Gut flora profiling in heart failure patients

Not Applicable

• Conditions: Cardiovascular disease; Heart failure; Heart transplant; Cardiovascular - Other cardiovascular diseases; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12619001758190
• Lead Sponsor: Girish Dwivedi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-11
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Men and women between 40– 80 years of age presenting to Fiona Stanley Hospital with heart failure will be recruited for the study. Healthy family members of patients will be invited to take part in the study and will act as environmental controls and will be age matched where possible.

• The participant to present to FSH with heart failure
• Healthy participants will be relatives of heart failure patients and are defined as individuals
with no clinically relevant abnormalities identified by a detailed medical history, full
physical examination including blood pressure, heart rate, clinical lab tests from a
fasting blood sample
• Evidence of a personally signed and dated informed consent document indicating that
the participant has been informed of all pertinent aspects of the trial
• Willing and able to comply with study procedures, i.e. sample collection

Exclusion Criteria

Participants will be excluded from the study:
• If there are circumstances that interfere with the participant’s ability to give informed
consent (e.g. diminished understanding, or proficiency in English language and an
interpreter unavailable)
• Participants taking probiotics, antibiotics or antivirals which may disrupt gut
microbiota environment, current or recent <3 months.
• Major chronic disease e.g. cancer or dementia
• Healthy participants will be excluded if they have a history of major chronic disease
(including cardiovascular disease, psychiatric illness, cancer, diabetes), BMI <18 or
>35 kg/m2, current or recent (<12 months) smoking, current or recent (<6 months)
significant weight loss or gain (>6% body weight), alcohol intake >280g p/week for
men and >210g p/week for women.
• Inability to comply with study procedure

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stool microbiome as assessed by 16S rRNA gene sequencing analysis of stool sample[Stool sample provided at baseline (time zero) and 6 month follow-up.];Plasma short-chain fatty acids (SFCAs) as assessed by GCMS of plasma samples.[Plasma samples provided at baseline (time zero) and 6 month follow-up.]

Secondary Outcome Measures

Name	Time	Method
Medication usage as assessed by study-specific questionnaire.[Study specific questionnaire completed at baseline (time zero).];Diet in relation to changes in gut microbiome as assessed by study-specific questionnaire<br>[Study specific questionnaire completed at baseline (time zero).]