Clinical Trial: CR Aim #2 - AT1 Receptor Blockade & ACE Inhibition Effect on Humoral Function

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Define in Humans With Compensated CHF and Renal Dysfunction, the Modulating Action of Chronic AT1 Receptor Blockade in Addition to ACE Inhibition on Cardiorenal and Humoral Function

Brief Summary:

To advance our understanding of the mechanisms of human cardiorenal syndrome with emphasis upon the interaction of diuretic therapy and the renal-angiotensin-aldosterone -system and cGMP pathway.

The belief is that the chronic AT1 receptor blockade in subjects with compensated CHF and renal dysfunction will improve renal function with increased sodium excretion, glomerular filtration rate and effective renal plasma flow and renal function reserve as compared to the response of placebo-treated subjects.


Detailed Summary: IRB # 09-003284, "Specific Aims 2: Define in humans with compensated CHF and renal dysfunction, the modulating action of chronic AT1 receptor blockade in addition to ACE inhibition on cardiorenal and humoral function", involving 12 weeks of study drug (Candesartan or placebo) starting at 4 mg daily and doubling every 2 weeks to 16 mg, if tolerated. Safety labs are performed one week after each dose increase (end of weeks 1, 3 and 5), and in week 10 of the study. Participants are monitoring their blood pressure weekly, and are aware to watch for symptoms of hypotension (lightheadedness, dizziness, blurred vision). Renal clearance testing and ECHO are performed at the start and end of the 12 weeks of study medication in the 5-Domitilla Clinical Research Unit.
Sponsor: Mayo Clinic

Current Primary Outcome:

  • Change in Glomerular Filtration Rate (mL/min/1.73 m2) [ Time Frame: baseline to 3 months ]
  • change in urinary Sodium excretion [ Time Frame: baseline to 4 months ]


Original Primary Outcome:

  • Change in Glomerular Filtration Rate (mL/min/1.73 m2) [ Time Frame: baseline to 6 months ]
  • change in urinary Sodium excretion [ Time Frame: baseline to 6 months ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: August 31, 2012
Date Started: February 2012
Date Completion: March 2017
Last Updated: March 24, 2017
Last Verified: March 2017