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

NCT ID: NCT00604006

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Group Type EXPERIMENTAL

Spironolactone

Intervention Type DRUG

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

Group B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (lactose in capsules for blinding) once daily

Interventions

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Spironolactone

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

Intervention Type DRUG

Placebo

Placebo (lactose in capsules for blinding) once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Was recruited to SCREEN-HF
2. Has provided informed consent

Exclusion Criteria

1. Uncorrected hyperkalaemia
2. eGFR \< 30 ml/min
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart Foundation, Australia

OTHER

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role lead

Responsible Party

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Prof Henry Krum

Prof Henry Krum

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Krum, MBBS FRACP PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University / Alfred Hospital

Locations

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Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 33902478 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30057766 (View on PubMed)

Other Identifiers

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CP-02/07

Identifier Type: -

Identifier Source: org_study_id

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