A Phase 3 interventional study of Sacubitril / Valsartan Oral Tablet [Entresto] in Pulmonary Hypertension, sponsored by Germans Trias i Pujol Hospital. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Germans Trias i Pujol Hospital · Phase 3, Interventional, and Treatment
This study will assess the impact of sacubitril/valsartan on elevated pulmonary artery (PA) pressures in patients with heart failure (HF) with preserved ejection fraction (HFpEF), measured using a previously implanted hemodynamic monitoring device (CardioMEMS).
Fluid overload leading to increased PA pressure is one of the primary causes of HF related hospitalizations in HFpEF. Signs and symptoms of fluid overload are not sensitive enough to reflect early pathophysiologic changes that increase the risk of decompensation. Elevations in PA pressure may increase several days or weeks before signs and symptoms manifest.
The CardioMEMS device is a small wireless sensor that is permanently implanted in the PA via a catheter inserted through the femoral vein. The sensor measures PA pressure and is paired with a portable electronic transmitter. The system allows patients to wirelessly transmit pressure readings to a secure online database from which treating physicians can access the data and adjust medication in response to PA pressure changes.
The CHAMPION trial was a single blind randomized clinical trial that showed a significant and large reduction in hospitalizations in patients with NYHA class III HF who were managed with a the CardioMEMS device.
More recently, real life clinical practice has confirmed the value of PA pressure-guided therapy for HF. PA pressures were reduced, lower rates of HF hospitalizations and all-cause hospitalization, and low rates of adverse events across a broad range of patients with symptomatic HF and prior HF hospitalizations were reported.
The angiotensin receptor-neprilysin inhibitor (ARNI) led to a reduced risk of hospitalization for HF or death from cardiovascular causes among patients with HF and reduced ejection fraction in the PARADIGM-HF trial. However it did not result in a significantly lower rate of total hospitalizations for HF and death from cardiovascular causes among patients with HF and an ejection fraction of 45% or higher in the PARAGON-HF trial, despite there was suggestion of heterogeneity with possible benefit with sacubitril-valsartan in patients with lower ejection fraction and in women.
ARNI reduced pulmonary pressures and vascular remodeling in an animal model of pulmonary hypertension (PH) and may be appropriate for treatment of PH and right ventricle dysfunction. Data are lacking on the hemodynamic effects of ARNI on pulmonary hypertension in patients with HFpEF.
This study will assess the impact of sacubitril/valsartan on PA pressures measured using an implanted PA monitoring device. The device will be used according to approved indications.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 14 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Germans Trias i Pujol Hospital is the lead sponsor of 87 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All the subjects will receive sacubitril/valsartan from weeks 6 to 12. From weeks 1-6 and 12-18 patients will be treated with standard therapy for HFpEF according to PA pressures (diuretics and systemic vasodilators if concomitant hypertension). All the subjects will also receive longitudinal pulmonary artery pressure monitoring using a previously placed implantable hemodynamic monitor (CardioMEMS device). Device: Patients eligible for this study are those with an already implanted CardioMEMS device. Drug: Sacubitril/Valsartan Target dose:97/103mg bid
Drug: Sacubitril / Valsartan Oral Tablet [Entresto]
Treatment of Pulmonary Hypertension With Angiotensin II Receptor Blocker and Neprilysin Inhibitor
Change in mPAP With Sacubitril/Valsartan compared to Standard therapy
Change in Mean Pulmonary Artery Pressure With Sacubitril/Valsartan compared to Standard therapy.
Time frame: Time Frame: 0-18 weeks
Mean Change in mPAP
Mean Change in mPAP on Sacubitril/Valsartan (7 days after first dose of sacubitril/valsartan).
Time frame: 7 days
Change in Distance Walked
Change in Distance Walked During a Standard 6 Minute Walk
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Change in NT-proBNP concentration
Change in NT-proBNP (pg/ml)
Time frame: 6-12-18 weeks
Change in CA-125 concentration
Change in CA-125 (u/ml)
Time frame: 6-12-18 weeks
Change in Soluble ST2 concentration
Change in Soluble ST2 (ng/ml)
Time frame: 6-12-18 weeks
Change in the European Quality of Life-5 Dimensions scale
Minimum value of 5, maximum value of 15. Higher scores mean a worse quality of life.
Time frame: Baseline, 18 weeks
Change in the short version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Minimum value of 0, maximum value of 100. Higher scores mean a better quality of life.
Time frame: Baseline, 18 weeks
Change in Daily Diuretic Dose
Mean Change in Total Daily Diuretic Dose
Time frame: Baseline-6-12-18 weeks
Change in E/e'
Mean Change in diastolic dysfunction echocardiography parameter E/e'
Time frame: 6 weeks, 12 weeks, 18 weeks
Change in septal e' velocity
Mean Change in diastolic dysfunction echocardiography parameter Septal e' velocity (m/s)
Time frame: 6 weeks, 12 weeks, 18 weeks
Change in lateral e' velocity
Mean Change in diastolic dysfunction echocardiography parameter lateral e' velocity (m/s)
Time frame: 6 weeks, 12 weeks, 18 weeks
Change in diastolic dysfunction echocardiography parameter tricuspid regurgitation velocity
Mean Change in diastolic dysfunction echocardiography parameter tricuspid regurgitation velocity (m/s)
Time frame: 6 weeks, 12 weeks, 18 weeks
Change in diastolic dysfunction echocardiography parameter left atrium volumen index
Mean Change in diastolic dysfunction echocardiography parameter left atrium volumen index (ml/m2)
Time frame: 6 weeks, 12 weeks, 18 weeks
Change in the number of B-lines in lung ultrasound LUS
Mean Change in the number of B-lines in lung ultrasound
Time frame: 6 weeks, 12 weeks, 18 weeks
Decline in renal function
Decline in renal function (decrease in the estimated glomerular filtration rate of ≥50%, development of end-stage renal disease, or death due to renal failure)
Time frame: Baseline-18 weeks
Prespecified adverse events of interest
Hypotension with systolic blood pressure \<100 mmHg, hyperkalemia (\>5.5mmol/L), and angioedema are prespecified adverse events of interest
Time frame: Baseline-18 weeks
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Germans Trias i Pujol Hospital