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Soluble Guanylate Cyclase Stimulators

Adempas for Exercise Intolerance in Pulmonary Hypertension

Phase 2

Recruiting

Led By Peter Sottile, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Adult patients who underwent PTE for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Awards & highlights

Study Summary

This trial is testing a drug for people who can't exercise well after surgery to clear blockages from their pulmonary arteries.

Who is the study for?

This trial is for adults who had surgery (PTE) for a type of high blood pressure in the lungs caused by clots (CTEPH) at least six months ago and still feel limited when exercising. They must be able to consent and perform exercise tests but can't join if they have ongoing lung pressure issues, are on certain lung medications, or can't take Riociguat due to other health risks.Check my eligibility

What is being tested?

The study is testing Adempas (Riociguat), a medication, on patients who still experience difficulty with physical activity after having surgery for pulmonary hypertension due to blood clots. It's an open-label trial, meaning everyone knows they're getting the drug, not a placebo.See study design

What are the potential side effects?

Adempas may cause side effects like dizziness, headaches, low blood pressure when standing up, stomach problems like nausea or vomiting, bleeding issues such as nosebleeds or coughing up blood.

Eligibility Criteria

Inclusion Criteria

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

Select...

I had surgery for CTEPH over 6 months ago and still feel limited in my ability to exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Pulmonary artery compliance

Change in cardiac output

Change in mean pulmonary arterial pressure

Secondary outcome measures

Change in 6 minute walk test

Change in New York Heart Association (NYHA) functional class

Change in the University of California San Diego (UCSD) shortness of Breath Score

Side effects data

From 2015 Phase 4 trial • 28 Patients • NCT02024386

17%

Bronchospasm

17%

Dizziness

17%

Phlebitis

100%

80%

60%

40%

20%

Study treatment Arm

Riociguat 0.5 mg

Riociguat 1.0 mg

Control Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study DrugExperimental Treatment1 Intervention

Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,506 Total Patients Enrolled

BayerIndustry Sponsor

2,240 Previous Clinical Trials

25,332,757 Total Patients Enrolled

1 Trials studying Exercise Intolerance

280 Patients Enrolled for Exercise Intolerance

Peter Sottile, MDPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

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

Does this trial provide opportunities for elderly participants?

"The criteria for participation in this clinical trial outlines that qualified applicants must be between 18 and 100 years of age. Additionally, there are 7 studies catering to those under the legal minimum, while 81 studies accommodate those over 65."

Answered by AI

What risks or side effects are associated with Adempas usage?

"Adempas has been evaluated to have a safety score of 2, reflecting the fact that while there are some data points around its security profile, no information exists yet on treatment efficacy."

Answered by AI

Has Adempas been tested in other medical experiments?

"Currently, Adempas is being tested in 9 active clinical trials; 2 of them are presently at Phase 3. Edmonton, Alberta serves as the main hub for many of these studies yet there are 120 sites running trials worldwide."

Answered by AI

Is this research pioneering in its field?

"Presently, Adempas is the point of focus for 9 ongoing clinical trials scattered across 25 nations and 58 cities. Originally sponsored by Bayer in 2008, this drug underwent Phase 2 approval with 22 subjects taking part. Since then, an additional 30 studies have been completed."

Answered by AI

Have any openings become available for this investigation?

"Affirmative. Clinicaltrials.gov data specifies that this clinical trial was initially published on June 13th 2018 and most recently amended in August 12th 2022 is actively recruiting participants. 20 people are needed for enrolment at a single medical location."

Answered by AI

What is the eligibility criteria for participation in this experiment?

"To fit the criteria of this clinical trial, potential participants must be between 18 and 100 years old and have been diagnosed with thromboembolism. Approximately 20 people are expected to join in on this medical experiment."

Answered by AI

What is the current sample size of this trial?

"Affirmative. Information hosted on clinicaltrials.gov confirms that recruitment is ongoing for this medical study, which was initially published June 13th 2018 and most recently revised August 12 2022. Twenty patients must be sourced from a single site to participate in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy

2018. "Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03409588.

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