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Heart FailurePhase 3NCT00604006

SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

A Phase 3 study testing Spironolactone in people with Heart Failure, run by Monash University at 1 site in Australia.

Completed

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

Official record
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Trial summary

Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP level are in the top quintile will be offered participation in this study. Participants will be randomised to receive either spironolactone or placebo for three years. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Failure
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
20 participants
Where
1 siteAustralia
Study dates
Sep 2008to Jan 2015
Phase
Phase 3
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Was recruited to SCREEN-HF
  • Has provided informed consent

Who cannot join

  • Uncorrected hyperkalaemia
  • eGFR < 30 ml/min

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP level are in the top quintile will be offered participation in this study. Participants will be randomised to receive either spironolactone or placebo for three years. Participants will then be monitored for indications of heart failure. It is anticipated that the medication will reduce the development of heart failure in this group.

Conditions
Heart Failure
Being tested
Spironolactone, Placebo
Keywords
Prevention of heart failure in individuals at high risk
Medical subject headings
Heart Failure

What participants receive

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

  • SpironolactoneDrug

    25 mg tablets (placed in capsules for blinding) once daily.

  • PlaceboDrug

    Placebo (lactose in capsules for blinding) once daily

Study groups in NCT00604006
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: Spironolactone
Group BPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Effectiveness of Spironolactone in preventing heart failure

    Measured: 1 year and 3 year

  2. Cost effectiveness of Spironolactone prevention

    Measured: 3 years

Secondary outcomes (4)

  1. Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure

    Measured: 1 year and 3 year

  2. Change in 6 minute walk test between the two groups

    Measured: 1 year and 3 years

  3. Change in quality of life between the two groups

    Measured: 1 year and 3 year

  4. Change in left ventricular remodelling parameters

    Measured: 1 year and 3 years

Timeline

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

  1. First posted29 Jan 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionAug 2014
  4. Study completionJan 2015

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00604006
Sponsor's protocol ID
CP-02/07
Status last verified
Jun 2015
First submitted
16 Jan 2008
Last updated
4 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Campbell DJ, Coller JM, Gong FF, McGrady M, Boffa U, Shiel L, Liew D, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL. Kidney age - chronological age difference (KCD) score provides an age-adapted measure of kidney function. BMC Nephrol. 2021 Apr 26;22(1):152. doi: 10.1186/s12882-021-02324-y.

    PubMed 33902478

  • Gong FF, Jelinek MV, Castro JM, Coller JM, McGrady M, Boffa U, Shiel L, Liew D, Wolfe R, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL, Campbell DJ. Risk factors for incident heart failure with preserved or reduced ejection fraction, and valvular heart failure, in a community-based cohort. Open Heart. 2018 Jul 23;5(2):e000782. doi: 10.1136/openhrt-2018-000782. eCollection 2018.

    PubMed 30057766

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Spironolactone in people with Heart Failure, run by Monash University at 1 site in Australia.

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 2 inclusion and 2 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 4 Jun 2015. 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 Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Effectiveness of Spironolactone in preventing heart failure (time frame: 1 year and 3 year). The study lists 2 primary outcomes in all. 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 NCT00604006, 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 4 Jun 2015.

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