Sildenafil in heart failure with reactive pulmonary hypertension (Sildenafil HF) clinical trial (rationale and design)

Abstract

In this article, we present the rationale and design of the Sildenafil HF trial (ClinicalTrials.gov identifier: NCT02304705). We will randomize patients with heart failure and reactive pulmonary hypertension (pulmonary capillary wedge pressure > 15 mmHg, pulmonary vascular resistance > 3 Wood units) into two groups: the treatment group receiving sildenafil 20 mg 3 times a day and a matching placebo group. The duration of intervention will be 3 months. The primary outcome is 6-minute walk distance. Key features of this trial include (1) that reactive pulmonary hypertension is an inclusion criterion, (2) that patients will be enrolled regardless of left ventricular ejection fraction, and (3) that clinical stability in the 3 months preceding enrollment is not required.

Keywords: heart failure; pulmonary hypertension; sildenafil.

Figures

Figure 1

Trial design. NT-proBNP: N-terminal of the prohormone brain natriuretic peptide; mPAP: mean pulmonary arterial pressure; WU: Wood units; TID: three times/day; PO: orally (per os); QOL: quality of life.