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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
Must not have
Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at visit 6 (16 weeks)

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My pulmonary hypertension is not classified as group 2.1.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16
Secondary study objectives
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%
Nasopharyngitis
12%
Oedema peripheral
12%
Vomiting
12%
Hypotension
11%
Gastrooesophageal reflux disease
11%
Constipation
11%
Chest pain
11%
Dyspnoea
9%
Back pain
8%
Cough
7%
Arthralgia
7%
Insomnia
5%
Influenza
5%
Pneumonia
5%
Bronchitis
5%
Sinusitis
5%
Abdominal pain
5%
Peripheral swelling
5%
Palpitations
5%
Urinary tract infection
5%
Hypokalaemia
5%
Epistaxis
4%
Hypoxia
3%
Cardiac failure acute
3%
Sepsis
3%
Acute kidney injury
3%
Acute respiratory failure
3%
Respiratory failure
1%
Anaemia
1%
Iron deficiency anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Acute left ventricular failure
1%
Gastritis
1%
Rectal haemorrhage
1%
Retroperitoneal haemorrhage
1%
Cholecystitis acute
1%
Cholestasis
1%
Hepatic steatosis
1%
Bronchitis viral
1%
Fluid overload
1%
Hyponatraemia
1%
Thyroid cancer
1%
Pleural effusion
1%
Pulmonary embolism
1%
Respiratory distress
1%
Cardiac resynchronisation therapy
1%
Aortic dissection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Riociguat (Adempas, BAY63-2521)

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

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,274 Previous Clinical Trials
25,514,490 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,664 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
~13 spots leftby Nov 2025
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