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OpenTrials
Completed

NCT Number: NCT01598740

Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orange Country Research Center

Tustin, California, 92780, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Heart failure with New York Heart Association (NYHA) Classification II or III
  • Chronic kidney disease
  • Cardiac ejection fraction <40%
  • On heart failure therapy including an ACEI or ARB, and a BB
  • Willing to understand and comply with study procedures and provide written informed consent.

Exclusion criteria

  • Hospitalization within 4 weeks of baseline visit
  • History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
  • Current or anticipated dialysis during study
  • In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
  • Drug or alcohol abuse

Treatment and study plan

CLP

Drug

Oral administration

Spironolactone

Drug

oral administration

Primary outcomes

  1. Change in Fecal Sodium Content

    Time frame: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)

    Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)

Secondary outcomes

  1. Change in Fecal Weight

    Time frame: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)

    Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)

Sponsors and collaborators

Lead sponsor

Sorbent Therapeutics

Industry

Registry information

Official study title

A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 15, 2012
Registry last updated
Jul 19, 2013

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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