Heart Failure Clinical Trial
Official title:
A Randomized, Double-blind, Sponsor Un-blinded, Placebo-controlled, Phase 2a Crossover Study to Evaluate the Effect of the TRPV4 Channel Blocker, GSK2798745, on Pulmonary Gas Transfer and Respiration in Patients With Congestive Heart Failure
This study is a single centre, randomised, double-blind, sponsor-unblinded,
placebo-controlled, 2 by 2 crossover study in adults with heart failure. In blocking the
TRPV4 ion channel and reducing pulmonary interstitial fluid, GSK2798745 may improve pulmonary
function, respiration, and gas exchange as well as sleep-disordered breathing in patients
with heart failure. Therefore, the current study is designed to investigate the effect of
repeat administration of GSK2798745 on pulmonary gas exchange and pulmonary function.
A sufficient number of subjects with heart failure will be enrolled so that 12 subjects
complete the two study periods and critical assessments. Subjects will be randomised to
receive either GSK2798745 or placebo once daily for a period of 7 days in one treatment
period and alternate study medication in the second treatment period. Both the treatment
periods will be separated by a washout period of at least 14-days.
This study will consist of a Screening visit within 14 days of the start of Period I and two
treatment periods wherein eligible subjects will be randomised to one of the two treatment
sequences, a follow-up visit approximately 2 weeks after the completion of second study
period. The total duration of the study is approximately 8 weeks from screening to follow-up
visit.
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