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Heart Failure With Preserved Ejection FractionPhase 3SPIRRITNCT02901184

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

A Phase 3 study testing Spironolactone in people with Heart Failure With Preserved Ejection Fraction, run by Uppsala University at 78 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFPEF, but it is generic and will not be studied by… Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
Spironolactone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
78 sitesin 2 countries
Study dates
23 Nov 2017to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
Show all 10Show fewer
  • 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.
  • 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

Who cannot join

  • 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)
Show all 20Show fewer
  • 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

Trial locations and contacts

78 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Anna Gustavsson (SWE) contact

+46186110181

anna.gustavsson@ucr.uu.se

Will Simmons (US) contact

919-668-0541

will.simmons@duke.edu

78 sites in 2 countries

Sweden40 sites, 29 recruiting

  • Hälsostaden Ängelholms sjukhus

    Ängelholm

    Terminated

  • Angereds närsjukhus

    Angered

    Terminated

  • Falu lasarett

    Falun

    Fahed Sulaiman

    Recruiting

  • Närsjukvården i Finspång

    Finspång

    Terminated

  • Vårdcentralen Centrum i Flen

    Flen

    Kaj Possler

    Recruiting

  • Sahgrenska University Hospital Östra

    Gothenburg

    Mikael Fu

    Mikael Fu

    Recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg

    Charlotta Ljungman

    Recruiting

  • Hemse Vårdcentral

    Hemse

    Ann Hovland-Tånneryd

    Recruiting

  • Karolinska University Hospital

    Huddinge

    Lars H Lund

    Lars H Lund

    Recruiting

  • Länssjukhuset Ryhov

    Jönköping, 55185

    Patric Karlström

    Recruiting

  • Blekingesjukhuset

    Karlskrona, 37185

    Active, not recruiting

  • Hjärtmottagningen, Centralsjukhuset

    Karlstad, 65230

    Edit Floderer

    Recruiting

  • Västmanlands sjukhus Köping

    Köping

    Emöke Fodor

    Recruiting

  • Centralsjukhuset Kristianstad

    Kristianstad

    Terminated

  • Lasarettet i Landskrona

    Landskrona

    Fredrik Kymle

    Recruiting

  • Skaraborgs sjukhus i Lidköping

    Lidköping

    Magnus Peterson

    Recruiting

  • Linköpings Universitetssjukhus

    Linköping, 58185

    Henriette van der Wal

    Recruiting

  • VO Akut- och internmedicin, Skånes Universitetssjukhus

    Lund, 22185

    Terminated

  • Capio Citykliniken

    Lund

    Carl-Johan Lindholm

    Recruiting

  • FO Kranskärl/Svikt, Skånes Universitetssjukhus

    Lund

    Grunde Gjesdal

    Recruiting

  • Hjärtavdelningen, Skånes Universitetssjukhus

    Malmö, 20502

    Terminated

  • Kliniska forskningsenheten Skånes Universitetssjukhus

    Malmö

    Patrik Svenson

    Recruiting

  • Mariefreds Vårdcentral

    Mariefred

    Tobias Reitberger

    Tobias Reitberger

    Recruiting

  • Sahlgrenska University Hospital Mölndal

    Mölndal

    Pär Parén

    Pär Parén

    Recruiting

  • Kardiologikliniken, Vrinnevisjukhuset

    Norrköping, 60182

    Dimitros Ftakas

    Recruiting

  • Örebro University Hospital

    Örebro

    Barna Szabó

    Barna Szabó

    Recruiting

  • Oskarshamns sjukhus

    Oskarshamn

    Active, not recruiting

  • Skellefteå lasarett

    Skellefteå

    Lars Gustafsson

    Recruiting

  • Södertälje sjukhus

    Södertälje

    Terminated

  • Karolinska University Hospital

    Solna

    Lars H Lund

    Lars H Lund

    Recruiting

  • VO Kardiologi, Södersjukhuset AB

    Stockholm, 11883

    Carin Corovic Cabrera

    Recruiting

  • Capio S:t Görans sjukhus AB

    Stockholm

    Majid Jourak

    Recruiting

  • Danderyds sjukhus AB

    Stockholm

    Jonas Spaak

    Recruiting

  • Länssjukhuset Sundsvall-Härnösand

    Sundsvall

    Mohammad Kavianipour

    Recruiting

  • Sundsvalls Vårdcentral

    Sundsvall

    Terminated

  • Uppsala University Hospital, Cardiology dept

    Uppsala

    Tymon Pol, MD, Phd

    Recruiting

  • Uppsala University Hospital, Internal Medicine dept

    Uppsala

    Michael Dimberg

    Recruiting

  • Medicinkliniken, Hallands sjukhus

    Varberg, 43281

    Petru Tutuainu

    Recruiting

  • Västmanlands sjukhus Västerås

    Västerås

    Ingmar Lönnberg

    Ingmar Lönnberg

    Recruiting

  • Västerviks sjukhus

    Västervik

    Active, not recruiting

Other trials in Sweden

United States38 sites

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico, 87131

    Terminated

  • Advanced Cardiovascular LLC

    Alexander City, Alabama, 35010

    Terminated

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

    Terminated

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

    Terminated

  • Fox Valley Clinical Research Center, LLC

    Aurora, Illinois, 60506-1400

    Terminated

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Terminated

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Terminated

  • University at Buffalo

    Buffalo, New York, 14203

    Terminated

  • Mid Carolina Cardiology Research

    Charlotte, North Carolina, 28204

    Terminated

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Terminated

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267-0542

    Terminated

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Terminated

  • Duke University

    Durham, North Carolina, 27710-4000

    Terminated

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

    Terminated

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Terminated

  • Stern Cardiovascular Center

    Germantown, Tennessee, 38138

    Terminated

  • Ascension Genesys Hospital

    Grand Blanc, Michigan, 48439

    Terminated

  • The Heart House Haddon Heights

    Haddon Heights, New Jersey, 08035

    Terminated

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

    Terminated

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Terminated

  • Queens Medical Center

    Honolulu, Hawaii, 96813

    Terminated

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46260

    Terminated

  • Northwell Health - Manhasset

    Manhasset, New York, 11030

    Terminated

  • Wellstar Health System, Inc.

    Marietta, Georgia, 30060

    Terminated

  • University of Miami Hospital

    Miami, Texas, 33136

    Terminated

  • Charles River Medical Associates

    Natick, Massachusetts, 01760

    Terminated

  • Rutgers University - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

    Terminated

  • Ochsner Medical Center

    New Orleans, Louisiana, 85724

    Terminated

  • Mount Sinai Medical Cente

    New York, New York, 10029

    Terminated

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

    Terminated

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

    Terminated

  • Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Terminated

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Terminated

  • Shady Grove Adventist Hospital

    Rockville, Maryland, 20850

    Terminated

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Terminated

  • Banner - University Medical Group

    Tucson, Arizona, 85724

    Terminated

  • MedStar Cardiovascular Research Network

    Washington D.C., District of Columbia, 20010

    Terminated

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060

    Terminated

Other trials in United States

About this study

Official title: Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction, SPIRRIT-HFPEF

Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFPEF, but it is generic and will not be studied by industry.

SPIRRIT is a unique Registry-Randomized Clinical Trial (RRCT) that will test the hypothesis that spironolactone plus standard of care compared to standard of care alone reduces the composite of CV mortality and HF hospitalization as follows:

Read more

Population: HFPEF patients in the Swedish Heart Failure Registry and HFPEF patients in US. HFPEF defined as symptoms/signs of HF, elevated NTproBNP (B-type Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF>=40%. Intervention and control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual care alone.

Outcome: Primary outcome cardiovascular death or time to HF hospitalization. Secondary outcomes include hospitalization for various causes, adverse events and treatment adherence. In Sweden outcomes are obtained automatically by linking with the Population, Patient and Drug Dispensed Registries. In the US, outcomes will be reported by sites and supplemented by data from a call center. The trial is event-driven with enrollment 7 years and study duration 9 years. For the primary outcome (CV Death or first HF hospitalization) with an event target of 721 events the sample size requires 1985 patients conservatively rounded to approximately 2000 patients.

Being tested
Spironolactone, Standard care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpironolactoneDrug

    Treatment with Spironolactone tablets on top of standard care

  • Standard careOther

    Standard care does not involve Spironolactone

Study groups in NCT02901184
Study groupRoleWhat they receive
Spironolactone treatmentActive comparatorSpironolactone will be prescribed by the Investigator and filled by patient at conventional pharmacies as 25 mg tablets. The treatment will be on top of standard care. Initial dose is 25 mg/day, which will be increased to target dose 50 mg/day if tolerated. Eplerenone can be prescribed if spironolactone is not tolerated.
Receives: Drug: Spironolactone
Standard care alonePlacebo comparatorPatients in the control arm will get the standard care alone
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death

    Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

Secondary outcomes (8)

  1. Time to CV Death or first HF hospitalization

    Sweden: Information on Death from the Swedish Causes of death registry US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

  2. Time to CV Death

    Sweden: Information on Death from the Swedish Causes of death registry US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

  3. Incidence rate for total HF hospitalizations

    Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry.

    US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

  4. Time to HF hospitalizations

    Sweden: Information on information on hospitalization collected from Swedish Patient Registry.

    US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

  5. Time to all-cause mortality

    Sweden: Information on Death from the Swedish Causes of death registry. US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start

  6. Incidence rate for all-cause hospitalizations

    Sweden: Information on information on hospitalization collected from Swedish Patient Registry.

    US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

  7. Time to all-cause hospitalizations

    Sweden: Information on information on hospitalization collected from Swedish Patient Registry.

    US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

  8. Incidence rate for all-cause hospitalizations or all-cause mortality

    Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry.

    US: Collected in eCRF or via call center interview

    Measured: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2016 (estimated)
  2. Study start23 Nov 2017
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02901184
Sponsor's protocol ID
U-2015-030
Other IDs
U01HL134679-01, U01HL134694-02
Acronym
SPIRRIT
Status last verified
Oct 2024
First submitted
9 Sep 2016
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Spironolactone in people with Heart Failure With Preserved Ejection Fraction, run by Uppsala University at 78 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Sweden, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Gustavsson (SWE) (+46186110181, anna.gustavsson@ucr.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death (time frame: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02901184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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