AzTrials
AzTrials

Ventricular ArrhythmiasPhase 4SPIRITNCT04495712

Antiarrhythmic Effects of Spironolactone in Patients With ICDs

A Phase 4 study testing spironolactone in people with Ventricular Arrhythmias, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators. Half the patients in the study will get spironolactone and half will get a placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Arrhythmias
What is being tested?
spironolactone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteUnited States
Study dates
28 Jul 2004to 28 May 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Patients were considered eligible for enrollment only if they had received
  • an ICD therapy, either a shock or antitachycardia pacing (ATP),
  • VT/VF in the previous 2 years or
  • received an ICD for secondary prevention of sustained VT/VF in the previous 6 months.

Who cannot join

  • -Important exclusion criteria were
  • an indication for spironolactone based on the RALES trial (EF of <35% and -New York Heart Association (NYHA) class III or IV),
  • unstable angina,
  • primary hepatic failure,
  • known intolerance to spironolactone,
  • a serum creatinine concentration of >2.5 mg/dL,
  • a serum potassium concentration of >5.0 mmol/L, and
  • a life expectancy of <2 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239

Other trials in United States

About this study

This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators. Half the patients in the study will get spironolactone and half will get a placebo. Neither the patients or their providers will know if they are getting spironolactone or placebo.

Read the detailed description

Objectives: This study is designed to determine whether spironolactone at a dose of 25 mg per day in patients with implanted cardioverter defibrillators (ICD) will 1) Reduce the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF), 2) Improve health related quality of life, 3) Reduce the need for hospitalization, and 4) Change ventricular refractoriness.

Plan: The study was a randomized double blind placebo controlled multi-center trial. Patients were randomized to either 25 mg per day of spironolactone or placebo and followed for 2 years each. The primary endpoint is time to the first episode of VT/VF. Secondary endpoints will include changes in health related quality of life, frequency of hospitalization, and in a subset of patients the effect of spironolactone on the ventricular effective refractory period measured through the ICD 3 months after starting the study medication. All data analyses will be conducted on intent to treat basis.

Methods: Patients were recruited at the Portland VA ICD clinics, the Seattle VA ICD clinics, Oregon Health and Sciences University ICD clinics and the Little Rock, Arkansas VA ICD clinics. Randomization and drug preparation were done by the Portland VA Medical Center research pharmacy. For safety purposes serum potassium will be measured at 1, 2, 3, 6, 12, 18, and 24 months. Patients will undergo ICD interrogation to document the occurrence of ICD therapy for VT or VF and will be screened for potential drug side effects every 3 months during the study. Health related quality of life will be measured at baseline, 3, 6, 12, 18, and 24 months using Short Form Health Survey adapted for veterans (SF36V) Veterans Health Study Version, the Patients Concerns Assessment, and the Kansas City Cardiomyopathy Questionnaire. Hospitalizations will be tracked throughout the study. In the subset of patient enrolled at the Portland VA the ventricular effective refractory period will be measured via single extra stimuli pacing through the ICD at 3 months after randomization.

Being tested
spironolactone, placebo
Keywords
Anti-Arrhythmia Agents, Ventricular Fibrillation, Ventricular Tachycardia, Defibrillators, Implantable
Medical subject headings
Ventricular Fibrillation, Tachycardia, Ventricular

What participants receive

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

  • spironolactoneDrug

    Also called Aldactone

    aldosterone blocker

  • placeboDrug

    identical in appearance to spironolactone study drug

Study groups in NCT04495712
Study groupRoleWhat they receive
SpironolactoneActive comparatorPatients randomized to active therapy with spironolactone
Receives: Drug: spironolactone
placeboPlacebo comparatorpatients randomized to placebo
Receives: Drug: placebo

What is being measured

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

  1. Time to First Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy

    Time to first documented ICD therapy for ventricular tachycardia or ventricular fibrillation after randomization

    Measured: through study completion, an average of 35 months

Secondary outcomes (5)

  1. All Cause Hospitalization

    Number of patients hospitalized for any reason during study follow-up.

    Measured: through study completion, an average of 35 months

  2. Ventricular Refractoriness

    The right ventricular effective refractory period (ERP) will be measured at 3 month in patients enrolled at the Portland VA Medical Center by single extra stimuli via their implanted defibrillator. The ERP is defined as the shortest paced beat coupling interval that fails to produce ventricular capture after a baseline stable pacing train.

    Measured: measured 3 months after randomization

  3. Short Form Health Survey Adapted for Veterans (SF36V)

    Short Form Health Survey adapted for veterans (SF36V) is a 36 item questionnaire that measures general physical and mental health [17]. The SF36V is a reliable and valid questionnaire, containing eight constructs of health status: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health perceptions (GH), energy/vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). These eight dimensions can be summarized numerically into two scores, the physical component summary (PCS) and the mental component summary (MCS). Range 0-100 higher score is better Health Related Quality of Life (HRQOL). We are reporting the Mental Component Summary score at 12 months here.

    Measured: 12 months after enrollment

  4. Patient Concerns Assessment (PCA)

    Patient Concerns Assessment (PCA) is a symptom checklist that measures physical symptoms and fears that are common after ICD implantation. The PCA is a disease-specific instrument for ICD QOL, symptoms, and distress, with a reliability of ( = 0.88). Range 0-44, a higher score reflects more concerns and fears.

    Measured: 12 months

  5. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item reliable and valid questionnaire, which evaluates HRQOL in heart failure. It quantifies, in a disease-specific fashion, physical limitations, symptoms, quality of life, social interference and self-efficacy. KCCQ provides the calculation of 2 main scores, the overall score and the clinical summary score, which includes functional status, social limitation and quality of life domains scores. Range 0-100, higher scores represent higher HRQOL.

    Measured: through study completion, an average of 35 months

Timeline

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

  1. First posted3 Aug 2020
  2. Study start28 Jul 2004
  3. Primary completion28 May 2008
  4. Study completion28 May 2008

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This was a prospective, double-blind, randomized trial that assigned patients to receive either spironolactone 25 mg/day or a placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04495712
Sponsor's protocol ID
ICDAD-1
Other IDs
VA 02-2704
Acronym
SPIRIT
Status last verified
Oct 2020
First submitted
28 Jul 2020
Last updated
9 Oct 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Patients did not give permission for data sharing

Publications

  • Zarraga IG, Dougherty CM, MacMurdy KS, Raitt MH. The effect of spironolactone on ventricular tachyarrhythmias in patients with implantable cardioverter-defibrillators. Circ Arrhythm Electrophysiol. 2012 Aug 1;5(4):739-47. doi: 10.1161/CIRCEP.112.970566. Epub 2012 Jul 7.

    PubMed 22773022

  • Liberato ACS, Raitt MH, Zarraga IGE, MacMurdy KS, Dougherty CM. Health-Related Quality of Life in the Spironolactone to Reduce ICD Therapy (SPIRIT) Trial. Clin Nurs Res. 2022 May;31(4):588-597. doi: 10.1177/10547738211036817. Epub 2021 Aug 6.

    PubMed 34362264

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing spironolactone in people with Ventricular Arrhythmias, run by VA Office of Research and Development at 1 site in United States.

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 4 inclusion and 8 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: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy (time frame: through study completion, an average of 35 months). 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 NCT04495712, which also lists 2 linked publications.

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 9 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in