What is the clinical evidence from this study?

Study design: RCT. Population: Heart failure with preserved left ventricular ejection fraction (HFpEF) and pulmonary hypertension (PH). Intervention: Riociguat vs. Placebo. Primary outcome: Peak decrease in mPAP from baseline up to 6 h (p=.6).

July 3, 2014CHEST JournalOpen Access

Acute Hemodynamic Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure (DILATE-1)

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Key result

A single oral dose of riociguat 2 mg did not significantly change the peak decrease in mean pulmonary artery pressure compared to placebo in patients with HFpEF and PH (P=0.6).

Why the study?

Does a single oral dose of riociguat reduce mean pulmonary artery pressure in patients with pulmonary hypertension associated with HFpEF?

Key Points

This research aimed to evaluate the acute hemodynamic effects of riociguat in patients with pulmonary hypertension and diastolic heart failure.
Randomized trial with clinically stable patients on standard heart failure therapy; N=21 patients assigned to placebo or riociguat (0.5, 1, or 2 mg)
Primary outcome was peak decrease in mean pulmonary artery pressure (mPAP); measured for up to 6 hours after dosing
Secondary outcomes included hemodynamic measures, safety evaluations, and pharmacokinetics.
Riociguat 2 mg did not significantly change peak decrease in mPAP (P = .6)
Riociguat 2 mg significantly increased stroke volume by 9 mL (95% CI, 0.4-17; P = .04)
Systolic BP decreased by 12 mm Hg (95% CI, -22 to -1; P = .03), and right ventricular end-diastolic area reduced by 5.6 cm² (95% CI, -11 to -0.3; P = .04).

Study Design

Type

RCT

Randomization

randomized

Structured PICO

Does a single oral dose of riociguat reduce mean pulmonary artery pressure in patients with pulmonary hypertension associated with HFpEF?

Population

Clinically stable patients with HFpEF and PH receiving standard HF therapy, evaluated up to 6 hours after a single oral dose.

Intervention

Single oral doses of riociguat (0.5, 1, or 2 mg)

Comparator

Single oral dose of placebo

Outcome

Peak decrease in mPAP from baseline up to 6 hsurrogate

Main Result

p-value: p=.6

A single dose of riociguat did not significantly reduce mean pulmonary artery pressure in patients with PH and HFpEF, but did improve stroke volume and lower systolic blood pressure.

Discussion

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Implication

Riociguat shows limited acute hemodynamic impact in PH-HFpEF; leaves open whether sustained sGC stimulation improves outcomes in this population.

Cite This Study

Bonderman et al. (2014) conducted an RCT in Heart failure with preserved left ventricular ejection fraction (HFpEF) and pulmonary hypertension (PH). Riociguat vs. Placebo was evaluated on Peak decrease in mPAP from baseline up to 6 h (p=.6). A single oral dose of riociguat 2 mg did not significantly change the peak decrease in mean pulmonary artery pressure compared to placebo in patients with HFpEF and PH (P=0.6).

synapsesocial.com/papers/6a3fda3284e5814408cd6b85 https://doi.org/10.1378/chest.14-0106

Topics

Echocardiography

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Implication

Riociguat shows limited acute hemodynamic impact in PH-HFpEF; leaves open whether sustained sGC stimulation improves outcomes in this population.

Acute Hemodynamic Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure (DILATE-1)

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Topics

Acute Hemodynamic Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure (DILATE-1)

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider