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RECRUITING

NCT02901184

PHASE3

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

Sponsor: Uppsala University

View on ClinicalTrials.gov

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 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: 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.

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

Key Details

Gender

All

Age Range

50 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2017-11-23

Completion Date

2026-12

Last Updated

2024-10-22

Healthy Volunteers

Conditions

Heart Failure With Preserved Ejection Fraction

Interventions

DRUG

Spironolactone

Treatment with Spironolactone tablets on top of standard care

OTHER

Standard care

Standard care does not involve Spironolactone

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

Locations (78)

Advanced Cardiovascular LLC

Alexander City, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner - University Medical Group

Tucson, Arizona, United States

MedStar Cardiovascular Research Network

Washington D.C., District of Columbia, United States

Howard University Hospital

Washington D.C., District of Columbia, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Wellstar Health System, Inc.

Marietta, Georgia, United States

Queens Medical Center

Honolulu, Hawaii, United States

Fox Valley Clinical Research Center, LLC

Aurora, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

St. Vincent Medical Group

Indianapolis, Indiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Shady Grove Adventist Hospital

Rockville, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Pentucket Medical Associates

Haverhill, Massachusetts, United States

Charles River Medical Associates

Natick, Massachusetts, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Ascension Genesys Hospital

Grand Blanc, Michigan, United States

The Heart House Haddon Heights

Haddon Heights, New Jersey, United States

Rutgers University - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

University at Buffalo

Buffalo, New York, United States

Northwell Health - Manhasset

Manhasset, New York, United States

Mount Sinai Medical Cente

New York, New York, United States

Mid Carolina Cardiology Research

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Stern Cardiovascular Center

Germantown, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Miami Hospital

Miami, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Angereds närsjukhus

Angered, Sweden

Hälsostaden Ängelholms sjukhus

Ängelholm, Sweden

Falu lasarett

Falun, Sweden

Närsjukvården i Finspång

Finspång, Sweden

Vårdcentralen Centrum i Flen

Flen, Sweden

Sahgrenska University Hospital Östra

Gothenburg, Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Hemse Vårdcentral

Hemse, Sweden

Karolinska University Hospital

Huddinge, Sweden

Länssjukhuset Ryhov

Jönköping, Sweden

Blekingesjukhuset

Karlskrona, Sweden

Hjärtmottagningen, Centralsjukhuset

Karlstad, Sweden

Västmanlands sjukhus Köping

Köping, Sweden

Centralsjukhuset Kristianstad

Kristianstad, Sweden

Lasarettet i Landskrona

Landskrona, Sweden

Skaraborgs sjukhus i Lidköping

Lidköping, Sweden

Linköpings Universitetssjukhus

Linköping, Sweden

VO Akut- och internmedicin, Skånes Universitetssjukhus

Lund, Sweden

Capio Citykliniken

Lund, Sweden

FO Kranskärl/Svikt, Skånes Universitetssjukhus

Lund, Sweden

Hjärtavdelningen, Skånes Universitetssjukhus

Malmo, Sweden

Kliniska forskningsenheten Skånes Universitetssjukhus

Malmo, Sweden

Mariefreds Vårdcentral

Mariefred, Sweden

Sahlgrenska University Hospital Mölndal

Mölndal, Sweden

Kardiologikliniken, Vrinnevisjukhuset

Norrköping, Sweden

Oskarshamns sjukhus

Oskarshamn, Sweden

Örebro University Hospital

Örebro, Sweden

Skellefteå lasarett

Skellefteå, Sweden

Karolinska University Hospital

Solna, Sweden

Södertälje sjukhus

Södertälje, Sweden

VO Kardiologi, Södersjukhuset AB

Stockholm, Sweden

Capio S:t Görans sjukhus AB

Stockholm, Sweden

Danderyds sjukhus AB

Stockholm, Sweden

Länssjukhuset Sundsvall-Härnösand

Sundsvall, Sweden

Sundsvalls Vårdcentral

Sundsvall, Sweden

Uppsala University Hospital, Cardiology dept

Uppsala, Sweden

Uppsala University Hospital, Internal Medicine dept

Uppsala, Sweden

Medicinkliniken, Hallands sjukhus

Varberg, Sweden

Västmanlands sjukhus Västerås

Västerås, Sweden

Västerviks sjukhus

Västervik, Sweden

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (78)