Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: the haemoDYNAMIC trial.
Eur Heart J
; 43(36): 3402-3413, 2022 09 21.
Article
en En
| MEDLINE
| ID: mdl-35909264
ABSTRACT
AIMS:
The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFpEF). To date, neither established heart failure therapies nor pulmonary vasodilators proved beneficial. This study investigated the efficacy of chronic treatment with the oral soluble guanylate cyclase stimulator riociguat in patients with PH-HFpEF. METHODS ANDRESULTS:
The phase IIb, randomized, double-blind, placebo-controlled, parallel-group, multicentre DYNAMIC trial assessed riociguat in PH-HFpEF. Patients were recruited at five hospitals across Austria and Germany. Key eligibility criteria were mean pulmonary artery pressure ≥25â mmHg, pulmonary arterial wedge pressure >15â mmHg, and left ventricular ejection fraction ≥50%. Patients were randomized to oral treatment with riociguat or placebo (11). Patients started at 0.5â mg three times daily (TID) and were up-titrated to 1.5â mg TID. The primary efficacy endpoint was change from baseline to week 26 in cardiac output (CO) at rest, measured by right heart catheterization. Primary efficacy analyses were performed on the full analysis set. Fifty-eight patients received riociguat and 56 patients placebo. After 26 weeks, CO increased by 0.37 ± 1.263â L/min in the riociguat group and decreased by -0.11 ± 0.921â L/min in the placebo group (least-squares mean difference 0.54â L/min, 95% confidence interval 0.112, 0.971; P = 0.0142). Five patients dropped out due to riociguat-related adverse events but no riociguat-related serious adverse event or death occurred.CONCLUSION:
The vasodilator riociguat improved haemodynamics in PH-HFpEF. Riociguat was safe in most patients but led to more dropouts as compared to placebo and did not change clinical symptoms within the study period.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Insuficiencia Cardíaca
/
Hipertensión Pulmonar
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
Eur Heart J
Año:
2022
Tipo del documento:
Article
País de afiliación:
Austria