NCT00604006

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

5.9 years

First QC Date

January 16, 2008

Last Update Submit

June 2, 2015

Conditions

Heart Failure

Keywords

Prevention of heart failure in individuals at high risk

Outcome Measures

Primary Outcomes (2)

  • Effectiveness of Spironolactone in preventing heart failure

    1 year and 3 year

  • Cost effectiveness of Spironolactone prevention

    3 years

Secondary Outcomes (4)

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

    1 year and 3 year

  • Change in 6 minute walk test between the two groups

    1 year and 3 years

  • Change in quality of life between the two groups

    1 year and 3 year

  • Change in left ventricular remodelling parameters

    1 year and 3 years

Study Arms (2)

Group A

EXPERIMENTAL
Drug: Spironolactone

Group B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SpironolactoneDRUG

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

Group A
PlaceboDRUG

Placebo (lactose in capsules for blinding) once daily

Group B

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Uncorrected hyperkalaemia
  • eGFR \< 30 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (2)

  • 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.

    PMID: 33902478DERIVED

  • 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.

    PMID: 30057766DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Henry Krum, MBBS FRACP PhD

    Monash University / Alfred Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Henry Krum

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2014

Study Completion

January 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

AU(1)