SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)
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ClinicalTrials.gov Identifier: NCT00604006 |
Recruitment Status :
Completed
First Posted : January 29, 2008
Last Update Posted : June 4, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Drug: Spironolactone Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study) |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A |
Drug: Spironolactone
25 mg tablets (placed in capsules for blinding) once daily. |
Placebo Comparator: Group B |
Drug: Placebo
Placebo (lactose in capsules for blinding) once daily |
- Effectiveness of Spironolactone in preventing heart failure [ Time Frame: 1 year and 3 year ]
- Cost effectiveness of Spironolactone prevention [ Time Frame: 3 years ]
- 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 ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Was recruited to SCREEN-HF
- Has provided informed consent
Exclusion Criteria:
- Uncorrected hyperkalaemia
- eGFR < 30 ml/min

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604006
Australia, Victoria | |
Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Henry Krum, MBBS FRACP PhD | Monash University / Alfred Hospital |
Responsible Party: | Prof Henry Krum, Monash University |
ClinicalTrials.gov Identifier: | NCT00604006 |
Other Study ID Numbers: |
CP-02/07 |
First Posted: | January 29, 2008 Key Record Dates |
Last Update Posted: | June 4, 2015 |
Last Verified: | June 2015 |
Prevention of heart failure in individuals at high risk |
Heart Failure Heart Diseases Cardiovascular Diseases Spironolactone Mineralocorticoid Receptor Antagonists Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents |