Left Ventricular Dysfunction Clinical Trial
Official title:
Reverse Remodeling is Associated With Hemodynamic Improvement and Stabilization in Outpatients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan: an Echocardiographic Study
This prospective study evaluates the mechanisms of benefit of sacubitril/valsartan in a population of outpatients with heart failure with reduced ejection fraction, to investigate the relationship between the effects on left ventricular ejection fraction and volumes and noninvasively hemodynamic echo-derived parameters, as cardiac output and left ventricular filling pressure.
Therapeutic interventions were made according to a titration protocol in stable optimal
medical therapy. Therapy with sacubitril/valsartan was introduced after a 48-hour wash-out of
an ACE inhibitor or after a 24-hour wash-out of an angiotensin receptor antagonist. Doses of
sacubitril/valsartan were optimized to individual tolerability.
Echocardiography was performed at baseline and after 12 months. LV end-diastolic and
end-systolic volumes were calculated according to the biplane Simpson's method according to
the recommendations of the American Society of Echocardiography and European Association of
Cardiovascular Imaging. Doppler examinations included assessment of early diastolic filling
velocity and early diastolic mitral annular velocity, an averaged E/e' ≥ 13 was considered a
surrogate marker of increased filling pressure.
The LV stroke volume was calculated as the product of the LV outflow tract area and the
time-velocity integral of the aortic flow velocity or was evaluated as the difference between
LVEDV and LVESV. The LVSV index was estimated as LVSV divided by body surface area. Cardiac
output (CO) was measured as stroke volume times heart rate, and the cardiac index was
estimated by dividing CO by body surface area.
Patients who presented reverse remodeling were considered those exhibiting a ≥ 10% increase
in ejection fraction and ≥15% reduction in end-systolic volume compared to baseline.
The accuracy of the sources data was verified by using in-hospital medical records,
computerized or paper, by checking data from ultrasound images, laboratory reports or
ambulatory cardiological tests.
Detailed information on patients' medical history, including medications and loop diuretic
doses, was recorded for each patient. Patients' functional status was determined according to
the classification of the New York Heart Association. Creatinine, B-type natriuretic peptide
and amino-terminal pro-type B-natriuretic peptide levels were measured using standard
laboratory methods. The estimated glomerular filtration rate was calculated by the
Modification of Diet in Renal Disease formula.
Patients were removed from therapy with sacubitril/valsartan or assessment for non-adherence
to treatment or persistent drug-related adverse event with his/her willingness to discontinue
treatment.
Continuous measures were expressed as the mean value ± SD or median and interquartile range
(IRQ) for normally and non-normally distributed variables, respectively. Continuous data were
compared using paired and independent samples Student t-test or ANOVA when appropriate.
Categorical variables were presented as percentages and were compared using Chi-square or
McNemar test. Mann-Whitney, Kruskal-Wallis and Wilcoxon tests were used to analyze
non-normally distributed variables. All differences were considered significant at the p =
0.05 level. Data were analyzed with SPSS version 23.0 (IBM Corp., Armonk, NY).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05529654 -
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
|
N/A | |
Recruiting |
NCT04671966 -
Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction
|
Phase 4 | |
Not yet recruiting |
NCT05188222 -
Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery
|
Phase 4 | |
Recruiting |
NCT04950218 -
The Psoriasis Echo Study
|
||
Completed |
NCT01128790 -
Pilot Study of Remote Ischemic Preconditioning in Heart Failure
|
N/A | |
Completed |
NCT01076920 -
Mesenchymal Stem Cells and Myocardial Ischemia
|
Phase 1/Phase 2 | |
Completed |
NCT04942353 -
Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients
|
N/A | |
Recruiting |
NCT05769036 -
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
|
N/A | |
Completed |
NCT03232736 -
InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
|
||
Recruiting |
NCT04694092 -
Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
|
N/A | |
Completed |
NCT02013037 -
The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
|
Phase 3 | |
Completed |
NCT01609738 -
Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum
|
Phase 1/Phase 2 | |
Completed |
NCT00551681 -
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
|
N/A | |
Not yet recruiting |
NCT04103008 -
Left Ventricular Function After Primary Percutaneous Coronary Intervention: Role of Speckle Echocardiography
|
||
Completed |
NCT06197256 -
Cardiac Dysfunction in Critically Ill Covid-19 Patients
|
||
Recruiting |
NCT05860504 -
Acute Cardiac Dysfunction in Critical Illnes
|
||
Completed |
NCT03787810 -
Left Ventricular Dysfunction in Critically Ill Patients
|
||
Completed |
NCT01093001 -
Tricuspid Regurgitation Study
|
Phase 4 | |
Active, not recruiting |
NCT00461734 -
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
|
N/A | |
Recruiting |
NCT04752293 -
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
|