Article Impact Level: HIGH Data Quality: STRONG Summary of European Heart Journal, ehac389. https://doi.org/10.1093/eurheartj/ehac389 Dr. Theresa Marie Dachs et al
Points
- The trial’s purpose was to evaluate the clinical and hemodynamic effect, tolerability, and safety of riociguat therapy among patients of heart failure with pulmonary hypertension and preserved ejection fraction.
- The results of the hemodynamic trial indicated positive effects of riociguat therapy and improved cardiac output.
- The study was limited as most patients were from one hospital, and not a diversified population was there. The results can’t be generalized.
Summary
The DYNAMIC trial study was a randomized, multicenter, placebo-controlled, double-blind IIB trial between 5 hospitals across Germany and Austria. A sample of 58 patients for riociguat and 56 for placebo therapy was selected. The study comprised 2 phases: an 8-week phase of up-titration and an 18-week phase of fixed-dose treatment. The thermodilution method was used to determine cardiac output by noticing the characterization of the right heart at the 26th week. Inclusion criteria were set as age between 18-80 years, unchanged medical treatment for more than 30 days before the enrollment, mean left ventricular ejection fraction of 60%, mean pulmonary artery pressure less than 25mmH, and mean pulmonary arterial wedge pressure less than 15mmHg. Patients having serious heart problems like heart failure with reduced ejection fraction, chronic thromboembolic pulmonary hypertension, amyloidosis, significant pulmonary disease, pulmonary arterial hypertension, or chronic coronary artery disease were excluded.
The trial result indicated that riociguat helps improve cardiac output among patients of PH and HfpEF. Some adverse effects were also noted in the riociguat arm compared to the placebo. No significant differences were noted in functional or NT-proBNP outcomes. The results of previous studies show no clinical benefits of a guanyl-cyclase stimulator for patients with heart failure with preserved ejection fraction. In this study, heart failure with preserved ejection fraction was comorbid with pulmonary hypertension, and the findings show positive effects with respect to safety. There is a need for further investigations to verify that the betterment of cardiac output also helps in the improvement of clinical outcomes.
Link to the article: https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehac389/6652608
References Dachs, T.-M., Duca, F., Rettl, R., Binder-Rodriguez, C., Dalos, D., Ligios, L. C., Kammerlander, A., Grünig, E., Pretsch, I., Steringer-Mascherbauer, R., Ablasser, K., Wargenau, M., Mascherbauer, J., Lang, I. M., Hengstenberg, C., Badr-Eslam, R., Kastner, J., & Bonderman, D. (2022). Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: The haemoDYNAMIC trial. European Heart Journal, ehac389. https://doi.org/10.1093/eurheartj/ehac389
