- My name is Joan Carles Trullas.
And I am a specialist in internal medicine
and I work in the Hospital of Olot County
and which is in Girona North of Spain.
I am also lecturer in the school of medicine
at the University of Vic in Barcelona.
And I also belong to the Heart Failure Working Group
of the Spanish Society of Internal Medicine.
And I'm going to talk you about the results,
preliminary results, of the CLOROTIC trial.
Which is a trial that investigates
the different diuretic strategies.
There are very few prospective trials
evaluating safety and efficacy of diuretic strategies.
And this is the reason why most guidelines
and recommendations are based on expert opinion
because there are few randomised chemical trials.
But in this context
when patients are exposed to loop diuretics chronically,
some patients may present diuretic resistance.
And some subset of these patients
can persist with fluid overload.
Despite you increase the doses of loop diuretics.
One possible approach to overcome
this theoretical resistance is the addition
of a second class of diuretics.
And in this case a TSI type diuretic.
But this strategy has not been tested
in large scale clinical trials.
For this trial,
this is a randomised double blind placebo control trial
perform at 26 sites in Spain.
And we recruited 230 patients
with a history of chronic heart failure
admitted for an acute decompensation.
Despite receiving treatment at home with oral furosemide
at the minimum dose of 80 milligrammes per day.
And these patients were randomised within the first 24 hours
of hospital admission to receive oral treatment
with hydrochlorothiazide or placebo.
All patients were treated with pre-specified algorithm
for furosemide treatment that was provided
to all investigators to standardise its use
between different sites.
And in addition
to this pre-specified furosemide intravenous treatment
patients were assigned to two arms.
One arm was hydrochlorothiazide, oral hydrochlorothiazide,
and the other side was placebo.
And we wanted to test if combined diuretic therapy
was superior to placebo or furosemide alone with placebo
to improve the diuretic response in these patients.
According to the primary endpoint,
we found that the patients assigned to hydrochlorothiazide
were more likely to lose weight
than those assigned to placebo 72 hours after randomization.
And these were, these results were statistically significant
and there was also a trend towards better scores
for the this the assessment for these patients.
But in this case,
the results were not statistically significant.
We also assessed the same endpoint
a secondary endpoint at day five after randomization.
And we obtain the same result with more weight loss
for the patients assigned to the treatment.
Another important thing is that as a secondary endpoint
we included the metrics of diuretic response
and we observed that patients assigned
to the treatment group, hydrochlorothiazide,
also improved all the metrics of diuretic response.
And furthermore, I think it's important
that it was a safe strategy.
Because in the safe TM points, we didn't see safety concerns
using combined diuretic therapy
in comparison with furosemide alone.
So this is, I think it's important to demonstrate efficacy
but also safety of this strategy.
In patients with chronic heart failure
who are decompensated despite treated with oral furosemide,
we didn't know with, we didn't have the evidence.
Which is the second first line agent, diuretic agent.
Some expert recommend TSI diuretics
but we didn't have the evidence.
But now we think that at the light of this result
we have the evidence to recommend as first last line
a second diuretic agent hydrochlorothiazide.
And maybe we can change clinical practise in this situation.
I hope so.
Being aware of more clinical trials with diuretics
which are really scarce in the literature.
But we hope to continue this line of research
and doing more research in diuretic therapy in the future.