Testing spironolactone for heart failure with preserved ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of spironolactone in patients with heart failure with preserved ejection fraction (HFPEF) compared to standard care alone. It involves a registry-randomized design where participants will be assigned to receive either spironolactone plus usual care or usual care alone. The primary outcome will focus on cardiovascular mortality and hospitalizations due to heart failure. The study will include patients from the Swedish Heart Failure Registry and various sites in the US, ensuring a diverse population for analysis.

Why it matters

Who can join: the full rules

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

Where it's running

• Falu lasarett
  Falun, Sweden Recruiting
• Vårdcentralen Centrum i Flen
  Flen, Sweden Recruiting
• Sahgrenska University Hospital Östra
  Gothenburg, Sweden Recruiting
• Sahlgrenska Universitetssjukhuset
  Gothenburg, Sweden Recruiting
• Hemse Vårdcentral
  Hemse, Sweden Recruiting
• Karolinska University Hospital
  Huddinge, Sweden Recruiting

+28 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Lars H Lund, MD, PhD — Karolinska Institutet
• Study coordinator: Anna Gustavsson (SWE)
• Email: anna.gustavsson@ucr.uu.se
• Phone: +46186110181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.