Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction (ILO-HOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620526
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

BACKGROUND There is no effective medical treatment for heart failure with preserved ejection fraction (HFpEF). Increases in pulmonary capillary wedge pressure (PCWP) develop in patients with HFpEF. Prostacyclin analogo can possible reduced PA pressure along with PWCP pressure, as with exercise.

OBJECTIVES This study try to determine whether inhlalation of iloprost improves exercise hemodynamics and cardiac reserve in HFpEF.

METHODS In a double-blind, randomized, placebo-controlled, parallel-group trial, subjects with HFpEF underwent invasive cardiac catheterization with simultaneous expired gas analysis at rest and during exercise, before and 15 min after treatment with either inhaled iloprost or matching placebo.


Condition or disease Intervention/treatment Phase
Heart Failure With Normal Ejection Fraction Drug: Iloprost Drug: Placebo Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction - the ILO-HOPE Clinical Trial
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

Arm Intervention/treatment
Experimental: Iloprost
patients received inhaled iloprost 10 mcg/mL x 1 dose after baseline and exercise test and then received measurements for hemodynamic data again for both baseline and after exercise test.
Drug: Iloprost
Investigators performed cardiac catheterization as previously described. Hemodynamic values were recorded for the first exercise phase (before any drug administration) and after return to steady state baseline hemodynamic values, and the second exercise phase (after drug administration). Subjects were randomized 1:1 to inhalation of placebo (normal saline solution) or iloprost (50 mg/kg/min) (Bayer Pharmaceuticals, Scottsdale, Ari-zona) for 5 min. The iloprost/placebo inhalation were identical in appearance and prepared by the research pharmacy, ensuring double-blinding of inhalation content. After finishing inhalation process for 10 min, hemodynamic measurements were repeated at rest, followed by repeat supine exercise at a 20-W workload for 6 min, identical to the study's first phase.

Placebo Comparator: Placebo
patients received inhaled normal saline with the same amount x 1 dose after baseline and exercise test and then received measurements for hemodynamic data again for both baseline and after exercise test.
Drug: Placebo
Investigators performed cardiac catheterization as previously described. Hemodynamic values were recorded for the first exercise phase (before any drug administration) and after return to steady state baseline hemodynamic values, and the second exercise phase (after drug administration). Subjects were randomized 1:1 to inhalation of placebo (normal saline solution) or iloprost (50 mg/kg/min) (Bayer Pharmaceuticals, Scottsdale, Ari-zona) for 5 min. The iloprost/placebo inhalation were identical in appearance and prepared by the research pharmacy, ensuring double-blinding of inhalation content. After finishing inhalation process for 10 min, hemodynamic measurements were repeated at rest, followed by repeat supine exercise at a 20-W workload for 6 min, identical to the study's first phase.




Primary Outcome Measures :
  1. Pulmonary wedge pressure changes after exercise measured by swan-ganz catheter (effect of inhalation of drug[efficacy]) [ Time Frame: 15 minutes after inhalation of drugs ]
    Exercise pulmonary wedge pressure changes measured by swan-ganz catheter


Secondary Outcome Measures :
  1. Resing pulmonary wedge pressure measured by swan-ganz catheter (effect of inhalation of drug[efficacy]) [ Time Frame: 15 minutes after inhalation of drugs ]
    resting pulmonary wedge pressure changes measured by swan-ganz catheter

  2. Resting cardiac output as assessed by direct Fick method and heart rate (effect of inhalation of drug[efficacy]) [ Time Frame: 15 minutes after inhalation of drugs ]
    Investigators will measured cardiac output by direct Fick method and heart rate before exercise, after exercise, after inhalation of drugs(placebo/iloprost) and after second exercise. The outcomes will be the absolute value of cardiac output at rest before and after inhalation of the different drug.

  3. Resting pulmonary vascular resistance as assessed by direct Fick method and heart rate (effect of inhalation of drug[efficacy]) [ Time Frame: 15 minutes after inhalation of drugs ]
    Investigators will measured cardiac output and also pulmonary vascular resistance by direct Fick method and heart rate before exercise, after exercise, after inhalation of drugs(placebo/iloprost) and after second exercise. The outcomes will be the absolute value of pulmonary vascular resistance at rest before and after inhalation of the different drug.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. presence of typical HF symptoms and signs
  2. LV ejection fraction ≥ 50
  3. elevated levels of NT-proBNP (at least >125 pg/ml)
  4. echocardiographic structural (a left atrial volume index > 34 mL/m2 or a left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or functional alterations (E/e'≥13 and a mean e' septal and lateral wall < 9 cm/s).

Exclusion Criteria:

  1. chronic renal failure (creatinine > 250 μmol/L)
  2. significant hepatic disease, significant coronary artery disease (CAD) (coronary artery stenosis >70% without intervention or positive stress test),
  3. secondary hypertension,
  4. pericardial disease
  5. significant valvular heart disease (>mild stenosis, >moderate regurgitation),
  6. active cancer,
  7. cor pulmonale
  8. congenital heart disease
  9. high-output heart failure
  10. subjects receiving long-term treatment with phosphodiesterase 5 in-hibitors
  11. chronic atrial fibrillation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620526


Contacts
Layout table for location contacts
Contact: CHO-KAI WU, MD, PhD 886-23123456 ext 62152 chokaiwu@yahoo.com.tw

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: CHO-KAI WU, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: CHO-KAI WU, MD, PhD National Taiwan University Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03620526    
Other Study ID Numbers: 201704075MIND
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Taiwan University Hospital:
Iloprost
Heart failure with preserved ejection fraction
hemodynamic
Pulmonary wedge pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents