we did a very large clinical trial
called the saudi major trial which tested
whether or not we should continue to
recommend reducing dietary sodium for patients with
heart failure we'd said about the study
after a really good clinical question asking
the question doesn't really matter if we
give all these dietary reckon
nations for patients partier and we did
a randomized clinical trial very difficult to
do as people eat food from a
variety different a ways that we said
about doing this and we and roll
over eight hundred patients in twenty six
sites across six countries and the clinical
trial lasted about a year for each
patient
we randomize patients to either the intervention
arm which was targeting a dietary sodium
intake of less and fifteen hundred milligrams
of sodium per day or usual care
which the recommendations and eighty one of
us may have given in clinical practice
to these patients with heart failure included
patients who had heart your back clinical
diagnosis and we've kept a very pregnant
talk without requiring any additional a specific
inclusion or exclusion criteria that would make
it very narrow at the end of
the trial but we did have some
other inclusion an exclusion criteria
but nothing of a major i sorts
of an excellent most of our patients
we've all these patients ford i every
three months with pretty food records and
of the we we designed the trial
really really wanted to move the needle
do an ama never trial so made
the primary endpoint the composite of all
cause mortality
cardenas for hospitalizations or party bastard your
visits as that cop as it was
assessed the twelve months of the primary
endpoint overall was neutral for the reductions
in added the clinical events
the hazard ratio did indicate is your
point eight nine so hundred you as
racial did say in in in effect
there were fewer events nations animals or
dm arm this was not statistically significant
or secondary and points which were quite
important i that of quality of life
and why jay class and six when
a walked test
i'm patients and had a greater equality
life on a lower sodium arm by
the kishi cq i got three and
a half points across the overall summary
score the clinical summary score as well
as looking at the physical limitation score
was is very much in line with
other are trials with pharmacologic agents testing
strategies to improve asians i'll come the
overall and why ha class was awesome
interesting how come we found the patients
on the lower sodium arm were more
likely to improve by least one and
wage a classic there on the low
sodium arm compared to usual care
and then overall the six when a
walk test which was under powered unfortunately
due to the issues were uncovered
just getting this trial completed was didn't
show any significant difference a little there
was a numerical improvements are walked as
over the year by patients in the
lower saudi warm we just didn't have
enough power to demonstrate a difference over
there are so statistically neutral on that
come
so one of the common questions that
we've had about the study are beyond
why did we saw to do this
which was it just a good clinical
question to ask was we really wanted
to understand whether or not weaken our
first or get people's dietary sodium as
low as we think we should lessen
fifteen hon rounds per day or compared
to the usual care what
are twenty three to twenty four hundred
milligrams per day
and he answered that question we found
in both the pilot study to the
to the main trial but also the
main trial was we could get patients
pretty close their lesson fifteen hundred milligrams
per they are on average the reduction
and in a dietary sodium arm was
about four hundred and fifty milligrams less
than the usual care arm and his
usual care
from really didn't change their dietary sodium
intake of the twelve months with the
intervention arm good we got about an
extra four hundred and fifty milligrams per
day reduction in ah that arm it's
got a twenty percent reduction which i
would challenge any of us to reduce
our dietary sodium at home to that
amount it's actually
he not easy and our patients put
in your best effort as our volunteers
in this trial and they are able
to accomplish it
another question were often asked his you
know why do we choose to do
this in the different areas of the
world we did this and six countries
and would have that nice parts lived
in scientific collaboration but also thinking about
the pragmatic featured this trial was the
six countries have very different eating habits
that of cultures and how they eat
foods as well as
languages so we had to think carefully
about how to we deployed this trial
in as a clinical practice after the
trial is done so we were lucky
to have collaborators across the globe am
i'm really we had them refine the
menu based system which we had our
the as the intervention to be very
local to the food as we couldn't
apply will might apply and
a western canada to add middle parts
of canada or columbia actually without even
thinking it through as what foods are
available so a lot of the learning
from this trial
meant the we actually do have a
way to translate this into clinical practice
and because in the ever put in
by i are dietitians and clinician colleagues
who helped refine this trial and in
into it i can have a meaningful
many based system for as an intervention
from later
well there's a couple different ways to
think about it first of all on
a coalition level of you know it
does this trial affect how we should
practice and i think of this is
the largest and longest trial of it's
type testing the strategy of dietary sodium
reduction am i think
the should ultra how we think about
the intervention so rather than just in
every clinic isn't saying you reduce your
dietary sodium as our standard mantra think
we should look carefully with patients goals
are
i think we can safely say that
we improved quality of life and in
which a class we had a numerical
been on a statistical reduction in in
the clinical events
so i do think the clinicians to
be cautious about what the goals are
and what we're trying to achieve and
if a patient agrees of improving quality
of life is one of the things
that they want to go after it
certainly feasible to get the battery so
reduction but i have but else that
we need to back off on a
lot of the oh what is i
often call the finger
wagging
which is about people not falling a
strict dietary sodium reduction i think we
need to be little bit more cautious
and and think through as to what
the goals are impatient carrying this regard
so question should take a step back
perhaps of a lucky whether or not
there are feels as strongly about this
practice and now that they've seen the
clinical trial results
from a patient's perspective i do think
that is this is still important as
an overall dietary health strategy and that's
the part of everything else we do
and as we should do it if
you do or don't have heart disease
of we should still consider dietary interventions
that are that they can have an
impact on life and and quality of
life especially
from the results are city major were
doing a number of secondary analyses to
really understand our a completeness of the
data we did collect and over eight
hundred patients with serial food records and
from many different tack a cultures and
areas of the planet
i'm our next steps are really looking
closely at the dietary data to understand
if there's dietary patterns the me be
advantageous to certain individuals vs others were
looking at the follow up ah the
follow up study which is a two
in a five year outcomes which we
think be very important to think by
the longevity of batteries
sodium reduction of maybe takes longer to
have an hour outcome effect
we're also looking out all in non
cardiovascular outcomes so do patients with a
sodium were lower sodium diet have fewer
non cardiovascular events are we really didn't
make as a primary endpoint the maybe
they are quite important occupations overall and
finally i think this is the first
one i think we need to do
more clinical trials of this
nature
where we are testing and strategy of
an intervention that we think is just
the right thing to do in clinical
practice we don't have evidence do so
so we really need to do more
trials asking needs is harder question is
is is is was a hard trial
to do and it's important for patients
and clinicians alike so i think it's
important to do continued research and clinical
trials
of this nature
i think the results of sodium hf
a really do stimulate our our thoughts
around what do we do with our
general recommendations for clinical care around diet
physicians as physicians were not very well
educated often i am dietary interventions and
that doesn't matter if it's leopards or
salt or other interventions but i think
we do need to am
become more educated in that for our
patients sake but on the flipside we
also need to look at what is
the evidence for each of these things
and we recommend routine daily practice i
do think as a clinicians we also
need to think carefully about how to
which he the best overall care for
patients that often includes all the non
pharmacologic therapies we were
command such his new nutritional and a
interventions are as flu destruction matter anymore
how often should i see my patient
in terms of in follow up all
these things and we often wonder about
and me we need to get better
at asking these questions and then testing
them with their within the randomized trial
for man rather than letting them sit
out there is an open question