Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 9:58 PM
Study NCT ID:
NCT07374302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Riociguat in Triple Therapy for Pulmonary Arterial Hypertension in Real-World Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-24', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-24', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Clinical Outcome at 6 Months', 'timeFrame': '6 months (24±8 weeks) after switch', 'description': 'Composite clinical outcome assessed at 6 months (24±8 weeks) after the switch to riociguat, defined as achievement of at least two of the following criteria: improvement in six-minute walk distance of at least 10% or 30 meters; World Health Organization functional class I or II; and reduction in BNP levels of at least 30%, in the absence of clinical worsening. Clinical worsening is defined as all-cause mortality, hospitalization due to pulmonary arterial hypertension, or unplanned therapeutic escalation.'}], 'secondaryOutcomes': [{'measure': 'Persistence and Time to Discontinuation of Riociguat', 'timeFrame': 'Up to 6 months', 'description': 'reatment persistence at 6 months and time to discontinuation of riociguat for any reason.'}, {'measure': 'Safety Outcomes', 'timeFrame': 'Up to 6 months', 'description': 'Occurrence of adverse events, including symptomatic hypotension, syncope, serious adverse events, and treatment interruptions due to adverse events.'}, {'measure': 'Health Care Utilization', 'timeFrame': '6 months before and 6 months after switch', 'description': 'Occurrence of hospitalizations due to pulmonary arterial hypertension and emergency visits in the 6 months before and after the switch to riociguat.'}, {'measure': 'Functional Changes', 'timeFrame': 'From baseline to 6 months', 'description': 'Changes in functional level before and after the switch to riociguat.'}, {'measure': 'Risk Stratification (COMPERA 2.0)', 'timeFrame': 'From baseline to 6 months', 'description': 'Changes in risk stratification using the COMPERA 2.0 score, when sufficient data are available.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension', 'Riociguat', 'Triple Therapy', 'Real-World Evidence', 'PDE5 Inhibitor Switch', 'Observational Study'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'Pulmonary arterial hypertension is a rare and serious disease that can lead to heart failure and early death despite modern treatments. Many patients are treated with a combination of medications targeting different disease pathways, but some continue to have an inadequate response.\n\nRiociguat is a medication that acts on the nitric oxide pathway and may be beneficial in patients who do not respond well to phosphodiesterase-5 inhibitors. In routine clinical practice, some patients receiving triple therapy switch from a phosphodiesterase-5 inhibitor to riociguat.\n\nThe REAPPRAISED study evaluates outcomes in patients with pulmonary arterial hypertension who switched to riociguat while receiving triple therapy. This observational study uses data from routine clinical care and does not involve any experimental treatment. The results may help improve understanding of the effectiveness and safety of this treatment strategy in real-world practice.', 'detailedDescription': 'Pulmonary arterial hypertension (PAH) is a progressive disease associated with high morbidity and mortality despite the use of combination therapy. Triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor is commonly used; however, a subset of patients shows an inadequate clinical response.\n\nRiociguat is a soluble guanylate cyclase stimulator that increases cyclic GMP through both nitric oxide-dependent and nitric oxide-independent mechanisms. Switching from a phosphodiesterase-5 inhibitor to riociguat has shown clinical benefit in selected patients, but data in real-world settings and in patients already receiving triple therapy remain limited.\n\nREAPPRAISED is a single-center, retrospective, observational study conducted in a pulmonary hypertension referral center. The study evaluates clinical outcomes following the switch from a phosphodiesterase-5 inhibitor to riociguat in patients with PAH receiving triple therapy. All treatment decisions were made by the treating physicians as part of routine clinical care. No study-mandated interventions or treatment assignments were performed, and data were obtained from medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes adult patients with pulmonary arterial hypertension receiving triple therapy who switched from a phosphodiesterase-5 inhibitor to riociguat in routine clinical practice at a specialized referral center. All patients were followed using retrospective data from medical records to assess clinical outcomes, safety, and treatment persistence. No study-related interventions were performed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Adults aged 18 years or older.\n* Confirmed diagnosis of pulmonary arterial hypertension (Group 1).\n* Treatment with triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor for at least 12 weeks.\n* Switch from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care.\n* Availability of minimum data to assess the primary outcome at 6 months.\n\nExclusion Criteria\n\n* Concomitant use of phosphodiesterase-5 inhibitors and riociguat.\n* Inability to confirm vital status or hospitalization outcomes within 6 months.\n* Participation in an interventional clinical trial that mandated the treatment switch.'}, 'identificationModule': {'nctId': 'NCT07374302', 'acronym': 'REAPPRAISED', 'briefTitle': 'Riociguat in Triple Therapy for Pulmonary Arterial Hypertension in Real-World Practice', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'REAPPRAISED: Riociguat in Triple Therapy for Pulmonary Arterial Hypertension - A Single-Center Retrospective Study With Composite Endpoint Evaluation', 'orgStudyIdInfo': {'id': 'SGP 27906'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Riociguat Triple Therapy Cohort', 'description': 'Adult patients with pulmonary arterial hypertension receiving triple therapy who switched from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care. The index date (T0) is defined as the date of riociguat initiation.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Caio Fernandes, Principal Investigator, MD', 'role': 'CONTACT', 'email': 'cjcfernandes@yahoo.com.br', 'phone': '+551126615034'}], 'overallOfficials': [{'name': 'Caio Fernandes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIVERSIDADE SAO PAULO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caio Júlio César dos Santos Fernandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Caio Júlio César dos Santos Fernandes', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}