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Completed

NCT Number: NCT00604006

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Uncorrected hyperkalaemia
  • eGFR < 30 ml/min

Treatment and study plan

Spironolactone

Drug

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

Placebo

Drug

Placebo (lactose in capsules for blinding) once daily

Primary outcomes

  1. Effectiveness of Spironolactone in preventing heart failure

    Time frame: 1 year and 3 year

  2. Cost effectiveness of Spironolactone prevention

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 1 year and 3 year

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

    Time frame: 1 year and 3 years

  3. Change in quality of life between the two groups

    Time frame: 1 year and 3 year

  4. Change in left ventricular remodelling parameters

    Time frame: 1 year and 3 years

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • National Heart Foundation, Australia

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Jan 29, 2008
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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