---
title: SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
nct_id: NCT00604006
overall_status: COMPLETED
phase: PHASE3
sponsor: Monash University
study_type: INTERVENTIONAL
primary_condition: Heart Failure
countries: Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00604006.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00604006"
ct_last_update_post_date: 2015-06-04
last_seen_at: "2026-05-12T07:28:11.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

**NCT ID:** [NCT00604006](https://clinicaltrials.gov/study/NCT00604006)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Monash University
- **Collaborators:** National Heart Foundation, Australia
- **Conditions:** Heart Failure
- **Start Date:** 2008-09
- **Completion Date:** 2015-01
- **CT.gov Last Update:** 2015-06-04

## 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.

## Eligibility

- **Minimum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

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

Exclusion Criteria:

1. Uncorrected hyperkalaemia
2. eGFR \< 30 ml/min
```

## Arms

- **Group A** (EXPERIMENTAL)
- **Group B** (PLACEBO_COMPARATOR)

## Interventions

- **Spironolactone** (DRUG) — 25 mg tablets (placed in capsules for blinding) once daily.
- **Placebo** (DRUG) — Placebo (lactose in capsules for blinding) once daily

## Primary Outcomes

- **Effectiveness of Spironolactone in preventing heart failure** _(time frame: 1 year and 3 year)_
- **Cost effectiveness of Spironolactone prevention** _(time frame: 3 years)_

## Secondary Outcomes

- **Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure** _(time frame: 1 year and 3 year)_
- **Change in 6 minute walk test between the two groups** _(time frame: 1 year and 3 years)_
- **Change in quality of life between the two groups** _(time frame: 1 year and 3 year)_
- **Change in left ventricular remodelling parameters** _(time frame: 1 year and 3 years)_

## Locations (1)

- Alfred Hospital, Melbourne, Victoria, Australia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.alfred hospital|melbourne|victoria|australia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00604006.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00604006*  
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