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Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction SPIRRIT-HFpEF
EU CTIS ID: 2024-517448-79-00
What this study is testing
The primary objective is to assess whether the initiation of spironolactone or eplerenone plus standard of care compared to standard of care alone reduces the incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death in HFpEF, studied with the pragmatic Registry-based Randomized Clinical Trial (RRCT) methodology.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent
- Age ≥50 years
- Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator. Patients may be enrolled as an outpatient or in-hospital at, or close to, the time of hospital discharge
- Most recent left ventricular ejection fraction (LVEF) ≥40%
- Elevated natriuretic peptide levels as defined by any of the following: a. 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. b. 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. c. 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
You likely can't join if
- Previously enrolled in this study
- eGFR by MDRD < 30 ml/min/1.73m2 (most recent, not older than 30 days)
- Current dialysis
- Current lithium use
- Actual or potential for pregnancy
- Participation in another interventional clinical trial where a mineralocorticoid receptor antagonist is studied. Co-enrollment in trials and observational studies of other medical and device interventions is permitted
See the full eligibility criteria
- Written informed consent
- Age ≥50 years
- Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator. Patients may be enrolled as an outpatient or in-hospital at, or close to, the time of hospital discharge
- Most recent left ventricular ejection fraction (LVEF) ≥40%
- Elevated natriuretic peptide levels as defined by any of the following: a. 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. b. 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. c. 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
- Previously enrolled in this study
- eGFR by MDRD < 30 ml/min/1.73m2 (most recent, not older than 30 days)
- Current dialysis
- Current lithium use
- Actual or potential for pregnancy
- Participation in another interventional clinical trial where a mineralocorticoid receptor antagonist is studied. Co-enrollment in trials and observational studies of other medical and device interventions is permitted
- Not suitable in the opinion of the Investigator due to severe or terminal comorbidity with poor prognosis, or characteristics that may interfere with adherence to trial protocol
- Known EF <40% ever
- Current absolute indication or contraindication for MRA in judgement of Investigator. In the absence of absolute indication, patients currently treated with an MRA may have the MRA discontinued and then included in the trial according to investigator judgement
- Known chronic liver disease
- Probable alternative explanations for symptoms such as: (a) Known primary cardiomyopathy that is hypertrophic with obstruction, constrictive, restrictive, infiltrative, or congenital (hypertrophic without current obstruction and other primary cardiomyopathies are allowed) (b) Primary valve disease (to exclude a patient, the valve disease must be primary AND the primary cause of the symptoms) (c) Significant chronic pulmonary disease requiring home O2 (d) Symptomatic anemia (hemoglobin is <10 g/dL (100 g/L) and this is the likely cause of the symptoms) (e) Right-sided HF not due to left sided HF
- Heart transplant or LVAD recipient
- Presence of cardiac resynchronization therapy (CRT) device
- Systolic blood pressure <90 or >160 mm Hg at baseline (assessments documented in Medical Records within 30 days) *. *) Blood pressure taken by the patient themselves at home is accepted if no other data is documented within 30 days. The home measurement needs to be noted in Medical Records
- K >5.0 mmol/L (non-hemolysis sample**; most recent, not older than 30 days). **) All K values in the trial refer to non-hemolysis samples. If hemolysis, blood test needs to be repeated.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.