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Search / Trial NCT03968549

Probiotics and Inflammatory Status in Patients With Heart Failure

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · May 29, 2019

Trial Information

Current as of June 06, 2025

Unknown status

Keywords

Probiotics Inflammation Heart Failure Intestinal Microbiota

ClinConnect Summary

The present study will be a clinical trial compounded by two parallel arms, randomized, double-blind (researcher-patient), placebo-controlled, with patients with heart failure (HF), functional class according the New York Heart Association (NYHA) III and IV. It will be included 58 patients, 29 will receive probiotics and 29 will receive placebo. These patients will be accompanied during 6 months and should take one capsule every day during the study. In the beginning of the study and at the end, venous blood sample will be collected of each patient for laboratory measurement of TNF alpha, i...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with heart failure NYHA functional class III and IV;
  • Medications optimized for at least 2 months;
  • No hospitalizations for HF decompensated or acute myocardial infarction in the last 30 days;
  • Have signed the Free and Informed Consent Form
  • Exclusion Criteria:
  • Do not accept to participate in the study or do not signed the Free and Informed Consent Form
  • Have used antibiotics and/or corticosteroids in the last 30 days;
  • Clinical conditions that can affect the inflammatory profile such as inflammatory bowel disease, arthrosis, among others;
  • Be pregnant;
  • Have been submitted to a cardiac surgery in the last 6 months or other surgery in the last 3 months

About University Of Sao Paulo General Hospital

The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.

Locations

São Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Fernando Bacal, MD PhD

Principal Investigator

Heart Institute (InCor), University of Sao Paulo, Medical School

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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