice.

• Treatment is given to improve symptoms, prevent worsening of heart failure and to prolong life.

• Symptom improvement occurs within a few weeks to a few months of starting treatment.

• Spironolactone should be taken with food

• Avoid salt substitutes (LO-SALT) and over the counter cystitis remedies high in K+.

• Avoid NSAIDs (including over the counter and topical NSAIDs)

• In the case of dehydration, diarrhoea or vomiting, stop the spironolactone immediately and contact your GP.

See BNF for full list of interactions

Chronic Heart Failure in Adults: Diagnosis and Management. NICE clinical Guideline NG106. Issued September 2018. Available at: www.nice.org.uk/guidance/NG106

•Summary of product characteristics for Aldactone. Available online at www.medicines.org.uk

•British National Formulary

With thanks to the Sussex Heart Network, from whom these guidelines were adapted Changes in kidney function and serum potassium during ACEI/ARB/diuretic treatment in Primary Care. A position statement from Think Kidneys, the Renal Association and the British Society for Heart Failure. October 2017 https://www.thinkkidneys.nhs.uk/aki/wp-content/uploads/sites/2/2017/10/Changes-in-Kidney-Function-FINAL.pdf Accessed 1/5/18.

Theresa A McDonagh et al, 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC, European Heart Journal, Volume 42, Issue 36, 21 September 2021, Pages 3599–3726, https://doi.org/10.1093/eurheartj/ehab368

This guideline has been registered with the Trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt, contact a senior colleague or expert. Caution is advised when using guidelines after the review date.
This guideline is for use in Frimley Health NHS Foundation Trust hospitals only. Any use outside this location will not be supported by the Trust and will be at the risk of the individual using it.

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