(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    30
  • sponsor
    University of Giessen
Updated on 26 January 2021

Summary

Pilot study to determine the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan, evaluated by the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.

Description

In this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan shall be determined by evaluating the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.The method used to determine the RV function will be the "Conductance Method".

Details
Condition Pulmonary Arterial Hypertension
Treatment Riciguat Group, Macitentan Group
Clinical Study IdentifierNCT03362047
SponsorUniversity of Giessen
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female and male patients, 18 years age 85 years
Diagnosis of Pulmonary Hypertension Group 1 according to Nizza Definition (PAH) confirmed by invasive methods, WHO functional class II and III
Existing clinical need to repeat a right ventricular catheter examination (as recommended by the current "Klner Konsensuskonferenz")
Ability to understand study goals and agree to study participation
Hemodynamic criteria of ventricular catheter examination
Pulmonary vascular resistance (PVR)> 240 dyn x sec x cm-5
Mean Pulmonary Arterial Pressure (mPAP) 25 mmHg
Clinical need to receive treatment with a drug approved for the treatment of PAH for the first time
Potentially fertile women must agree to use highly effective methods of contraception, either through abstinence or the use of at least two methods of contraception from the date of consent until one month after the end of the study. An effective pregnancy protection consists in the combination of a hormonal contraceptive (oral, injectable or implant) and a barrier method (condom or diaphragm with a vaginal spermicide)
Written consent to the clinical trial

Exclusion Criteria

Existing therapy with positive inotropic drugs such as Catecholamines
(including norepinephrine, dobutamine, suprarenin)
Pregnancy or breastfeeding
General contraindication for examinations to be performed during the study
Hypersensitivity to the active substances or to a constituent of the study medication (in particular lactose and soya)
Simultaneous participation in another medical therapy study
Simultaneous participation in another non-drug study that would preclude participation in this study
Participation within one month after completing another therapy study
Heavy liver function disorders
Existing increase in liver aminotransferases (aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT))> 3 ULN
Systolic blood pressure <95 mmHg
Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
anemia (Hb <10 g / dl)
Concomitant medication with potential interaction to macitentan and/or riociguat according to the IB
Severe kidney dysfunction
Severe hemoptysis
History of bronchial artery embolization
smoker
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note