Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
DYNAMIC
Evaluation of the Pharmacodynamic Effects of Riociguat in Subjects With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction in a Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study
2 other identifiers
interventional
118
1 country
1
Brief Summary
The primary objective of this study is to
- Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary hypertension and heart failure with preserved ejection fraction The secondary objectives of this study are to
- Assess safety and tolerability of riociguat in this study population
- Assess changes in dimensions of left and right ventricles and cardiac function parameters using cardiac magnetic resonance imaging
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedNovember 4, 2020
November 1, 2020
4.4 years
March 18, 2016
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of cardiac output at rest, measured by right heart catheterization
Change from baseline of cardiac output at rest, measured by right heart catheterization after 26 weeks of study drug treatment
Baseline and 26 weeks after study drug treatment
Secondary Outcomes (10)
Change from baseline in cardiac magnetic resonance imaging parameters
Baseline and 26 weeks after study drug treatment
Change from baseline in cardiac magnetic resonance imaging parameters
Baseline and 26 weeks after study drug treatment
Change from baseline in cardiac magnetic resonance imaging parameters
Baseline and 26 weeks after study drug treatment
Change from baseline in cardiac magnetic resonance imaging parameters
Baseline and 26 weeks after study drug treatment
Change from baseline in hemodynamic parameters other than cardiac output
Baseline and 26 weeks after study drug treatment
- +5 more secondary outcomes
Other Outcomes (22)
Change from baseline in T1-mapping parameters by CMR
Baseline and 26 weeks after study drug treatment
Change from baseline in T1-mapping parameters by CMR
Baseline and 26 weeks after study drug treatment
Change from baseline in echocardiography parameters
Baseline and 26 weeks after study drug treatment
- +19 more other outcomes
Study Arms (2)
Riociguat
EXPERIMENTALRiociguat up-titrated to a maximum of 1.5mg TID
Placebo
PLACEBO COMPARATORPlacebo sham-titrated TID
Interventions
Eligibility Criteria
You may qualify if:
- to \<80 years of age at the time of informed consent (The lower age limit may be higher if legally required in participating countries.)
You may not qualify if:
- PH-HF-PEF defined as:
- LVEF ≥50%, diagnosed by echocardiography or left heart catheterization (LHC) within 30 days before randomization
- PAPmean ≥25 mmHg at rest, measured by RHC
- PAWP \>15 mmHg at rest, measured by RHC
- Optimized therapy for hypertension
- The dose regimen of the background treatment must have been stable for \>30 days before randomization. Diuretic therapy must have been stable for ≥1 week.
- RHC results for the definite diagnosis of PH not older than 12 weeks at Visit 1. RHC must have been performed in the participating center under standardized conditions
- CMRI must be performed at Visit 1 (baseline) or must not be older than 12 weeks with all parameters measured as listed in Section 7.3.3
- Women are eligible if not of childbearing potential, defined as:
- Postmenopausal women (i.e. last menstrual bleeding at least 2 years before randomization)
- Women with bilateral tubal ligation
- Women with bilateral ovariectomy
- Women with hysterectomy or, if of childbearing potential, women are eligible if
- A serum pregnancy test is negative at the pre-study visit, and The woman uses a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices) for the entire duration of the study.
- Able to understand and follow instructions and to participate in the study for its entire duration
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Bonderman, MD
Medical University of Vienna
- PRINCIPAL INVESTIGATOR
Johannes Kastner, MD
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof.Priv.Doz.Dr.
Study Record Dates
First Submitted
March 18, 2016
First Posted
April 20, 2016
Study Start
March 1, 2016
Primary Completion
August 1, 2020
Study Completion
September 1, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11