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Soluble Guanylate Cyclase Stimulator

Riociguat for Pulmonary Hypertension Due to Heart Failure (LEPHT Trial)

Phase 2

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at visit 6 (16 weeks)

Awards & highlights

LEPHT Trial Summary

This trial will test if increasing doses of Riociguat are safe and improve symptoms in patients with PH caused by heart failure.

Who is the study for?

This trial is for men and women who have pulmonary hypertension due to weak heart pumping (left ventricular systolic dysfunction) despite being on the best treatment for heart failure. It's not open to those with other types of high blood pressure in the lungs besides group 2.1 as classified at Dana Point.Check my eligibility

What is being tested?

The study is testing Riociguat, a medication that might improve symptoms and overall health in patients with certain kinds of lung-related high blood pressure linked to heart issues. Participants will either receive Riociguat or a placebo without knowing which one they're getting.See study design

What are the potential side effects?

Riociguat can cause side effects like low blood pressure, headache, dizziness, upset stomach or indigestion, swelling of legs or arms, and potential risks during pregnancy.

LEPHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have high blood pressure in my lungs due to heart issues, despite treatment.

LEPHT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at visit 6 (16 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at visit 6 (16 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at visit 6 (16 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16

Secondary outcome measures

6-minute Walking Distance (6MWD) - Change From Baseline to Week 16

Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16

Borg CR 10 Scale - Change From Baseline to Week 16

+22 more

Side effects data

From 2016 Phase 4 trial • 75 Patients • NCT02191137

23%

Dizziness

21%

Nausea

20%

Dyspepsia

19%

Diarrhoea

17%

Headache

13%

Fatigue

12%

Vomiting

12%

Oedema peripheral

12%

Nasopharyngitis

12%

Hypotension

11%

Dyspnoea

11%

Constipation

11%

Gastrooesophageal reflux disease

11%

Chest pain

Back pain

Cough

Arthralgia

Insomnia

Palpitations

Abdominal pain

Peripheral swelling

Bronchitis

Influenza

Pneumonia

Sinusitis

Urinary tract infection

Hypokalaemia

Epistaxis

Hypoxia

Sepsis

Respiratory failure

Cardiac failure acute

Acute respiratory failure

Acute kidney injury

Iron deficiency anaemia

Cardiac failure congestive

Fluid overload

Gastritis

Respiratory distress

Aortic dissection

Retroperitoneal haemorrhage

Cholecystitis acute

Atrial fibrillation

Hyponatraemia

Cardiac resynchronisation therapy

Acute left ventricular failure

Rectal haemorrhage

Cholestasis

Thyroid cancer

Pleural effusion

Pulmonary embolism

Hepatic steatosis

Bronchitis viral

Anaemia

100%

80%

60%

40%

20%

Study treatment Arm

Riociguat (Adempas, BAY63-2521)

LEPHT Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Riociguat (Adempas, BAY63-2521) up to 2 mgExperimental Treatment1 Intervention

Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).

Group II: Riociguat (Adempas, BAY63-2521) up to 1 mgExperimental Treatment1 Intervention

Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).

Group III: Riociguat (Adempas, BAY63-2521) fixed 0.5 mgExperimental Treatment1 Intervention

Participants received riociguat 0.5 mg tid (fixed dose).

Group IV: PlaceboPlacebo Group1 Intervention

Participants received placebo tid.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Riociguat (Adempas, BAY63-2521)

2009

Completed Phase 4

~2990

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,776 Total Patients Enrolled

Bayer Study DirectorStudy DirectorBayer

1,180 Previous Clinical Trials

4,261,737 Total Patients Enrolled

Media Library

Riociguat (Adempas, BAY63-2521) (Soluble Guanylate Cyclase Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT01065454 — Phase 2

Pulmonary Hypertension Research Study Groups: Placebo, Riociguat (Adempas, BAY63-2521) fixed 0.5 mg, Riociguat (Adempas, BAY63-2521) up to 2 mg, Riociguat (Adempas, BAY63-2521) up to 1 mg

Pulmonary Hypertension Clinical Trial 2023: Riociguat (Adempas, BAY63-2521) Highlights & Side Effects. Trial Name: NCT01065454 — Phase 2

Riociguat (Adempas, BAY63-2521) (Soluble Guanylate Cyclase Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01065454 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the U.S. Food and Drug Administration accepted Riociguat (Adempas, BAY63-2521) to be marketed?

"Based on the evidence at our disposal, we can safely rate Riociguat (Adempas, BAY63-2521) a 2 out of 3 in terms of safety. This Phase 2 trial has yielded some data indicating its potential for safe use, yet no such studies have been done to confirm efficacy."

Answered by AI

In what geographic areas are participants able to access this trial?

"As it stands, 18 medical centres are participating in this research trial. These locations range from Montreal to Vancouver and Quebec City to name a few. To reduce the burden of travel, try selecting a centre near you if you choose to enroll."

Answered by AI

What other research projects have been conducted involving Riociguat (Adempas, BAY63-2521)?

"Presently, there are two Phase 3 trials and seven other live research studies surveying the effectiveness of Riociguat (Adempas, BAY63-2521). 120 facilities across the globe are running clinical investigations into this drug, with several located in Edmonton, Alberta."

Answered by AI

What criteria must an individual meet to qualify for the research trial?

"In order to meet the eligibility requirements of this investigation, applicants must have hypertension and pulmonary issues in addition to falling between 18-80 years old. This trial is currently recruiting 202 participants."

Answered by AI

Does this trial currently have openings for participants?

"Confirmed. Per the information on clinicaltrials.gov, this particular medical trial is not actively seeking participants at present, despite first being posted in April 2010 and last updated November 2022. However, there are 803 other trials that accept applications from volunteers currently running."

Answered by AI

Is enrollment available to those aged 60 and above in this trial?

"This trial is seeking participants aged between 18 and 80 years old. For those under the age of 18, there are 61 studies available, while over 65s can choose from 713 different trials."

Answered by AI

Is this a pioneering clinical trial?

"Since 2008, Bayer has spearheaded the research of Riociguat (Adempas, BAY63-2521). The first clinical trial was initiated in that same year and involved only 22 participants. From there it gained Phase 2 drug approval before being studied further with 9 active trials spanning 58 cities across 25 countries today."

Answered by AI

To what extent is this clinical trial recruiting participants?

"The trial advertised is no longer looking for participants. First posted on April 14th 2010, the most recent update to this study was November 15th 2022. Currently, there are 794 trials actively enrolling patients with hypertension and pulmonary conditions as well as 9 studies involving Riociguat (Adempas, BAY63-2521) in need of test subjects."

Answered by AI

Recent research and studies

CirculationJournal

Riociguat for Patients with Pulmonary Hypertension Caused by Systolic Left Ventricular Dysfunction

Bonderman, Diana, Stefano Ghio, Stephan B. Felix, Hossein-Ardeschir Ghofrani, Evangelos Michelakis, Veselin Mitrovic, Ronald J. Oudiz, et al.. 2013. “Riociguat for Patients with Pulmonary Hypertension Caused by Systolic Left Ventricular Dysfunction”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.001458.

European Journal of Heart FailureJournal

Left Ventricular Systolic Dysfunction Associated with Pulmonary Hypertension Riociguat Trial (LEPHT): Rationale and Design

Ghio, Stefano, Diana Bonderman, Stephan B. Felix, Hossein A. Ghofrani, Evangelos D. Michelakis, Veselin Mitrovic, Ronald J. Oudiz, Reiner Frey, Lothar Roessig, and Marc J. Semigran. 2012. “Left Ventricular Systolic Dysfunction Associated with Pulmonary Hypertension Riociguat Trial (LEPHT): Rationale and Design”. European Journal of Heart Failure. Wiley. doi:10.1093/eurjhf/hfs071.

clinicaltrials.govStudy

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

2010. "A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01065454.

All > High Blood Pressure > Pulmonary Hypertension